Proactiveinvestors United Kingdom Summit Therapeutics PLC https://www.proactiveinvestors.co.uk Proactiveinvestors United Kingdom Summit Therapeutics PLC RSS feed en Fri, 14 Dec 2018 05:14:30 +0000 http://blogs.law.harvard.edu/tech/rss Genera CMS action@proactiveinvestors.com (Proactiveinvestors) action@proactiveinvestors.com (Proactiveinvestors) <![CDATA[News - Summit well-funded as it gears up for ridinilazole phase III trial early next year ]]> https://www.proactiveinvestors.co.uk/companies/news/210983/summit-well-funded-as-it-gears-up-for-ridinilazole-phase-iii-trial-early-next-year-210983.html Summit Therapeutics PLC (LON:SUMM) has told investors it is well-funded as it gears up to begin phase III trials of its ridinilazole C. difficile treatment in the first quarter of next year.

AIM-quoted Summit has previously said that recruitment will take around two years, with the first results coming back in early 2022, give or take a few months.

READ: Summit presents data on new gonorrhoea treatment

Earlier studies have suggested that the precision antibiotic can target C. Diff bacteria without also damaging the natural gut flora. It has also been shown to be better than the current gold standard, vancomycin.

With a healthy bank balance of £13.0mln (Jan 18: £20.1mln), there is plenty of money in the bank to fund operations until next September, according to bosses.

There is also another £14mln (US$18mln) potentially available to Summit from BARDA – a division of the US Department of Health and Human Service which is keen to see more treatments come through.

Gonorrhoea treatment identified, too

After the disappointment of its Ezutromid Duchenne muscular dystrophy drug earlier this year, Summit has reinvented itself to become an antibiotics specialist.

Ridinilazole is at the forefront, but Summit, using its Discuva platform, has identified a potential treatment for gonorrhoea – a sexually transmitted infection which affects an estimated 78mln people every year.

Summit’s compound – SMT-571 – is set to enter a phase I clinical trial in the second half of 2019 and the study will be supported by the US$4.5mln it received from CARB-X, a US programme designed to accelerate the development of new antibiotics.

‘Funding shows promise of candidates’

“The promise of two of our product candidates has been recognised through separate funding awards,” said chief executive Glyn Edwards.

“Ridinilazole continues to garner support from the US government agency, BARDA, which committed a further US$12mln of the up to US$62mln award.”

He added: “We [also] received non-dilutive funding from the public-private partnership CARB-X for SMT-571, our product candidate for the treatment of gonorrhoea.

“We selected SMT-571 as our clinical candidate in the third quarter of 2018 for its selectivity for and potency against N. gonorrhoeae, including multi-drug resistant strains.”

Most recently, the Discuva platform has also yielded “multiple” potential ways to kill hospital-acquired superbugs such as MRSA.

Summit said it has been able to identify genes which are essential for such pathogens to survive, information which it is using to try to develop new drug candidates.

The update came alongside the third-quarter results, during which Summit recorded a loss of £8.1mln compared with a loss of £0.9mln for the year-ago period.

The loss for the current quarter was impacted by a non-cash charge related to the acceleration of share-based payment expense resulting from the surrender of share option awards, the firm said.

Summit shares fell 6.6% to 17.1p in mid-afternoon trading on Tuesday.

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Tue, 11 Dec 2018 13:36:00 +0000 https://www.proactiveinvestors.co.uk/companies/news/210983/summit-well-funded-as-it-gears-up-for-ridinilazole-phase-iii-trial-early-next-year-210983.html
<![CDATA[News - Summit Therapeutics presents data on gonorrhoea treatment at London event ]]> https://www.proactiveinvestors.co.uk/companies/news/209024/summit-therapeutics-presents-data-on-gonorrhoea-treatment-at-london-event-209024.html Summit Therapeutics PLC (LON:SUMM) said its SMT-571 antibiotic has the potential to be used as a front-line treatment for gonorrhoea if approved.

The treatment is the focus of a presentation at the second SCI/RSC Symposium on Antimicrobial Drug Discovery taking place on November 12-13 in London.

READ: Summit Therapeutics to present successful studies of ridinilazole at IDWeek

The company is presenting pre-clinical trial data that shows SMT-571’s effectiveness against gonorrhoea, including cases of resistance to the current recommended treatment.

Current recommended treatment for the sexually transmitted disease is a combination of antibiotics ceftriaxone and azithromycin but Summit said resistance to these drugs is becoming a global issue since there are no approved alternatives.

“By targeting specific infections or pathogens, we believe we can develop the optimal drug for the patient and healthcare provider and improve clinical outcomes,” said Dr David Roblin, president of R&D at Summit.

“This antibiotic stewardship approach promotes the right drug for the right pathogen upfront and preserves broad-spectrum antibiotics for severe, systemic infections.”

The group said SMT-571 appears to have characteristics that are suitable for oral administration and for taking in conjunction with antibiotics for other sexually transmitted diseases.

Summit’s drug pipeline also includes ridinilazole, an antibiotic for C. difficile infection, and a discovery-stage programme for addressing ESKAPE pathogens ( Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa, Enterobacter spp.), commonly referred to as superbugs that cause infections.

READ: Ridinilazole leading the way as Summit Therapeutics pivots to antibiotics

“As bacteria render existing classes of antibiotics less and less effective, infectious diseases are an ever-increasing threat to human life. To counter this threat, Summit Therapeutics is one of the few companies developing genuinely innovative, new mechanism antibiotics,” said Roblin.

He added: “Through our research, we have already found several new vulnerabilities in a range of bacteria, providing us with potential new antibiotic targets to which bacteria have not been previously exposed. Our goal is to use this information to continually develop new mechanism antibiotics to become new standards of care.”

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Mon, 12 Nov 2018 13:26:00 +0000 https://www.proactiveinvestors.co.uk/companies/news/209024/summit-therapeutics-presents-data-on-gonorrhoea-treatment-at-london-event-209024.html
<![CDATA[News - Summit Therapeutics to present successful studies of ridinilazole at IDWeek ]]> https://www.proactiveinvestors.co.uk/companies/news/206292/summit-therapeutics-to-present-successful-studies-of-ridinilazole-at-idweek-206292.html Summit Therapeutics PLC (LON:SUMM) plans to present recent successful studies of its ridinilazole treatment for C. difficile infection (CDI) at the infectious disease conference IDWeek 2018 in San Francisco.

The company, which is on track to begin Phase III clinical trials of ridinilazole in the first quarter of next year, will present previous studies showing that the precision antibiotic can target C. Diff bacteria without also damaging the natural gut flora and that it is better than the current gold standard, vancomycin.

READ: Ridinilazole leading the way as Summit Therapeutics pivots to antibiotics

Dr David Roblin, president of R&D of Summit, said the primary endpoint of the Phase II trial will measure how ridinilazole can treat CDI and reduce recurrent CDI.

“If the phase III clinical trial results are positive, we believe these measures would differentiate ridinilazole in CDI and support its front-line use,” he said.

IDWeek started on Wednesday and runs until Sunday.

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Wed, 03 Oct 2018 12:55:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/206292/summit-therapeutics-to-present-successful-studies-of-ridinilazole-at-idweek-206292.html
<![CDATA[News - Ridinilazole leading the way as Summit Therapeutics pivots to antibiotics ]]> https://www.proactiveinvestors.co.uk/companies/news/205338/ridinilazole-leading-the-way-as-summit-therapeutics-pivots-to-antibiotics-205338.html Summit Therapeutics PLC (LON:SUMM) remains on track to begin phase III clinical trials of its ridinilazole C. difficile treatment in the first quarter of next year.

Recruitment is expected to take around two years, with the first results coming back in early 2022, give or take a few months.

Previous studies have shown that the precision antibiotic can target C. Diff bacteria without also damaging the natural gut flora. It has also been shown to be better than the current gold standard, vancomycin.

Getting ridinilazole into and through phase III trials will be Summit’s primary focus now after the disappointment of its Duchenne muscular dystrophy candidate, ezutromid, this summer.

Ezumotrid disappointment

Interim data for ezutromid published in January was encouraging, but the benefits seen then weren’t sustained for the remainder of the trial.

The data forced Summit to make the “difficult decision” to discontinue the development of the drug, with the company, instead, switching focus to its growing portfolio of antibiotics candidates.

“The world is in desperate need of new antibiotics, and we believe we can deliver with our new mechanism antibiotics covering the most urgent infectious disease threats and a platform that has the potential to continue to unveil novel targets and deliver optimised candidates for the clinic,” said chief executive Glyn Edwards.

“Promising” pipeline

With the DMD drug coming up short, Summit has reinvented itself to become an antibiotics specialist, with ridinilazole at the forefront.

The sector is commanding a lot of attention and investment at the moment, with the World Health Organization recently declaring that antibiotic resistance is “one of the biggest threats to global health”.

Adding weight to that is the government’s estimate that 5,000 people die every year in the UK because antibiotics no longer work for some infections.

READ: Gonorrhoea trial to start next year

Using its Discuva platform, Summit has identified a potential treatment for gonorrhoea – a sexually transmitted infection which affects an estimated 78mln people every year.

Because it is quite common, the bacteria are becoming more and resistant to traditional treatments, which is making it harder to treat.

Summit’s compound – SMT-571 – is set to enter a phase I clinical trial in the second half of 2019 and the study will be supported by the US$4.5mln it received from CARB-X, a US programme designed to accelerate the development of new antibiotics.

READ: Summit identifies possible new ways to treat MRSA

The Discuva platform has also yielded “multiple” potential ways to kill hospital-acquired superbugs such as MRSA.

Summit said it has been able to identify genes which are essential for such pathogens to survive, information which it is using to try to develop new drug candidates.

Well-funded

Summit recorded a profit of £26.6mln in the three months ended July 31, compared to a loss of £3.3mln a year earlier.

The swing to a profit was brought about by the recognition of all deferred revenue related to the Sarepta licence and collaboration agreement following the discontinuation of ezutromid.

At the end of July, Summit had just shy of £17.1mln in the bank, having raised £15mln from investors back in March.

With a raft of cost measures brought in in the wake of the ezutromid disappointment, the company reckons that should be enough to last it until the end of next September.

Summit shares rose 5.4% to 35.3p on Thursday afternoon.

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Thu, 20 Sep 2018 13:00:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/205338/ridinilazole-leading-the-way-as-summit-therapeutics-pivots-to-antibiotics-205338.html
<![CDATA[News - Summit identifies possible new ways to treat hospital-acquired superbugs ]]> https://www.proactiveinvestors.co.uk/companies/news/204340/summit-identifies-possible-new-ways-to-treat-hospital-acquired-superbugs-204340.html Summit Therapeutics PLC (LON:SUMM) reckons it might have found “multiple” new ways to attack and kill hospital-acquired superbugs such as MRSA.

New treatments for the ESKAPE – Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa, Enterobacter spp. – pathogens are needed as they become increasingly resistant to existing antibiotics.

WATCH: Summit Therapeutics sees a bright future for its antibiotics programmes

Using its Discuva platform, Summit said it had identified genes which are essential for these pathogens to survive, information which it will use to try to develop new drug candidates.

Several of these targets are now the focus of Summit’s drug development programmes, with the platform having already discovered potential new mechanism antibiotics against them.

“At the core of our innovation is our powerful Discuva Platform,” said chief executive Glyn Edwards.

“The platform allows us to uncover possible new ways to combat the potentially deadly ESKAPE pathogens.

“We can then aim to exploit this knowledge through the discovery and development of targeted new mechanism antibiotics.”

Shares were up 2% to 38.3p in early afternoon trading.

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Thu, 06 Sep 2018 12:43:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/204340/summit-identifies-possible-new-ways-to-treat-hospital-acquired-superbugs-204340.html
<![CDATA[News - Summit Therapeutics to kick off gonorrhoeae trial next year ]]> https://www.proactiveinvestors.co.uk/companies/news/204231/summit-therapeutics-to-kick-off-gonorrhoeae-trial-next-year-204231.html Summit Therapeutics PLC (LON:SUMM, NASDAQ:SMMT) said it will kick off a Phase I clinical trial of a new antibiotic for gonorrhoea in the second half of next year.

It follows the nomination of SMT-571 as its lead candidate to tackle the sexually transmitted infection.

READ: Summit Therapeutics awarded additional US$12mln under contract with US BARDA

Identified using the company’s Discuva Platform, it is designed to exploit the N. gonorrhoeae target.

The study itself will be supported by the US$4.5mln it received from CARB-X, a US programme designed to accelerate the development of new antibiotics.

The need for new treatments for gonorrhoea was laid bare last week when the Centers for Disease Control and Prevention showed that cases of the STI had increased by 67% between 2013 and 2017.

Worrying also was the rise in drug-resistant strains of the infection.

“We believe our new science and new way of thinking together enable our goal to develop the right drug for the right pathogen and create opportunities for success,” said Dr David Roblin, Summit’s head of R&D of Summit.

“SMT-571 is being developed specifically for gonorrhoea, meaning that it is designed to have both a targeted spectrum of activity and be tailored to meet the needs of patients with gonorrhoea.”

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Wed, 05 Sep 2018 12:41:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/204231/summit-therapeutics-to-kick-off-gonorrhoeae-trial-next-year-204231.html
<![CDATA[News - Summit Therapeutics awarded additional US$12mln under contract with US BARDA ]]> https://www.proactiveinvestors.co.uk/companies/news/203060/summit-therapeutics-awarded-additional-us12mln-under-contract-with-us-barda-203060.html Summit Therapeutics PLC (LON:SUMM) (NASDAQ:SMMT) announced that it has been awarded an additional US$12mln under its contract with the US Biomedical Advanced Research and Development Authority (BARDA).

The AIM-listed group said the funds from BARDA - a division of the US Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response - will support the Phase 3 development programme for ridinilazole, the company's precision new mechanism antibiotic for the treatment of C. difficile infection.

READ: Summit Therapeutics encouraged by performance of C.diff treatment in latest trial

Glyn Edwards, Summit’s chief executive officer commented: "BARDA's continued support underlines the promise ridinilazole has as a potential front-line CDI treatment option which can treat the initial infection and address the key clinical issue of recurrent disease.”

He added: "We look forward to the planned initiation of the Phase 3 clinical trials which remains on track for the first quarter of 2019."

Summit said the latest award represents the first of three optional awards to be exercised under the BARDA contract, and brings the total committed BARDA funding to US$44mln, which includes the base package of US$32mln announced in September 2017.

The group pointed out that if BARDA exercises its remaining options in full, the total funding under the contract would increase up to US$62mln.

The company said the US$12mln funding will be drawn down to specifically support drug manufacturing activities required for the submission of marketing approval applications and other regulatory activities.

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Thu, 16 Aug 2018 12:17:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/203060/summit-therapeutics-awarded-additional-us12mln-under-contract-with-us-barda-203060.html
<![CDATA[News - Summit Therapeutics encouraged by performance of C.diff treatment in latest trial ]]> https://www.proactiveinvestors.co.uk/companies/news/202181/summit-therapeutics-encouraged-by-performance-of-cdiff-treatment-in-latest-trial-202181.html Summit Therapeutics PLC’s (LON:SUMM) shares jumped on Friday after the firm said its new treatment for superbug C-difficile outperformed the current standard of care in its latest clinical trial.

In the phase II CoDIFy trial, Summit’s drug, Ridinilazole, was more effective than the widely prescribed Vancomycin in preserving the gut microbiome, which is known to be important in protecting both against the initial infection and its recurrence. With this microbiome preservation, ridinilazole treatment resulted in a 59% reduction in recurrence compared to vancomycin (14.3% vs. 34.8%, respectively).”

WATCH: Summit Therapeutics sees a bright future for its antibiotics programmes

Ridinilazole also demonstrated clinical and statistical superiority over vancomycin in sustained clinical response, which measures cure and recurrence over thirty days, said Summit.

"These results show how the precision action of ridinilazole against C. difficile, and its corresponding lack of impact on the broader microbiome, led to greatly increased rates of sustained cures through decreased disease recurrence,” said Dr David Roblin, Summit’s President of R&D.

Better prevention of recurrence is the next frontier in CDI therapy, he added.

"Ridinilazole may have the potential to become new standards of care for serious bacterial infections."

The results from the CoDIFy Phase 2 trial were published in the PLOS One journal.

Summit has received financial backing for the drug from the Biomedical Advanced Research and Development Authority (BARDA) in the US and is eligible to receive up to US$62mln in funding to support the clinical and regulatory development of ridinilazole.

Phase 3 clinical trials are expected to begin in the first quarter of next year.

The UK-listed company is pinning its hopes on ridinilazole after ezutromid, its treatment for muscle wasting disease DMD, failed its most recent clinical trial.

In late morning trading, Summit shares were almost 20% higher at 42.5p.

 -- Adds share price --

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Fri, 03 Aug 2018 07:57:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/202181/summit-therapeutics-encouraged-by-performance-of-cdiff-treatment-in-latest-trial-202181.html
<![CDATA[Media files - Summit Therapeutics sees a bright future for its antibiotics programmes ]]> https://www.proactiveinvestors.co.uk/companies/stocktube/9823/summit-therapeutics-sees-a-bright-future-for-its-antibiotics-programmes-9823.html Wed, 11 Jul 2018 14:09:00 +0100 https://www.proactiveinvestors.co.uk/companies/stocktube/9823/summit-therapeutics-sees-a-bright-future-for-its-antibiotics-programmes-9823.html <![CDATA[News - Summit Therapeutics receives grant to further its development of a treatment for gonorrhoea ]]> https://www.proactiveinvestors.co.uk/companies/news/200480/summit-therapeutics-receives-grant-to-further-its-development-of-a-treatment-for-gonorrhoea-200480.html Drug developer Summit Therapeutics PLC (LON:SUMM, NASDAQ:SMMT) has been awarded a US$4.5mln grant from CARB-X to develop its antibiotic compounds for gonorrhoea.

CARB-X is a public-private partnership devoted to accelerating early antibiotic research and development.

WATCH: Summit Therapeutics sees a bright future for its antibiotics programmes

Summit will receive an initial US$2.0mln in funding from CARB-X that will in part fund the selection of a preclinical candidate from Summit’s lead gonorrhoea series. The selection of a lead candidate is expected in the second half of 2018.

The remaining US$2.5mln is split into two option segments, which may be exercised by CARB-X upon the achievement of certain development milestones. If exercised in full, this funding could support the development of the selected gonorrhoea candidate through the end of a Phase 1 clinical trial.

“This CARB-X collaboration and funding is important to us as we aim to pioneer a new era in antibiotic innovation and allows us to accelerate the development of our first series of new mechanism of action gonorrhoea compounds,” said Glyn Edwards, the chief executive officer (CEO) of Summit.

“The award is a testament to the promise of our gonorrhoea programme, and the discovery capability of our proprietary genetics-based platform,” he added.

Resistance to antibiotics used to treat the STI is growing

The World Health Organization (WHO) estimates that there are around 78mln new cases of gonorrhoea each year and the number of antibiotics that can combat Neisseria gonorrhoeae has now declined to just one treatment recommended by the Centers for Disease Control and Prevention (CDC).

The WHO ranks as “high” the priority of research & development investment into the search for antibiotics that are effective against Neisseria gonorrhoea.

“Drug-resistant gonorrhoea is an urgent and growing public health problem around the world, affecting the health and quality of life of millions of people,” said Kevin Outterson, the executive director of CARB-X.

“The world urgently needs new antibiotics, like those that Summit is developing, and other life-saving products to protect us from drug-resistant bacteria. The projects in the Powered by CARB-X portfolio are in the early stages of development, but if successful, they offer tremendous potential in the fight against superbugs,” he added.

Speaking to Proactive Investors, Summit CEO Glyn Edwards said there had been "an innovation deficit" over the last two decades when it came to antibiotics.

"There has been no new class of antibiotics in 20 years," he explained. Moving from one antibiotic to another antibiotic in the same class has been the normal behaviour as microbes develop resistance to the previous treatments. Now, however, "the cupboard is bare", Edwards said.

Shares in Summit, which plummeted earlier this month when the company’s treatment for Duchenne’s muscular dystrophy (DMD) failed a clinical trial, rose 10% to 38.5p on the news.

Edwards acknowledged that the DMD test result was a severe blow to the company but it has now left the company focused entirely on novel antibiotics. "It's a much cleaner story," he said.

"It's true that most investors [in Summit] were most excited by the DMD treatment and those investors have now exited. Others are excited by the antibiotics story; it's potentially a huge value driver for the company," Edwards declared.

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Tue, 10 Jul 2018 12:37:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/200480/summit-therapeutics-receives-grant-to-further-its-development-of-a-treatment-for-gonorrhoea-200480.html
<![CDATA[News - Summit’s focus firmly on ridinilazole after DMD disappointment ]]> https://www.proactiveinvestors.co.uk/companies/news/199691/summits-focus-firmly-on-ridinilazole-after-dmd-disappointment-199691.html Summit Therapeutics PLC (LON:SUMM) is to focus on its ridinilazole C. difficile treatment following the disappointing results from a mid-stage study of its Duchenne muscular dystrophy drug.

Ridinilazole, Summit’s lead candidate, is due to enter phase III trials in the first quarter of 2019.

READ: PhaseOut study doesn’t meet primary endpoint

Recruitment is expected to take around two years, with the first results coming back in early 2022, give or take a few months.

Previous studies have shown that the precision antibiotic can target C. Diff bacteria without also damaging the natural gut flora. It has also been shown to be better than the current gold standard, vancomycin.

Getting ridinilazole into and through phase III trials will be Summit’s primary focus now after the disappointment of its DMD candidate, ezutromid.

Ezumotrid disappointment

It was only in January when the market was getting excited about the prospects for ezutromid following encouraging interim data from the PhaseOut study.

Back then, the firm said ezutromid had had a “statistically significant and meaningful” effect in reducing muscle damage in patients.

But the benefits seen at the half-way stage weren’t sustained for the remainder of the trial, forcing Summit to make the “difficult decision” to discontinue the development of the drug.

“While we believe utrophin modulation could still have a place in the treatment of DMD, it is clear that ezutromid is not providing a benefit for patients,” said chief executive Glyn Edwards.

“We therefore feel that our resources are better focussed on the development of our promising pipeline of new mechanism antibiotics.”

“Promising” pipeline

Summit has more to its game than just ezutromid and ridinilazole.

Using its Discuva drug discovery platform, the company has identified two possible compounds for gonorrhoea – a sexually transmitted infection which affects an estimated 78mln people every year.

Because it is quite common, the bacteria are becoming more and resistant to traditional treatments, which is making it harder to treat.

READ: Summit snaps up antibiotics discovery group Discuva for £10mln

In early testing, Summit’s two antibiotic compounds have shown high potency against gonorrhoea bacteria with no development of resistance so far.

The company has high hopes for the series of compounds and reckons they have the potential to produce a new front-line therapy for gonorrhoea.

The aim is to select a candidate from the lead series of compounds for progression into IND-enabling (investigational new drug) studies in the second half of 2018. Assuming the IND application is cleared, the treatment will then make its way into the clinic.

Strong cash position

At the end of April, Summit had just shy of £28mln in the bank, having raised £15mln from investors back in March.

At the time, the company said that would last it until next spring. Given that it is bringing in cost reduction measures in the wake of the DMD disappointment, management said in a conference call that it could last even longer, although it is reluctant to put an exact date on it.

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Wed, 27 Jun 2018 13:54:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/199691/summits-focus-firmly-on-ridinilazole-after-dmd-disappointment-199691.html
<![CDATA[News - Summit Therapeutics says PhaseOut DMD clinical trial did not meet primary endpoint ]]> https://www.proactiveinvestors.co.uk/companies/news/199681/summit-therapeutics-says-phaseout-dmd-clinical-trial-did-not-meet-primary-endpoint-199681.html Summit Therapeutics PLC (LON:SUMM; NASDAQ:SMMT) said that its PhaseOut DMD has not met its primary or secondary endpoints after 48 weeks of treatment of ezutromid in patients with Duchenne muscular dystrophy (DMD).

The AIM-listed pharmaceuticals group said that because of the outcome, it is discontinuing its development of ezutromid and as a result, will be implementing cost reduction measures.

READ: Summit Therapeutics unveils second series of compounds which could kill gonorrhoea bacteria

Summit added that it would now focus its operations on the development of its pipeline of new mechanism antibiotics, with its lead product candidate, ridinilazole, expected to enter Phase 3 clinical trials for the treatment of C. difficile infection in the first quarter of 2019.

The company also said it would investigate whether information gathered as part of PhaseOut DMD phase 2 clinical trial could be made available to support other research activities in DMD for the benefit of the DMD community.

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Wed, 27 Jun 2018 12:25:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/199681/summit-therapeutics-says-phaseout-dmd-clinical-trial-did-not-meet-primary-endpoint-199681.html
<![CDATA[News - Summit Therapeutics unveils second series of compounds which could kill gonorrhoea bacteria ]]> https://www.proactiveinvestors.co.uk/companies/news/198590/summit-therapeutics-unveils-second-series-of-compounds-which-could-kill-gonorrhoea-bacteria-198590.html Summit Therapeutics PLC (LON:SUMM) has discovered a second series of “promising” compounds which it believes could be used to treat gonorrhoea.

Back in April, the AIM-quoted group revealed it had found a different series of new mechanism antibiotics for the sexually transmitted infection which is notoriously difficult to treat because of its high resistances rates.

READ: Summit discovers new potential antibiotics for gonorrhoea

Initial research has suggested that these new compounds have the characteristics to kill the bacteria, including the resistant strains.

“Gonorrhoea poses an urgent threat as the world approaches an era of untreatable disease due to increasing resistance against the last recommended treatment option," said Summit’s president of R&D, David Roblin.

“Having two novel approaches with the potential to combat gonorrhoea means Summit has an opportunity to meaningfully contribute to the fight against this significant worldwide health threat.”

Both series of compounds were identified using Summit’s Discuva platform – a genetics-based technology used for the discovery and development of new antibiotics against infections generally associated with antibiotic resistance.

Roblin added: “We believe our Discuva Platform has the potential to radically change antibiotic drug discovery and development.”

Currently there is only on treatment option for gonorrhoea recommended by the US Centres for Disease Control, although the bacteria’s resistance is rising all the time.

The World Health Organisation estimates there are 78mln new cases of the infection around the world every year.

Summit shares edged 0.8% to 194p.

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Mon, 11 Jun 2018 08:40:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/198590/summit-therapeutics-unveils-second-series-of-compounds-which-could-kill-gonorrhoea-bacteria-198590.html
<![CDATA[News - Summit Therapeutics chief hails potential of drug that treats fatal childhood disease ]]> https://www.proactiveinvestors.co.uk/companies/news/198276/summit-therapeutics-chief-hails-potential-of-drug-that-treats-fatal-childhood-disease-198276.html Summit Therapeutics PLC (LON:SUMM, NASDAQ:SMMT) chief executive Glyn Edwards believes the company’s phase II drug could be the new standard of care for children with Duchenne muscular dystrophy, a fatal muscle-wasting disease that affects boys.

His assessment of the potential of ezutromid followed the release of 24-week data from the company’s clinical study of the treatment, which revealed a statistically significant and meaningful reduction in both muscle damage and inflammation.

READ: Summit Therapeutics discovers new potential antibiotics for gonorrhoea

“The strength of the interim data from our PhaseOut DMD trial has bolstered our belief that ezutromid could become a new standard of care for all patients with Duchenne muscular dystrophy,” Edwards said in an update alongside the company’s first-quarter results.

The read-out from the completed second-phase trial is expected in the third-quarter.

The company’s second drug, next-generation antibiotic ridinilazole, is expected to undergo a phase III trial in the first three months of next year.

Financially, Summit is in a strong position. A £15mln share placing helped bolster Summit’s bank balance, which was £27.7mln at the end of April. The company posted a loss of £5.8mln for the three months ended April 30.

 

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Tue, 05 Jun 2018 12:30:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/198276/summit-therapeutics-chief-hails-potential-of-drug-that-treats-fatal-childhood-disease-198276.html
<![CDATA[News - Summit Therapeutics discovers new potential antibiotics for gonorrhoea ]]> https://www.proactiveinvestors.co.uk/companies/news/195563/summit-therapeutics-discovers-new-potential-antibiotics-for-gonorrhoea-195563.html Summit Therapeutics PLC (LON:SUMM) told investors that it highlighted the discovery of new mechanism antibiotic candidates for the treatment of gonorrhoea at an industry event in Europe.

It was disclosed in a ‘late-breaking’ presentation at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) held in Madrid, Spain.

"Our strategy to tackle difficult to treat bacterial infections, such as gonorrhoea, is clear: to develop new mechanism antibiotics that are genuinely innovative treatment options with the potential to replace existing standards of care," said Dr David Roblin, Summit president of research and development.

READ: Summit Therapeutics boosted by new DMD drug analysis

He added: "We are encouraged by the profile of the series of gonorrhoea antibiotic candidates developed using our proprietary genetics-based discovery platform, and we look forward to selecting a preclinical candidate in the second half of this year."

Summit noted that gonorrhoea is an area of high unmet medical need with only one treatment option recommended by the US Centres for Disease Control, and, additionally, it is identified as a priority pathogen by the World Health Organisation.

The company highlighted that data presented at ECCMID showed a high potency against a range of gonorrhoea strains, including ones that were multi-drug resistant, high selectivity for gonorrhoea which minimises collateral damage to the microbiome.

Additionally, there was low potential for resistance development, and suitability for oral administration, it added.

Summit said it intends to select a candidate to enter studies in the second half of this year.

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Mon, 23 Apr 2018 12:52:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/195563/summit-therapeutics-discovers-new-potential-antibiotics-for-gonorrhoea-195563.html
<![CDATA[News - Summit Therapeutics boosted by new DMD drug analysis ]]> https://www.proactiveinvestors.co.uk/companies/news/195472/summit-therapeutics-boosted-by-new-dmd-drug-analysis-195472.html Summit Therapeutics PLC (LON:SUMM, NASDAQ:SMMT) has highlighted new analysis from the group’s Phase Two clinical trial, for its potential treatment for Duchenne muscular dystrophy (DMD).

The company, in a statement, said the new analysis showed a high correlation between reductions in developmental myosin, a biomarker of muscle damage, and reductions in muscle inflammation in patients after 24 weeks of ezutromid treatment.

READ: Summit Therapeutics boosted by new DMD drug analysis

It added that the findings underpin existing evidence that Summit’s drug, ezutromid, is reducing the severity of DMD.

"The correlation observed between decreases in developmental myosin, a biomarker of muscle damage, and decreases in muscle fibre inflammation, is highly encouraging, and we believe further supports that ezutromid is breaking the DMD disease cycle of muscle damage and repair," said Dr David Roblin, Summit chief medical officer.

“We look forward to reporting the full results of this trial, expected in the third quarter of 2018."

Summit shares climbed 11.5p or 5.97% to trade at 204p.

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Fri, 20 Apr 2018 12:49:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/195472/summit-therapeutics-boosted-by-new-dmd-drug-analysis-195472.html
<![CDATA[Media files - Summit Therapeutics accelerating preparatory activities for next DMD study ]]> https://www.proactiveinvestors.co.uk/companies/stocktube/9113/summit-therapeutics-accelerating-preparatory-activities-for-next-dmd-study-9113.html Thu, 19 Apr 2018 16:27:00 +0100 https://www.proactiveinvestors.co.uk/companies/stocktube/9113/summit-therapeutics-accelerating-preparatory-activities-for-next-dmd-study-9113.html <![CDATA[News - Summit Therapeutics completes dosing of ezutromid in PhaseOut DMD clinical trial ]]> https://www.proactiveinvestors.co.uk/companies/news/195368/summit-therapeutics-completes-dosing-of-ezutromid-in-phaseout-dmd-clinical-trial-195368.html Summit Therapeutics PLC (NASDAQ:SMMT, LON:SUMM) said ezutromid dosing in patients with Duchenne muscular dystrophy (DMD) for the full 48-week PhaseOut DMD clinical trial has been completed.

Top-line results from the full trial continue to be expected in the third quarter of 2018, the company said in a statement.

WATCH: Summit Therapeutics accelerating preparatory activities for next DMD study

Summit's utrophin modulator, ezutromid, is a potential breakthrough treatment for sufferers of DMD, a fatal wasting disease that affects boys and young men.

Interim data from the trial has already revealed a statistically significant reduction in muscle damage and inflammation in patients after just 24-weeks.

READ: Summit Therapeutics shares jump on initial positive results of clinical trial for DMD​

"We believe the early improvements seen in muscle health in the interim data from PhaseOut DMD indicate ezutromid is reducing DMD disease severity. In the full trial results, we aim to see continued utrophin modulation and sustained changes in magnetic resonance parameters,” said Dr David Roblin, the chief medical officer and president of research & development at Summit.

"These results, if positive, could form the basis of a regulatory filing of ezutromid, bringing this universal treatment to patients more rapidly," he added.

 

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Thu, 19 Apr 2018 12:49:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/195368/summit-therapeutics-completes-dosing-of-ezutromid-in-phaseout-dmd-clinical-trial-195368.html
<![CDATA[News - Summit Therapeutics boss hails "landmark year"; investors look to next milestone ]]> https://www.proactiveinvestors.co.uk/companies/news/194744/summit-therapeutics-boss-hails-landmark-year-investors-look-to-next-milestone-194744.html Summit Therapeutics PLC (LON:SUMM, NASDAQ:SMMT) chief executive Glyn Edwards described 2017 as a “landmark year”, though investors are already looking to the third-quarter of this year for the next major milestone.

Eagerly anticipated by the investing public are the top-line results for ezutromid, a potential breakthrough treatment for sufferers of Duchenne Muscular Dystrophy (DMD), a fatal wasting disease that affects boys.

The read-out from the Phase II proof-of-concept study is expected from September onwards; however, interim data has already revealed a statistically significant reduction in muscle damage and inflammation in patients after just 24-weeks.

Preparations accelerated

“Strongly encouraged by these findings, we are accelerating preparatory activities for a placebo-controlled trial of ezutromid and also preparing for a potential regulatory filing of ezutromid based on top-line data from the full 48-week results,” said Edwards.

Summit also had success with its precision antibiotic, which received backing from the Biomedical Advanced Research and Development Authority in the US – a package that’s potentially worth £44mln (US$62mln).

Researchers currently are preparing to take C.difficile combatant ridinilazole into Phase III clinical trials in the States and here in Europe.

Finally, the acquisition in December for £10mln in cash and paper has brought in an earlier stage antibiotic pipeline.

Financially strong

Financially, Summit is in a strong position, ending the year with just over £20mln in the bank, which was supplemented last month with a £15mln fundraiser.

The loss for the 12 months to January 31 shrank to £7.1mln from £21.4mln.

READ: Summit Therapeutics raises around £15mln from placing to advance its treatment for Duchenne Muscular Dystrophy

“We enter this next year in a position of strength with great opportunities for our products,” said chairman Frank Armstrong.

“Our progress brought us one step closer to realising the significant value of ezutromid and ridinilazole for the company, shareholders and most importantly, patients.

“Our growth over the past year ensures we have a strong team and a pipeline for the future.

“We now look to an exciting year ahead with the full results from PhaseOut DMD expected in the third quarter of this year.”

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Wed, 11 Apr 2018 12:33:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/194744/summit-therapeutics-boss-hails-landmark-year-investors-look-to-next-milestone-194744.html
<![CDATA[News - Summit Therapeutics raises around £15mln from placing to advance its treatment for Duchenne Muscular Dystrophy ]]> https://www.proactiveinvestors.co.uk/companies/news/193847/summit-therapeutics-raises-around-15mln-from-placing-to-advance-its-treatment-for-duchenne-muscular-dystrophy-193847.html Summit Therapeutics PLC (LON:SUMM) (NASDAQ: SMMT) has raised around £15mln from an accelerated book-build placing of 8,333,333 new ordinary shares, at a price of 180p each, to advance its treatment for Duchenne Muscular Dystrophy (DMD).

The AIM-listed group noted that the placing price represents a discount of 5.3% to its closing mid-market price on 26 March 2018 of 190p, and the maximum number of placing shares issued represent approximately 10.2% of the company's enlarged issued share capital. In early afternoon trading, Summit shares held steady at 190p.

READ: Summit Therapeutics presents poster on Phase Out DMD clinical trial

The company said the completed placing, which was oversubscribed, received support from both existing and new shareholders.     

The group expects to use the placing’s net proceeds to accelerate preparatory activities for a placebo-controlled clinical trial for DMD treatment ezutromid, and for a potential regulatory filing of ezutromid based on the 48-week results from the ongoing Phase 2 clinical trial.

It added that the funds will also be used to continue development of the company's utrophin modulator and infectious disease pipeline activities, and support initiation of the Phase 3 clinical trials of ridinilazole for C. difficile infection that are planned to commence in the first quarter of 2019.

Glyn Edwards, Summit’s chief executive officer, commented: "We are pleased with the level of interest from both existing and new investors in supporting our plans to advance ezutromid, our utrophin modulator for DMD.”

He added: "The funds from this placing will provide us clinical and regulatory flexibility as we seek to rapidly advance ezutromid and bring this potentially transformational therapy to patients as quickly as possible."

Summit recently announced positive interim 24-week data from its PhaseOut DMD clinical trial which showed that ezutromid significantly reduced muscle damage and inflammation in patients with DMD.

Edwards said: “We look forward to the full 48-week trial data in the third quarter of 2018 which could further support the disease modifying potential of ezutromid as a treatment for all patients with DMD."

Panmure Gordon (UK) Limited and N+1 Singer Advisory LLP acted as joint brokers and joint bookrunners in relation the placing, which was not underwritten.

 -- Adds completed placing details, share price --

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Tue, 27 Mar 2018 07:40:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/193847/summit-therapeutics-raises-around-15mln-from-placing-to-advance-its-treatment-for-duchenne-muscular-dystrophy-193847.html
<![CDATA[News - Summit Therapeutics presents poster on Phase Out DMD clinical trial ]]> https://www.proactiveinvestors.co.uk/companies/news/193161/summit-therapeutics-presents-poster-on-phase-out-dmd-clinical-trial-193161.html Summit Therapeutics PLC (LON:SUMM, NASDAQ:SMMT) has been banging the drum at the 2018 MDA Clinical Conference in Arlington, Virginia, about its PhaseOut DMD clinical trial.

Summit stressed the scientific rigour of PhaseOut DMD, a Phase 2 open-label trial of the company's utrophin modulator, ezutromid, in patients with Duchenne muscular dystrophy (DMD).

READ: Summit Therapeutics shares jump on 'exciting' interim results of ezutromid study

Through this study, Summit is compiling a deep dataset for each patient in the trial, which includes the analysis of several thousand muscle fibres per biopsy sample.

As part of this effort, steps are being taken to remove human bias through the automated reading of biopsy and modified Rankin scale (MRS) measurements at central sites.

"Since DMD is a muscle-wasting disorder, it is critical for us to have high quality data from objective muscle health measurements as we assess ezutromid's activity.

As the collection of muscle biopsy and MRS measurements are a major intervention for patients in clinical trials, it means it is crucial this is done in a robust and reliable way," said Dr David Roblin, the chief medical officer and president of research & development at Summit.

READ: Summit Therapeutics expands enrolment in Phase 2 PhaseOut DMD trial

"Our data collection and analysis methods used in PhaseOut DMD helped yield a high-quality dataset from all evaluable boys in the trial after 24-weeks of treatment. We are grateful to all the boys in the trial and excited about the interim findings that showed compelling signs of ezutromid activity," Dr Roblin said.

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Wed, 14 Mar 2018 12:22:00 +0000 https://www.proactiveinvestors.co.uk/companies/news/193161/summit-therapeutics-presents-poster-on-phase-out-dmd-clinical-trial-193161.html
<![CDATA[News - Summit Therapeutics discovers new antibiotic compounds in fight against gonorrhoea ]]> https://www.proactiveinvestors.co.uk/companies/news/193074/summit-therapeutics-discovers-new-antibiotic-compounds-in-fight-against-gonorrhoea-193074.html Summit Therapeutics PLC (LON:SUMM) shares jumped almost 7% higher on Tuesday after the biopharma firm said its Infectious Diseases Technology Platform has discovered a series of antibiotic compounds that kill gonorrhoea bacteria.

The AIM-listed company said that in early testing the new compounds had been shown to have high potency against strains of gonorrhoea with no development of resistance to date.

READ: Summit Therapeutics expands enrolment in Phase 2 PhaseOut DMD trial

The firm added that it intended to select a candidate from the programme for Investigational New Drug (IND) enabling studies in the second half of 2018.

Dr David Roblin, president of R&D at Summit, said: "Without truly novel mechanism antibacterial drugs we cannot address the issue of antimicrobial resistance. Nowhere is this need more obvious than in gonorrhoea, where increasing resistance and a lack of innovation means we are now nearing an era of untreatable disease."

"Tackling this disease therefore fits squarely within Summit's strategic vision: the development of new mechanism therapies designed to treat specific diseases. This approach aims to demonstrate clear advantages over existing standards of care combined with a compelling value proposition for patients, payors and healthcare providers", he added.

In afternoon trading, Summit Therapeutics' shares were 6.7% higher at 200p.

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Tue, 13 Mar 2018 11:30:00 +0000 https://www.proactiveinvestors.co.uk/companies/news/193074/summit-therapeutics-discovers-new-antibiotic-compounds-in-fight-against-gonorrhoea-193074.html
<![CDATA[News - Summit Therapeutics expands enrolment in Phase 2 PhaseOut DMD trial ]]> https://www.proactiveinvestors.co.uk/companies/news/192765/summit-therapeutics-expands-enrolment-in-phase-2-phaseout-dmd-trial-192765.html Summit Therapeutics PLC (NASDAQ:SMMT, LON:SUMM) has opened enrolment in a planned additional group in its Phase 2 open-label clinical trial called PhaseOut DMD.

PhaseOut DMD is a trial of ezutromid, Summit's drug candidate for the treatment of Duchenne Muscular Dystrophy, a rare muscle-wasting disease that affects boys and young men.

READ: Summit Therapeutics shares jump as initial results of clinical trial for Duchenne muscular dystrophy treatment shows "further positive findings"

Enrolment is open to patients who participated in Phase 1 clinical trials of ezutromid but who did not meet the entry criteria for the main PhaseOut DMD cohorts.

Study assessments will include functional tests appropriate for the patient's ambulatory status, cardiac magnetic resonance imaging (MRI) and lung function tests.

"We are extremely grateful to the patients who participated in our Phase 1 clinical trials and contributed to ezutromid's clinical advancement, but were not initially eligible to participate in our Phase 2 clinical trial. Accordingly, we are pleased to open this additional group in our Phase 2 and provide these patients with the opportunity to receive ezutromid treatment," said Dr David Roblin, the chief operating officer and medical officer of Summit. 

"We expect the data collected from this additional group of patients will help expand our understanding of ezutromid's safety and efficacy profile across a broader patient population," he added.

Shares in Summit were up a penny at 181p in lunchtime trading.

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Wed, 07 Mar 2018 12:51:00 +0000 https://www.proactiveinvestors.co.uk/companies/news/192765/summit-therapeutics-expands-enrolment-in-phase-2-phaseout-dmd-trial-192765.html
<![CDATA[News - Summit Therapeutics shares jump as initial results of clinical trial for Duchenne muscular dystrophy treatment shows "further positive findings" ]]> https://www.proactiveinvestors.co.uk/companies/news/192181/summit-therapeutics-shares-jump-as-initial-results-of-clinical-trial-for-duchenne-muscular-dystrophy-treatment-shows-further-positive-findings--192181.html Summit Therapeutics PLC (LON:SUMM, NASDAQ:SMMT) saw its shares jump nearly 9% on Monday in London after the group revealed that its clinical trial for the treatment of Duchenne muscular dystrophy provided "further positive findings" for its utrophin modulator ezutromid.

In a statement, the AIM-listed biotech firm said initial 24-week results from the 48-week Phase II PhaseOut DMD clinical trial showed a "statistically significant decrease" in muscle inflammation as measured by magnetic resonance spectroscopy transverse relaxation time T2.

WATCH: Summit Therapeutics hugely excited after big DMD ‘breakthrough’

David Roblin, Summit’s chief medical officer and research & development president said. "The 24-week interim analysis has shown encouraging signs of ezutromid activity in PhaseOut DMD. These MRS-T2 findings show a positive impact on downstream muscle health.”

He added: "This, combined with the evidence that ezutromid can modulate production of utrophin protein and significantly reduce muscle damage, is further evidence of the potential of ezutromid as a disease-modifying approach for the treatment of all genetic forms of DMD."

In early afternoon trading, Summit shares were up 8.8% at 185p.

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Mon, 26 Feb 2018 12:57:00 +0000 https://www.proactiveinvestors.co.uk/companies/news/192181/summit-therapeutics-shares-jump-as-initial-results-of-clinical-trial-for-duchenne-muscular-dystrophy-treatment-shows-further-positive-findings--192181.html
<![CDATA[Media files - Summit Therapeutics hugely excited after big DMD ‘breakthrough’ ]]> https://www.proactiveinvestors.co.uk/companies/stocktube/8671/summit-therapeutics-hugely-excited-after-big-dmd-breakthrough-8671.html Fri, 26 Jan 2018 13:30:00 +0000 https://www.proactiveinvestors.co.uk/companies/stocktube/8671/summit-therapeutics-hugely-excited-after-big-dmd-breakthrough-8671.html <![CDATA[Media files - Red letter day for Summit Therapeutics after positive interim ezutromid results ]]> https://www.proactiveinvestors.co.uk/companies/stocktube/8665/red-letter-day-for-summit-therapeutics-after-positive-interim-ezutromid-results-8665.html Thu, 25 Jan 2018 16:05:00 +0000 https://www.proactiveinvestors.co.uk/companies/stocktube/8665/red-letter-day-for-summit-therapeutics-after-positive-interim-ezutromid-results-8665.html <![CDATA[News - Summit Therapeutics shares jump on 'exciting' interim results of ezutromid study ]]> https://www.proactiveinvestors.co.uk/companies/news/190634/summit-therapeutics-shares-jump-on-exciting-interim-results-of-ezutromid-study-190634.html Shares in Summit Therapeutics PLC (LON:SUMM,NASDAQ:SMMT) shot higher today after it released encouraging data for its treatment for Duchenne Muscular Dystrophy (DMD).

The interim results for the PhaseOut study revealed a “statistically significant and meaningful” reduction in muscle damage in patients taking the company’s treatment, ezutromid.

READ: The release in detail WATCH: CEO Edwards hugely excited after DMD 'breakthrough'

"The significant reduction in muscle damage coupled with the increase in utrophin expression seen in PhaseOut DMD trial patients at 24 weeks is very encouraging as it suggests ezutromid may slow the relentless cycle of muscle fibre degeneration and regeneration that is a hallmark of DMD," said Professor Francesco Muntoni.

He is a director of the Dubowitz Neuromuscular Centre, at the UCL Institute of Child Health and Great Ormond Street Hospital for Children, London, UK, and the principal investigator in Summit Phase II clinical trial.

"These favourable interim results are certainly a step forward in the development of utrophin modulation as a treatment approach for this fatal disease in all patients with DMD," he added.

The headlines from the study ...  Treatment with ezutromid resulted in a statistically significant and meaningful reduction in muscle damage as measured by a 23% decrease in mean developmental myosin in muscle biopsies at 24 weeks compared to baseline (11.37% to 8.76%, 95% CI, -4.33, -0.90). Developmental myosin is a biomarker of muscle damage and is found in repairing fibres. A total of 14 of 22 patients showed a decrease in developmental myosin, with five of those showing a greater than 40% reduction. Increase in mean utrophin protein intensity levels of 7% in biopsies at 24 weeks compared to baseline (0.370 to 0.396, 95% CI, -0.005, 0.058).

Duchenne Muscular Dystrophy is a rare muscle-wasting disease that affects boys.

Summit’s research into the role of utrophin in DMD was based on the work of Dame Kay Davis, who made the link 30 years ago.

Dystrophin replacement

The protein is functionally and structurally similar to dystrophin, which is lacking in children with the disease.

Preclinical studies revealed the continued expression of utrophin had a meaningful, positive effect on muscle performance. The current trial appears to bear out the current findings.

The surprise is that its effects of ezutromid have been detected so early in the process. Investors will be updated next on the trial in the third-quarter, when PhaseOut hits the 48-week stage.

On the back of the interim data, the shares shot 21% higher to 215p, valuing Summitt at around £180mln.

Hugely excited 

The company’s chief executive, Glyn Edwards, on a conference call said he was “hugely excited by the data” as he announced plans to accelerate preparations for a pivotal clinical trial.

He said he wanted to “apply steroids” to the current plans to make them “bigger, better and faster”.

Analysts were taken through a presentation by David Roblin, the company’s chief medical officer. “This data set is strong and we are really pleased with it,” he said.

-- updates share price --

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Thu, 25 Jan 2018 12:15:00 +0000 https://www.proactiveinvestors.co.uk/companies/news/190634/summit-therapeutics-shares-jump-on-exciting-interim-results-of-ezutromid-study-190634.html
<![CDATA[News - Summit confirms £10mln acquisition of antibiotics discovery group Discuva ]]> https://www.proactiveinvestors.co.uk/companies/news/189284/summit-confirms-10mln-acquisition-of-antibiotics-discovery-group-discuva-189284.html Summit Therapeutics PLC (LON:SUMM) confirmed on Wednesday it has bought innovative antibiotic discovery and development firm Discuva in a cash-and-shares deal worth £10mln.

Discuva’s main asset is its genetics-based technology platform which Summit describes as a “powerful tool” in identifying new antibacterial drug candidates.

READ: Summit Therapeutics reports quarterly revenue growth as it makes progress with clinical trials

The platform has already “shown promise”, underlined by a research collaboration between Discuva and Swiss healthcare giant Roche.

Summit said the acquisition would position it as a leader in the research and development of new classes of antibiotics.

It will also enhance Summit’s broader business in rare and infectious diseases which is currently led by its flagship C. difficile antibiotic candidate, ridinilazole.

"The global threat from multi-drug resistant bacterial infections continues to rise,” said Summit chief executive Glyn Edwards.

“There are few new antibiotics in development, with most of those being iterations of known classes of antibiotics, meaning there is an urgent need for the development of novel antibiotics.

READ: Summit Therapeutics completes initial dosing of Duchenne muscular dystrophy treatment in trial

"With the acquisition, Summit is positioned as a leader in the research and development of new classes of antibiotics as exemplified by our precision antibiotic candidate ridinilazole for the treatment of C. difficile infection.

“Using this platform, we aim to generate a pipeline of new mechanism of action antibiotics that address other serious infectious disease threats."

Summit will pay £5mln in cash and another £5mln in shares to Discuva shareholders. Shares were issued at 170.4p - a 3.3% premium to Friday’s closing price - and Discuva shareholders must keep hold of them until at least next September.

Summit shares were down 3% to 160p early on Wednesday morning.

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Wed, 27 Dec 2017 08:28:00 +0000 https://www.proactiveinvestors.co.uk/companies/news/189284/summit-confirms-10mln-acquisition-of-antibiotics-discovery-group-discuva-189284.html
<![CDATA[RNS press release - Acquisition of Discuva Ltd ]]> https://www.proactiveinvestors.co.uk/companies/rns/962/LSE20171227070006_13476877/ Wed, 27 Dec 2017 07:00:06 +0000 https://www.proactiveinvestors.co.uk/companies/rns/962/LSE20171227070006_13476877/ <![CDATA[News - Summit Thereapeutics surges as it licenses the Latin American rights to its CDI candidate ]]> https://www.proactiveinvestors.co.uk/companies/news/189154/summit-thereapeutics-surges-as-it-licenses-the-latin-american-rights-to-its-cdi-candidate-189154.html Summit Therapeutics PLC (NASDAQ:SMMT, LON:SUMM) has farmed out the rights in Latin America to its in-development ridinilazole treatment for the C. difficile infection (CDI).

It has entered into an exclusive licence and commercialisation agreement granting Eurofarma Laboratórios SA rights in Latin America, while retaining commercialisation rights in all other countries.

READ: Summit Therapeutics reports quarterly revenue growth as it makes progress with clinical trials

Eurofarma is a multinational pharmaceutical company with headquarters in Brazil and operations in more than 20 countries in South and Central America, the Caribbean and Africa.

Summit will receive an upfront payment of US$2.5mln, and is entitled to receive a further US$3.75mln in development milestones upon the achievement of staged patient enrolment targets in the planned Phase 3 clinical trials of ridinilazole.

Summit is eligible to receive up to an additional US$21.4mln through other development milestones, commercial milestones, and one-time sales milestones based on cumulative net sales up to US$100mln in Latin America.

Further, the agreement provides for product supply transfer payments which are expected to provide a return the equivalent of a high single-digit to low double-digit percentage of net sales. For each incremental US$100mln in cumulative net sales achieved, Summit is entitled to a further milestone payment which, when combined with the aforementioned product supply transfer payments, is expected to provide a return equivalent to a mid- to high-teens percentage of net sales.

READ: Summit Therapeutics in a great position nearing the business end of its development

"Eurofarma's established infrastructure and expertise in Latin America are ideally placed to commercialise our novel antibiotic, ridinilazole," said Glyn Edwards, the chief executive officer of Summit.

"This agreement, combined with the recent contract award of up to $62 million from the US Government agency BARDA, will further support the Phase 3 clinical programme and regulatory development of ridinilazole. These partnerships endorse the potential of ridinilazole in the treatment of CDI, and move us a step closer to bringing this antibiotic to patients," he added.

Ridinilazole is a targeted antibiotic that has the potential as a frontline therapy to treat initial infection and preserve patients' microbiomes to reduce the rate of recurrent CDI.

In a Phase 2 proof of concept trial in CDI patients, ridinilazole demonstrated statistical superiority in sustained clinical response rates compared to the standard of care, vancomycin.

Ridinilazole is expected to enter Phase 3 clinical trials in the first half of 2018.

Shares in Summit rose 11% to 180p in early deals in London.

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Thu, 21 Dec 2017 08:33:00 +0000 https://www.proactiveinvestors.co.uk/companies/news/189154/summit-thereapeutics-surges-as-it-licenses-the-latin-american-rights-to-its-cdi-candidate-189154.html
<![CDATA[News - Summit Therapeutics reports quarterly revenue growth as it makes progress with clinical trials ]]> https://www.proactiveinvestors.co.uk/companies/news/188334/summit-therapeutics-reports-quarterly-revenue-growth-as-it-makes-progress-with-clinical-trials-188334.html Summit Therapeutics PLC (LON:SUMM; NASDAQ:SMMT) reported a jump in third quarter revenue and continued to see progress in clinical trials for its therapies for Duchenne muscular dystrophy (DMD) and Clostridium difficile infection (CDI).

In the three months ended 31 October, revenue rose to £1.7mln from £0.6mln the same period a year earlier, boosted by Summit’s exclusive licence and collaboration agreement with Sarepta Therapeutics.

The agreement grants Sarepta rights to Summit’s utrophin modulator pipeline, including its lead clinical candidate, ezutromid, for the treatment of DMD.

Summit recognised £1.7mln of the upfront payment of £32.8mln made by Sarepta in October last year.

The total comprehensive loss for the third quarter was £1.8mln as Summit continue to invest in advancing its therapies.

Phase 2 trial of ezutromid on track

Summit chief executive Glyn Edwards said the group remains on track to report 24-week data from its Phase 2 clinical trial of ezutromid for the treatment of DMD –  a severe type of muscular dystrophy-  in the first quarter of 2018.

DMD is one of the most common, fatal genetic disorders diagnosed in children around the world. It predominantly affects boys and it results in the progressive wasting of muscles throughout the body.

“Ezutromid is a potentially disease-modifying treatment for all patients with DMD and we look forward to reporting these initial data from this proof of concept trial,” Edwards said.

Positive results from ridinilazole trial

During the third quarter, the company also achieved another positive Phase 2 clinical trial result for ridinilazole, an antibiotic for the treatment of CDI - a bacterium that can infect the bowel and cause diarrhoea.

The company was awarded a contract worth up to US$62mln from the Biomedical Advanced Research and Development Authority (BARDA) in early September, which will help fund the Phase 3 clinical trial and regulatory development of ridinilazole.

“We are looking forward to initiating the Phase 3 clinical programme for ridinilazole in the first half of 2018 as we seek to bring this urgently needed treatment to patients,” said Edwards.

"The ongoing support of our shareholders is allowing us to continue to advance these two therapies that have the potential to enhance the quality of life of patients and families living with the burden of DMD and CDI."

Summit hosts DMD awareness day

The third quarter results were released alongside the group's announcement that it was teaming up with several other biopharmaceutical companies and charities to host a Duchenne Muscular Dystrophy awareness day in London today (Wednesday).

The half-day event was to feature presentations and speeches by key opinion leaders, industry professionals and patients.

The sponsoring companies - which include Santhera Pharmaceuticals and Catabasis Pharmaceuticals (NASDAQ:CATB) as well as Summit - were to update on their respective development programmes for new therapeutics options and the future outlook for patients.

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Wed, 06 Dec 2017 07:54:00 +0000 https://www.proactiveinvestors.co.uk/companies/news/188334/summit-therapeutics-reports-quarterly-revenue-growth-as-it-makes-progress-with-clinical-trials-188334.html
<![CDATA[News - Summit Therapeutics completes initial dosing of Duchenne muscular dystrophy treatment in trial ]]> https://www.proactiveinvestors.co.uk/companies/news/187517/summit-therapeutics-completes-initial-dosing-of-duchenne-muscular-dystrophy-treatment-in-trial-187517.html Summit Therapeutics PLC (LON:SUMM) (NASDAQ:SMMT) has completed the initial 24-weeks of dosing of ezutromid in patients with Duchenne muscular dystrophy (DMD) in a phase 2 clinical trial.

The drug discovery and development company expects to report results from the initial dosing period in the first quarter of 2018, putting it on track to conduct the planned biopsy, MRI and functional analyses.

The phase 2 trial, called PhaseOut DMD, is being carried out over 48 weeks and has enrolled 40 patients at sites in the UK and US.

Dr David Roblin, chief operating officer and medical officer of Summit, said: In the interim data readout, we aim to show a positive change following ezutromid treatment in muscle structure and health through the evaluation of muscle biopsies. This could potentially provide the first evidence of proof of mechanism for utrophin modulators in patients and give hope to those living with DMD."

The trial aims to establish proof of concept of ezutromid and is evaluating a range of muscle structure, muscle health and functional endpoints.

Each patient will have two muscle biopsies taken as part of the trial, including a baseline biopsy on enrolment and a second either after 24 weeks or 48 weeks of dosing. Top-line data from the complete 48-week trial are expected in the third quarter of 2018.

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Mon, 20 Nov 2017 13:48:00 +0000 https://www.proactiveinvestors.co.uk/companies/news/187517/summit-therapeutics-completes-initial-dosing-of-duchenne-muscular-dystrophy-treatment-in-trial-187517.html
<![CDATA[News - Summit Therapeutics to present pre-clinical data that reveals potential of DMD treatment ]]> https://www.proactiveinvestors.co.uk/companies/news/187025/summit-therapeutics-to-present-pre-clinical-data-that-reveals-potential-of-dmd-treatment-187025.html Drug discovery company Summit Therapeutics PLC (LON:SUMM) is set to present pre-clinical data from the University of Oxford highlighting the potential of its utrophin modulation programme in treating duchenne muscular dystrophy (DMD), a muscle wasting disease.

The company's scientific adviser and co-founder, Professor Kay Davies from the University of Oxford, will present the findings during presentations at the 15th Action Duchenne International Conference 2017 on November 10-12, 2017, in Birmingham, UK.

WATCH: Summit Therapeutics in a great position nearing the business end of its development

The data shows that continuously expressing utrophin in a dystrophin-deficient background can reduce mitochondrial aberration and oxidative stress, Summit said in a statement on Thursday.

Summit's own presentations will focus on the ongoing Phase II proof of concept clinical trial, PhaseOut DMD, which is evaluating its lead utrophin modulator, ezutromid.

PhaseOut DMD, a 48-week open-label clinical trial, has enrolled 40 patients with DMD.

The data for the first 24 weeks of the trial is expected to be reported in the first quarter of 2018 and Summit said this assessment could provide initial clinical proof of mechanism for ezutromid.

READ: Summit Therapeutics enters revenue sharing agreement with Wellcome Trust for ridinilazole

"We remain on-track to report the first results of ezutromid treatment in boys with DMD in PhaseOut DMD in the first quarter of 2018, and if results provide evidence of the mechanism of utrophin modulation in patients, we believe it would represent a major advancement for ezutromid,” said Dr David Roblin, chief operating officer and medical officer at Summit.

“It would bring closer to all patients a therapy that has the potential to be disease modifying in DMD."

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Thu, 09 Nov 2017 14:09:00 +0000 https://www.proactiveinvestors.co.uk/companies/news/187025/summit-therapeutics-to-present-pre-clinical-data-that-reveals-potential-of-dmd-treatment-187025.html
<![CDATA[Media files - Summit Therapeutics in a great position nearing the business end of its development ]]> https://www.proactiveinvestors.co.uk/companies/stocktube/8337/summit-therapeutics-in-a-great-position-nearing-the-business-end-of-its-development-8337.html Tue, 07 Nov 2017 12:32:00 +0000 https://www.proactiveinvestors.co.uk/companies/stocktube/8337/summit-therapeutics-in-a-great-position-nearing-the-business-end-of-its-development-8337.html <![CDATA[News - Summit Therapeutics enters revenue sharing agreement with Wellcome Trust for ridinilazole ]]> https://www.proactiveinvestors.co.uk/companies/news/186805/summit-therapeutics-enters-revenue-sharing-agreement-with-wellcome-trust-for-ridinilazole-186805.html Summit Therapeutics PLC (LON:SUMM, NASDAQ:SMMT)) has entered into a revenue sharing agreement with the Wellcome Trust for its ridinilazole drug for the treatment of clostridium difficile infection (CDI).

Under the agreement, the Wellcome Trust is eligible to receive a “mid-single digit percentage” share of net revenues received by Summit from the sales of ridinilazole if commercialisation of the drug is undertaken by a third-party.

READ: Summit Therapeutics given lift by appearance at infectious diseases conference

Wellcome Trust could also receive a one-time first commercial sale milestone payment of a “low single digit percentage” of any cumulative pre-commercial payments received by Summit from third party licensees. In addition, it would be eligible for a one-time milestone payment if cumulative net revenues exceed a specified amount.

If Summit undertakes the commercialisation of ridinilazole, Wellcome Trust will be able to claim a "low-single digit percentage" share of net revenues. The trust would also receive a one-time milestone payment if cumulative net revenues exceed a certain figure.  

The deal follows a translational award (TA) funding agreement with the Wellcome Trust in October 2012, which provided funds for the Phase 1 and II clinical trials of ridinilazole that have since been completed.

Phase III clinical trials are scheduled to begin in the first half of 2018, the company said in a statement on Monday.

READ: Summit Therapeutics chief keeps his eyes on two big prizes

The revenue sharing agreement will terminate the Wellcome Trust’s rights under the TA agreement to develop or commercialise ridinilazole or the associated intellectual property in the event that Summit was not able to do either.

"The Wellcome Trust has played a crucial role in supporting the development of our CDI programme, having provided funding to advance ridinilazole from the early stages of discovery through to generating clinical proof of concept in patients with CDI," said Dr David Roblin, chief operating officer and medical officer at Summit. 

"We believe ridinilazole is a precision antibiotic that has the potential to become a front-line therapy for CDI and to deliver real patient benefit. “

Ridinazole is an antibiotic for the treatment CDI, an infection that causes diarrhoea, nausea and abdominal pain.  

Shares added 4.86% to US$9.49 each.

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Mon, 06 Nov 2017 13:00:00 +0000 https://www.proactiveinvestors.co.uk/companies/news/186805/summit-therapeutics-enters-revenue-sharing-agreement-with-wellcome-trust-for-ridinilazole-186805.html
<![CDATA[News - Summit Therapeutics given lift by appearance at infectious diseases conference ]]> https://www.proactiveinvestors.co.uk/companies/news/185273/summit-therapeutics-given-lift-by-appearance-at-infectious-diseases-conference-185273.html Shares in Summit Therapeutics PLC (NASDAQ:SMMT, LON:SUMM) perked up in London trading after the company presented at ID Week 2017, the conference on infectious diseases.

The dual-listed company, which is advancing therapies for Duchenne muscular dystrophy (DMD) and Clostridium difficile infection (CDI), presented further positive gut microbiome data of ridinilazole from its exploratory Phase 2 clinical trial.

The emphasis was on microbiome preservation during treatment with ridinilazole, a small molecule antibiotic that the Oxford-based company is developing for the treatment of CDI.

In comparison with fidaxomicin, an established treatment for CDI, both drugs reduced the abundance of bacteria from the C. difficile and a closely related family, but fidaxomicin also reduce the abundance of other bacterial families, including reductions to bacteria belonging to the Firmicutes phylum that are thought to have direct functional roles in protecting against CDI.

Another important measure of microbiome health is alpha-diversity, Summit noted. In this measure, ridinilazole treatment resulted in no loss in median alpha diversity, whereas fidaxomicin treatment was associated with loss of alpha diversity during dosing.

"The impressive level of microbiome detail afforded by our clinical analyses shows the low impact of ridinilazole treatment on the gut microbiomes of patients while they are being treated for CDI," said Dr David Roblin, chief medical and operating officer of Summit.

"We believe ridinilazole is a precision antibiotic that combines low impact on the gut microbiome with high potency in killing C. difficile and that, with this profile, and its consequent potential to reduce recurrent disease, it could become a future front-line treatment option in CDI."

Shares in Summit were up 5.7% at 200.8p in lunchtime trading in London.

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Mon, 09 Oct 2017 13:42:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/185273/summit-therapeutics-given-lift-by-appearance-at-infectious-diseases-conference-185273.html
<![CDATA[News - Summit Therapeutics shares DMD data ]]> https://www.proactiveinvestors.co.uk/companies/news/185050/summit-therapeutics-shares-dmd-data-185050.html Summit Therapeutics PLC (LON:SUMM, NASDAQ:SMMT) said it and its collaboration partners will be presenting information related to its phase II clinical trial.

One poster at an industry conference this week will include validation data of muscle biopsy biomarkers used to assess utrophin modulator activity.

Utrophin control is central to Summit drug ezutromid, which is a potential treatment for boys with the incurable muscle wasting disease, Duchenne Muscular Dystrophy (DMD).

Flagship collaboration 

The biomarker breakthrough has come out of Summit’s collaboration with Flagship Biosciences.

"Developing new biomarkers capable of more reliably analysing muscle biopsies in clinical trials has been a major priority for Summit, and I am delighted with the progress made in our collaboration with Flagship,” said Dr David Roblin, the company’s chief medical officer.

“These automated techniques are capable of analysing thousands of muscle fibres in whole muscle biopsy sections, and we believe that their use could help us establish proof of mechanism for our utrophin modulator, ezutromid, in our ongoing PhaseOut DMD clinical trial."

The AIM and NASDAQ-listed life sciences company will also share baseline characteristics of patients enrolled into Summit's ongoing PhaseOut DMD study.

The conference, the 22nd International Congress of the World Muscle Society, is currently taking place in Saint-Malo, France.

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Wed, 04 Oct 2017 12:56:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/185050/summit-therapeutics-shares-dmd-data-185050.html
<![CDATA[News - Summit teams up with cTAP as it looks to accelerate development of its DMD drug ]]> https://www.proactiveinvestors.co.uk/companies/news/184520/summit-teams-up-with-ctap-as-it-looks-to-accelerate-development-of-its-dmd-drug-184520.html Drug discoverer Summit Therapeutics PLC (LON:SUMM; NASDAQ:SMMT) has teamed up with the Collaborative Trajectory Analysis Project to try and accelerate the development of its lead Duchenne muscular dystrophy candidate.

Summit’s utrophin modulator for the treatment of DMD – ezutromid – is currently in a phase II clinical trial, with data from the 48-week study expected in the third quarter of 2018.

But the dual-listed firm hopes that by partnering with cTAP, it can potentially adapt and improve the overall clinical process.

“In the Duchenne field, there is a strong community amongst the families, patient organisations, caregivers and industry that comes together to improve the lives of patients living with this disease, where time is of the essence,” said Dr David Roblin, President of R&D of Summit.

“cTAP is leveraging the natural history and clinical data collected within this community to create more predictive models of disease progression with the aim of enabling companies to interpret data and improve the design of clinical trials in DMD.

“We believe this could potentially benefit the development of our utrophin modulators for the treatment of all patients with DMD.”

Roblin added that Summit would also be able to contribute its own data to the project.

In late afternoon trading, Summit shares were up 1.3%, or 2.5p at 197.5p.

 -- Updates share price --

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Mon, 25 Sep 2017 13:37:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/184520/summit-teams-up-with-ctap-as-it-looks-to-accelerate-development-of-its-dmd-drug-184520.html
<![CDATA[News - Summit Therapeutics chief keeps his eyes on two big prizes ]]> https://www.proactiveinvestors.co.uk/companies/news/184010/summit-therapeutics-chief-keeps-his-eyes-on-two-big-prizes-184010.html It is almost five years to the day Proactive first spoke to Glyn Edwards following his appointment as chief executive of a company called Summit Corporation, known today as Summit Therapeutics PLC (LON:SUM, NASDAQ:SMMT).

In that time a lot more has changed than just the name. Setting out his stall in 2012, the Summit CEO took the decision to jettison discovery-stage research to focus on just two drug candidates.

They were C1100 for Duchenne Muscular Dystrophy, a rare muscle wasting disease that affects boys, and SMT 19969, a next-generation antibiotic.

Progress

Today, C1100 has morphed into Ezutromid, which is undergoing Phase II clinical trials with US biotech Sarepta as partner and funder. It also has fast-track designation from the US Food & Drug Administration (FDA).

Ready to enter final-stage trials, SMT 19969 is the most advanced of the two drugs and is now known as Ridinilazole.

It is thought to be effective against multiple different strains of the difficult-to-treat infection c.difficile (CDI).

It is also believed to be superior to existing medications, such as vancomycin and metronidazole. 

Eye-catching

What’s eye-catching about Summit’s progress has been its ability to raise money at crucial junctures of its development – something British companies of Summit’s size and ilk have often failed to do.

On Thursday it unveiled a fully underwritten US share issue that will bring in up to US$20mln of new cash, landing in the process Lansdowne Partners, one of Europe’s longest-established hedge funds, as a cornerstone investor.

READ: Summit Therapeutics' US fundraiser should secure drug developer's long-term financial future

This would be quite impressive were it not for the fact Summit has secured funding commitments of up to US$62mln from a US government agency called BARDA (that stands for the Biomedical Advanced Research and Development Authority) to support work on Ridinilazole.

Summit’s partner, Sarepta, meanwhile, ‘ponied up’ US$22mln in May as part of a milestone and royalties deal worth more than half a billion dollars.

There are two observations to make at this stage: first, Edwards and his team have negotiated firm funding and commitments worth more than US$100mln this year alone.

The second point relates directly to the US$522mln Sarepta agreement. Summit’s market cap is roughly half that figure, which means the American giant might be better off bidding for its smaller rival than paying up the contract in full.

Building on early promise

That, of course, relies on Ezutromid building on its early promise.

The treatment recently completed enrolment for its PhaseOut Phase II clinical trial, which triggered the payment from partner Sarepta.

READ: Summit Therapeutics antibiotic delivers encouraging clinical trial results

The study recruited 40 patients in the US and UK and will take 48 weeks to complete.

Researchers will assess how it affects muscle structure, health and function.

Data from the half-way stage is expected in the first quarter of next year with the trial set to close in the third quarter.

Duchenne Muscular Dystrophy, or DMD, is one of the most common, fatal genetic disorders diagnosed in children around the world.

Unmet medical need

It predominantly affects boys and it results in the progressive wasting of muscles throughout the body.

The disease has an estimated incidence of 1 in 5,000 and a patient population in the developed world of around 50,000. Patients typically don’t live beyond their late 20s.

It is caused by different genetic faults in the gene that encodes dystrophin, a protein that is essential for the healthy function of all muscles.

Utrophin protein is functionally and structurally similar to dystrophin and in preclinical studies the continued expression of utrophin had a meaningful, positive effect on muscle performance.

Talking recently about the Ezutromid clinical trial, corporate affairs director Richard Pye said: “We are very excited by our approach.

50,000 affected worldwide

“We estimate there are around 50,000 boys and young men suffering this condition [worldwide].

“It is a relatively small patient population, but what you can get with orphan drugs is premium pricing.

“So we can see this being a multi-billion dollar market if you have a drug that is shown to be effective. That’s what we are wanting to establish with our phase II trial – the potential clinical benefit of our approach.

“We can see this really making a difference to the boys and young men living with this condition, because currently there is no approved treatment that would benefit all the patients. There is a huge unmet medical need here.”

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Thu, 14 Sep 2017 14:12:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/184010/summit-therapeutics-chief-keeps-his-eyes-on-two-big-prizes-184010.html
<![CDATA[News - Summit Therapeutics' US fundraiser should secure drug developer's long-term financial future ]]> https://www.proactiveinvestors.co.uk/companies/news/183961/summit-therapeutics-us-fundraiser-should-secure-drug-developer-s-long-term-financial-future-183961.html Drug developer Summit Therapeutics PLC (LON:SMMT) will effectively secure its financial future with a fully underwritten issue of stock that could bring in as much as US$20mln.

The AIM-listed firm, which is also quoted on the NASDAQ exchange, is issuing 1.459mln new American depositary shares at US$12 each, bringing in a minimum of US$17.5mln.

A further 218,850 units are available to meet excess demand, which would take the total to US$20.1mln.

Canaccord Genuity and JMP Securities are leading the American fundraiser, while Lansdowne Partners, one of Europe’s largest hedge funds, has come in as a cornerstone investor.

US funding boost

The injection of investor cash follows news last week Summit had secured a funding package of US$62mln from US authorities to bankroll the development of its next-generation antibiotic, Ridinilazole. 

READ: Summit Therapeutics soars after securing funding from US government agency

Earlier this year it received a US$22mln milestone payment from the US biotech Sarepta related the progress of Ezutromid, its treatment for Duchenne Muscular Dystrophy (DMD), a rare muscle-wasting disease that affects boys.

Ezutromid recently completed enrolment for its PhaseOut phase II clinical trial, which triggered the payment from partner Sarepta.

Study underway

The study recruited 40 patients in the US and UK and will take 48 weeks to complete.

Researchers will assess how it affects muscle structure, health and function.

Data from the half-way stage is expected in the first quarter of next year with the trial set to close in the third quarter.

Blockbuster potential

Ridinilazole, meanwhile, could be a blockbuster for the company as well as providing a breakthrough against antibiotic resistance.

READ: Summit Therapeutics antibiotic delivers encouraging clinical trial results

It is thought to be effective against multiple different strains of the difficult-to-treat infection c.difficile (CDI).

It is also believed to be superior to existing medications such as vancomycin and metronidazole.

“We believe ridinilazole can become a new, urgently needed frontline therapy for this serious infectious disease,” said chief executive Glyn Edwards said recently

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Thu, 14 Sep 2017 07:36:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/183961/summit-therapeutics-us-fundraiser-should-secure-drug-developer-s-long-term-financial-future-183961.html
<![CDATA[News - Summit Therapeutics soars after securing funding from US government agency ]]> https://www.proactiveinvestors.co.uk/companies/news/183758/summit-therapeutics-soars-after-securing-funding-from-us-government-agency-183758.html Drug discovery and development company Summit Therapeutics PLC (LON:SUMM, NASDAQ:SMMT) has secured up to US$62mln of funding from the US government.

The Biomedical Advanced Research and Development Authority (BARDA), an agency of the US government's Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response, awarded the contract to support the clinical and regulatory development of ridinilazole for the treatment of the C. difficile infection (CDI), including Summit's planned Phase 3 development programme.

We've been awarded a grant from BARDA worth up to $62M to support development of ridinilazole in #cdiff https://t.co/Q5W85vn5xt

— Summit Therapeutics (@Summitplc) September 11, 2017

Ridinilazole is a highly selective, novel class antibiotic aimed at both treating the initial infection and reducing recurrent disease, which is the key clinical issue in the treatment of CDI, Summit said.

In a Phase 2 proof of concept clinical trial conducted in North America, ridinilazole was shown to be highly preserving of the microbiome of patients compared with the standard of care, vancomycin, and achieved a substantial reduction in rates of recurrent disease.

The Centers for Disease Control and Prevention highlighted C. difficile as one of three pathogens that pose an immediate public health threat. The economic impact of CDI is significant with one study estimating annual acute care costs at US$4.8bn in the USA alone.

BARDA will fund a specified portion of estimated costs for particular activities related to the continued clinical and regulatory development of ridinilazole for CDI.

Initially, it will stump up US$32mln to partly finance the journey towards regulatory approval, including enrolment and dosing programmes in two planned Phase 3 clinical trials of the drug.

In addition, Summit is eligible for additional funding under the contract pursuant to three independent option work segments, which may be exercised by BARDA in its sole discretion upon the achievement of certain development and other milestones for ridinilazole.

If the three option work segments are exercised in full, Summit would be eligible for an additional US$30mln from BARDA.

"CDI is a serious public health threat that is a significant burden on the US population, and BARDA has committed to the development of innovative treatments capable of addressing all aspects of this serious illness, including recurrent disease,” said Glyn Edwards, chief executive officer of Summit.

“BARDA's selection of ridinilazole for an award is testament to ridinilazole's promising clinical and preclinical data package that indicate its potential as a front-line treatment of CDI that could reduce recurrent disease," he added.

Summit announced at the end of last month that it was considering funding options for a CDI trial, raising the possibility of a dilutive share issue, but today’s announcement appears to have allayed those fears, though Summit said it continues to explore various funding options for completion of its Phase 3 clinical development programme, with these options including entering into a collaboration with a third party, equity financing or securing additional non-dilutive funding from government entities and philanthropic, non-government and not for profit organizations.

READ Summit Therapeutics DMD trial underway; mulls funding options for c. diff trial

"This non-dilutive funding award begins to deliver on our strategy of maximizing the value of ridinilazole for patients with CDI, Summit and our shareholders, and we look forward to initiating the Phase 3 clinical programme of ridinilazole," Edwards said.

The shares of Summit were up 20% at 246.67p in London trading.

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Mon, 11 Sep 2017 13:02:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/183758/summit-therapeutics-soars-after-securing-funding-from-us-government-agency-183758.html
<![CDATA[News - Summit Therapeutics antibiotic delivers encouraging clinical trial results ]]> https://www.proactiveinvestors.co.uk/companies/news/183458/summit-therapeutics-antibiotic-delivers-encouraging-clinical-trial-results-183458.html Summit Therapeutics PLC’s (LON:SUMM, NASDAQ:SMMT) next-generation antibiotic scored well in a head to head with the existing treatment for Clostridium difficile infection (C.difficile).

A Phase II clinical trial pitched Summit’s ridinilazole against a specialist (narrow-spectrum) drug, fidaxomicin.

The data revealed that both reduced the abundance of C.difficile.

However, ridinilazole had “markedly less” impact on the gut microbiome.

READ: Summit Therapeutics DMD trial underway; mulls funding options for c.diff trial Body's ecosystem

The ecosystem of the gut is part of the human microbiome, which also exists on the skin.

It is thought to be key to regulating the body’s function, the way it digests food, vitamins and medicines and how it repels infection and disease.

Summit chief medical officer Dr David Roblin said in a statement: "Ridinilazole is a precision antibiotic that is designed to selectively target C.difficile while being highly preserving of the gut microbiome that plays a crucial role in naturally protecting against recurrent CDI.

Highly selective

“Ridinilazole has now provided evidence of its high selectivity in two complementary clinical trials.

“The data from our earlier phase II trial showed a greater microbiome preservation of ridinilazole-treated patients compared with the current standard of care, vancomycin, which led to achieving statistical superiority in sustained clinical response.”

The latest study is a different one from the Phase III trial of ridinilazole currently underway and is expected to yield early data in the first half of next year. It gave limited pointers on efficacy compared with fidaxomicin.

An earlier Phase II trial, which pitched ridinilazole against vancomycin, delivered impressive results.

The shares rose 7% to to 207.5p.

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Tue, 05 Sep 2017 12:43:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/183458/summit-therapeutics-antibiotic-delivers-encouraging-clinical-trial-results-183458.html
<![CDATA[News - Summit Therapeutics DMD trial underway; mulls funding options for c.diff trial ]]> https://www.proactiveinvestors.co.uk/companies/news/183245/summit-therapeutics-dmd-trial-underway-mulls-funding-options-for-cdiff-trial-183245.html Summit Therapeutics PLC’s (LON:SUMM, NASDAQ:SMMT) interim results statement charted a period of significant progress for its two main drug candidates.

It is developing Ezutromid for Duchenne muscular dystrophy (DMD), a rare muscle wasting disease that affects boys, and Ridinilazole, a next-generation antibiotic.

The former has completed enrolment for its PhaseOut phase II clinical trial, which triggered a £17.2mln milestone payment from partner Sarepta, the US group.

Study underway 

The study recruited 40 patients in the US and UK and will take 48 weeks to complete.

Researchers will assess how Ezutromid affects muscle structure, health and function.

Data from the half-way stage is expected in the first quarter of next year with the trial set to close in the third quarter.

Funding options

In the update, Summit said it was “exploring various funding options” for Ridinilazole, which is thought to be effective against multiple different strains of the difficult-to-treat infection c.difficile (CDI).

It may seek a partnership or “non-dilutive funding” such as a government grant or philanthropic contribution ahead of phase III trials in the first half of next year.

It is also believed to be superior to existing medications such as vancomycin and metronidazole.

“We believe ridinilazole can become a new, urgently needed frontline therapy for this serious infectious disease,” said chief executive Glyn Edwards.

Sarepta boost

The company’s figures showed it was sitting on £28.1mln at the end July following receipt of the Sarepta payment.

As well as boosting the bank balance, the income meant Summit was able to post a profit of £6.2mln for the six months to July 31, which compared with an £11.9mln loss for the same period last year.

Research and development expenses were £11.6mln.

Edwards was upbeat on the prospects for Summit.

"We look forward to an exciting and important period ahead as we continue advancing these two assets that have the potential to improve the quality of life of patients and families living with DMD and CDI," he said.

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Thu, 31 Aug 2017 12:25:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/183245/summit-therapeutics-dmd-trial-underway-mulls-funding-options-for-cdiff-trial-183245.html
<![CDATA[News - Summit Therapeutics presents first data from reformulated DMD treatment ]]> https://www.proactiveinvestors.co.uk/companies/news/179699/summit-therapeutics-presents-first-data-from-reformulated-dmd-treatment-179699.html Summit Therapeutics PLC (NASDAQ: SMMT LON:SUMM) has presented first clinical data for an upgraded version of ezutromid, its lead utrophin modulator, at the European Paediatric Neurology Society Congress in Lyon.

Summit wants to improve absorption of ezutromid in patients with duchenne muscular dystrophy (DMD) through a modified diet and new formulation.

"Our Phase 1 clinical development programme has identified ways to improve the pharmacokinetic profile of ezutromid.

 Through both formulation development and dietary advice, ezutromid achieves exposures which we believe have the potential to sustain utrophin production in patients with DMD," said David Roblin, Summit’s president of R&D. 

"We are now utilising both methods in our ongoing Phase 2 clinical trial, PhaseOut DMD, where we have the chance to see the impact of ezutromid drug exposure on pharmacology, safety and efficacy with longer term dosing of patients with DMD."

Duchenne Muscular Dystrophy, or DMD, is one of the most common, fatal genetic disorders diagnosed in children around the world.

It predominantly affects boys and it results in the progressive wasting of muscles throughout the body.

The disease has an estimated incidence of 1 in 5,000 and a patient population in the developed world of around 50,000. Patients typically don’t live beyond their late 20s.

It is caused by different genetic faults in the gene that encodes dystrophin, a protein that is essential for the healthy function of all muscles.

Utrophin protein is functionally and structurally similar to dystrophin and in preclinical studies the continued expression of utrophin had a meaningful, positive effect on muscle performance.

 

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Thu, 22 Jun 2017 15:46:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/179699/summit-therapeutics-presents-first-data-from-reformulated-dmd-treatment-179699.html
<![CDATA[News - Summit Therapeutics boss to speak at DMD conference ]]> https://www.proactiveinvestors.co.uk/companies/news/179331/summit-therapeutics-boss-to-speak-at-dmd-conference-179331.html Glyn Edwards, chief executive officer of Summit Therapeutics PLC (LON:SUMM, NASDAQ:SMMT), is to speak at a New York life sciences conference this month.

The boss of the dual-listed drug discovery and development company, which is focused on advancing therapies for Duchenne muscular dystrophy (DMD) and Clostridium difficile infection, will participate in a DMD pipeline panel discussion at the JMP Securities Life Sciences Conference on 21 June 2017.

Edwards will also participate in one-to-one meetings at the conference. 

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Thu, 15 Jun 2017 09:27:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/179331/summit-therapeutics-boss-to-speak-at-dmd-conference-179331.html
<![CDATA[News - Summit Therapeutics sees first quarter loss narrow after revenue boost from its first milestone payment ]]> https://www.proactiveinvestors.co.uk/companies/news/179245/summit-therapeutics-sees-first-quarter-loss-narrow-after-revenue-boost-from-its-first-milestone-payment-179245.html Summit Therapeutics PLC (LON:SUMM) saw its first quarter loss narrow year-on-year as it got a revenue boost from its first milestone payment, with the group looking for more funding for clinical trials.

For the three months to April 30, the biotech firm reported a pre-tax loss of £5.96mln, down from last year’s £6.37mln loss, on revenue of £1.72mln, compared to nil in the prior year.

The revenue came from its milestone payment from Sarepta Therapeutics Inc, after enrolment was completed for a phase II proof of concept trial for the drug ezutromid in patients with Duchenne muscular dystrophy, as announced in May.

WATCH: Summit Therapeutics ‘keeping up drug development pace’ following $22mln milestone payment

The group said a further £28.8mln of the Sarepta payment will be recognised over the treatment's development period.

Summitt’s chief executive, Glyn Edwards said: “We have made provisions for patients in the trial to remain on ezutromid beyond the initial 48-weeks of the trial, which will allow us to monitor safety and efficacy data related to longer-term dosing.

“We look forward to reporting 24-week biopsy, MRI and functional data in the first quarter of 2018 for what could be the first disease modifying treatment for all patients with DMD.”

Preparing phase III development programme for its antibiotic

Additionally, the company said it is preparing a phase III development programme for its antibiotic product ridinilazole, with trials planned to start in the first half of 2018.

Summit is exploring funding options for the programme, including third-party collaboration and government funding.

As of April 30, the firm had cash of £19.4mln, compared to £28.1mln as at January 31.

Summit shares held steady at 172.5p in mid-afternoon trading.

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Wed, 14 Jun 2017 14:11:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/179245/summit-therapeutics-sees-first-quarter-loss-narrow-after-revenue-boost-from-its-first-milestone-payment-179245.html
<![CDATA[News - Summit Therapeutics says new data on selective antibiotic shows potency for treatment of clostridium difficile infection ]]> https://www.proactiveinvestors.co.uk/companies/news/178783/summit-therapeutics-says-new-data-on-selective-antibiotic-shows-potency-for-treatment-of-clostridium-difficile-infection-178783.html Summit Therapeutics PLC (LON:SUMM) (NASDAQ:SMMT) saw its shares jump 4% after the drug developer said new preclinical data on ridinilazole, a novel and selective antibiotic for the treatment of clostridium difficile infection (CDI), had been presented at ASM Microbe 2017 in New Orleans.

The AIM and Nasdaq-listed firm said the results, presented in two poster presentations at the US conference over the first five days of June, showed that ridinilazole was very active against all CDI isolates with overall minimum inhibition concentrations distributed over a very narrow range.

READ: Summit Therapeutics strengthens R&D team

David Roblin, Summit’s president of research & development, said: "These positive preclinical data presented at ASM Microbe highlight the potency of ridinilazole against a wide range of CDI clinical isolates from patients with CDI.”

He added: "Combining potency and selectivity, ridinilazole has shown positive results in clinical trials that support its potential to treat patients with CDI and reduce the rate of recurrent disease.

“It is thought that the preservation and restoration of the patient microbiome is important in reducing recurrence and ridinilazole's narrow spectrum is designed to achieve this.

“We believe ridinilazole has the potential to be a novel, and urgently needed, front-line treatment option for this serious disease.”

In early afternoon trading Summit shares were 4.1%, or 7.5p higher at 182.5p.

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Mon, 05 Jun 2017 13:39:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/178783/summit-therapeutics-says-new-data-on-selective-antibiotic-shows-potency-for-treatment-of-clostridium-difficile-infection-178783.html
<![CDATA[News - Summit Therapeutics strengthens R&D team ]]> https://www.proactiveinvestors.co.uk/companies/news/178203/summit-therapeutics-strengthens-rd-team-178203.html Summit Therapeutics PLC (LON:SUMM, NASDAQ:SMMT) has announced three senior appointments to strengthen its research and development (R&D) team.

The company, which is advancing therapies for Duchenne muscular dystrophy (DMD) and Clostridium difficile infection (CDI), said Dr David Roblin will expand his role to become chief medical officer, and will assume full operational leadership for Summit’s R&D efforts.

He replaces Dr Ralf Rosskamp, who has resigned.

Glyn Edwards, chief executive officer of Summit, said Rosskamp had played an important role in supporting the development of Summit’s DMD and CDI clinical programmes, both of which have achieved significant clinical milestones during his time with us.

Dr Roblin is also chief operating officer and president of R&D.

Summit has also appointed Anne Heatherington, PhD, as head of Clinical Development and Quantitative Sciences and Dave Powell, PhD, as head of Research.

Dr Heatherington joined Summit from Pfizer and has already taken up her role in the company's office in Cambridge, Massachusetts, US, while Dr Powell will join Summit in late June from GlaxoSmithKline and will be based at the company's headquarters in Oxfordshire, UK.

"This strengthening of our research and development team will help to ensure the organisation has the leadership, depth of knowledge and expertise needed to support ezutromid and ridinilazole as they enter crucial stages in their clinical evaluation and support progression of our earlier stage utrophin development pipeline," Edwards said.

"David Roblin brings the experience gained through a successful 25 years in the biopharmaceutical industry, and we are delighted he is adding to his existing roles.

“Anne Heatherington brings a wealth of experience across all aspects of clinical development, while Dave Powell's skills in discovery research and leading collaborative research programmes between industry and academia will support our strategic alliance with the University of Oxford,” the CEO added.

Summit’s shares were up 2.5% at the end of the lunchtime trading session in London.

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Tue, 23 May 2017 14:10:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/178203/summit-therapeutics-strengthens-rd-team-178203.html
<![CDATA[Media files - Summit Therapeutics ‘keeping up drug development pace’ following $22mln milestone payment ]]> https://www.proactiveinvestors.co.uk/companies/stocktube/7464/summit-therapeutics-keeping-up-drug-development-pace-following-22mln-milestone-payment-7464.html Tue, 16 May 2017 11:41:00 +0100 https://www.proactiveinvestors.co.uk/companies/stocktube/7464/summit-therapeutics-keeping-up-drug-development-pace-following-22mln-milestone-payment-7464.html <![CDATA[News - Summit Therapeutics to receive US$22mln milestone payment as final patient enrols for DMD trial ]]> https://www.proactiveinvestors.co.uk/companies/news/177800/summit-therapeutics-to-receive-us22mln-milestone-payment-as-final-patient-enrols-for-dmd-trial-177800.html Summit Therapeutics PLC (NASDAQ:SMMT LON:SUMM) will receive a US$22mln milestone payment from Sarepta Therapeutics (NASDAQ:SRPT) after the final patient was enrolled in a dosing trial of utrophin modulator, ezutromid.

Summit hopes the trial will identify utrophin modulation as a potential disease-modifying treatment for all patients suffering Duchenne Muscular Dystrophy (DMD),  a progressive and fatal muscle wasting disease that affects 50,000 boys and young men globally.

The endpoints for PhaseOut DMD, a phase II trial of ezutromid, are muscle structure, health and function improvements.

Dosing of the last patient  triggered a US$22mln payment for Summit through its licence and collaboration agreement with Sarepta (NASDAQ:SRPT). 

David Roblin, chief operating officer and Summit’s president of R&D said: "Utrophin modulation has potential as a universal treatment option for patients with DMD, and we look forward to the 24-week data readout expected in the first quarter of 2018."

The PhaseOut DMD will monitor 40 patients at sites in the UK and the US and take 48-weeks overall to complete.

As part of the trial, each patient undergoes two biopsies, a baseline biopsy on enrolment and a second either at 24 or 48 weeks.

In the first quarter of 2018, Summit expects to report 24-week biopsy analysis from approximately 20 patients, as well as 24-week MRI and functional data from all 40 patients enrolled in the trial.

Top-line data from the complete 48-week trial is expected in the third quarter of 2018.

Shares in Summit rose by 5% to 187p.

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Mon, 15 May 2017 12:59:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/177800/summit-therapeutics-to-receive-us22mln-milestone-payment-as-final-patient-enrols-for-dmd-trial-177800.html