Proactiveinvestors United Kingdom Summit Therapeutics PLC https://www.proactiveinvestors.co.uk Proactiveinvestors United Kingdom Summit Therapeutics PLC RSS feed en Sat, 20 Apr 2019 09:22:38 +0100 http://blogs.law.harvard.edu/tech/rss Genera CMS action@proactiveinvestors.com (Proactiveinvestors) action@proactiveinvestors.com (Proactiveinvestors) <![CDATA[News - Summit Therapeutics well placed in the race to find next-generation antibiotic ]]> https://www.proactiveinvestors.co.uk/companies/news/218703/summit-therapeutics-well-placed-in-the-race-to-find-next-generation-antibiotic-218703.html It is developing new-mechanism antibiotics for the treatment of serious infections. The market for these drugs is potentially huge, given the growing resistance to current treatments. Next-generation drugs are at a premium. The US, for example, last approved a new mode of action antibiotic in 2003.

Against this backdrop, Summit is nurturing its flagship drug Ridinilazole through the clinical trial process. Ridinilazole was created specifically to tackle C.difficile, one of the most common bacteria, and works to kill its target by stopping cell division.

Having successfully navigated a Phase II assessment of its potential, the Summit product has advanced to a final-stage studies. These are designed to support the right label for treating CDI and reducing recurrences.

But to do so, the Phase III trials, which kicked off in February, will have to show superiority over the standard of care, an antibiotic called vancomycin.

Using its Discuva Platform, Summit has also identified two novel targets to kill the gonorrhoeae bacteria. Its lead candidate from this stable is SMT-571.

Inflexion Points

Arguably one value kicker potentially not fully understood by the market was the US$25mln investment by US billionaire Bob Duggan, who in December agreed to take a 48.8% stake in the company.  At this point, the market was assimilating the fallout from the failure of the most advanced drug in Summit’s portfolio, Ezutromid. Some experts would argue Duggan got a bargain (see Blue Sky section).

Possibly also not particularly well understood is the fact that the ongoing clinical and regulatory development of Ridinilazole is being supported by a contract from the US Biomedical Advanced Research and Development Authority (BARDA). This potentially provides up to US$62mln of funding, with US$44mln under contract, including a $12mln option that was exercised by BARDA last August.

On the clinical trial front, top-line data isn’t expected until the second half of 2021 – so this is a something of a slow burner.

Blue Sky

In February, boutique investment house Bryan Garnier & Co initiated coverage on Summit with a 155p a share price target. This year so far, the stock has traded no higher than 33p.

What piqued BG’s interest? Well, the new mechanism driving Ridinilazole. A note from the French house read: “In this era of growing threats to health and medical practice coming from ever more resistant super strains of antibioticresistant bacterial, it is timely that Summit Therapeutics is driving new mechanism antibiotics into clinical development.”

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Tue, 16 Apr 2019 14:49:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/218703/summit-therapeutics-well-placed-in-the-race-to-find-next-generation-antibiotic-218703.html
<![CDATA[News - Summit Therapeutics soars as it hails potential of very early stage antibiotic ]]> https://www.proactiveinvestors.co.uk/companies/news/218551/summit-therapeutics-soars-as-it-hails-potential-of-very-early-stage-antibiotic-218551.html Summit Therapeutics PLC (NASDAQ:SMMT) (LON:SUMM) shares soared higher on Monday as the firm trumpeted the early success of a pre-clinical antibiotic that may help overcome drug resistance to a potentially deadly infection.

The group said it presented data at a leading healthcare conference that showed its treatment, DDS-04, had successfully tackled bacteria called Enterobacteriaceae in animals with urinary tract infections.

Resistant strain

Antimicrobial resistance means people contracting the gram-negative bacterial strain, which also affects the lungs and bloodstream, “are increasingly at risk for poor outcomes”, said Dr David Roblin, Summit’s head of research and development.

“Mainstay treatments are losing their effectiveness, and patients do not have the luxury of time to fail antibiotic therapy,” he explained. “There is a pressing need for new, targeted Enterobacteriaceae antibiotics that can serve to improve patient outcomes.”

The data were presented at the European Congress of Clinical Microbiology & Infectious Diseases, taking place in Amsterdam.

In early afternoon trading in London, Summit shares were 17.3% higher at 32.25p.

 -- Adds share price --

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Mon, 15 Apr 2019 07:27:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/218551/summit-therapeutics-soars-as-it-hails-potential-of-very-early-stage-antibiotic-218551.html
<![CDATA[News - Summit Therapeutics expands drug pipeline with antibiotics targeting deadly bacteria ]]> https://www.proactiveinvestors.co.uk/companies/news/217864/summit-therapeutics-expands-drug-pipeline-with-antibiotics-targeting-deadly-bacteria-217864.html Summit Therapeutics PLC (LON:SUMM) is set to expand its drug portfolio with a new antibiotics series designed to fight bacteria responsible for infections of the bloodstream, lungs and urinary tract.

The company plans to present data on the series of new mechanism antibiotics, called DDS-04, at the 29th European Congress of Clinical Microbiology & Infectious Diseases in Amsterdam on April 13-16.

READ: Summit Therapeutics well backed for next phase of development

The DDS-04 series targets Enterobacteriaceae, a family of Gram-negative bacteria that includes Klebsiella pneumoniae and Escherichia coli, which can cause severe and often deadly infections.

Summit said DDS-04 has shown activity across a panel of K.pneumoniae and E. coli strains, including strains resistant to the antibiotics currently available. 

“The DDS-04 series provides us with a major opportunity to improve patient outcomes across several body sites where Enterobacteriaceae cause infection,” said Dr David Roblin, president of research and development of Summit. 

“We look forward to developing the programme to show compelling clinical and economic data that offer significant advantages over standard of care for the patients in need.”

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Wed, 03 Apr 2019 12:22:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/217864/summit-therapeutics-expands-drug-pipeline-with-antibiotics-targeting-deadly-bacteria-217864.html
<![CDATA[Media files - Summit Therapeutics advancing its pipeline of innovative antibiotics ]]> https://www.proactiveinvestors.co.uk/companies/stocktube/12766/summit-therapeutics-advancing-its-pipeline-of-innovative-antibiotics-12766.html Thu, 28 Mar 2019 12:14:00 +0000 https://www.proactiveinvestors.co.uk/companies/stocktube/12766/summit-therapeutics-advancing-its-pipeline-of-innovative-antibiotics-12766.html <![CDATA[News - Summit Therapeutics well backed for next phase of development ]]> https://www.proactiveinvestors.co.uk/companies/news/217327/summit-therapeutics-well-backed-for-next-phase-of-development-217327.html Summit Therapeutics PLC’s (NASDAQ:SMMT) (LON:SUMM) prelims revealed the company is well-funded and well-backed after taking its next-generation antibiotic into the final and decisive stage of clinical trials.

The Phase III study of ridinilazole began last month (February). It will be tested against the standard of care drug vancomycin in patients with c.difficile, with the intent of showing it should be used as front-line treatment against the infection.

WATCH: Summit Therapeutics advancing its pipeline of innovative antibiotics

Successful Phase II trials revealed ridinilazole preserved the gut flora known as the microbiome in the way vancomycin doesn’t.

Financial results for the 12 months to the end of January showed Summit was sitting on almost £27mln of cash at the period-end.

BARDA backing 

The development of ridinilazole is being supported by a contract with the US Biomedical Advanced Research and Development Authority (BARDA) potentially worth £47mln (US$62mln).

Of that, £33mln ($44mln) has been committed, including a £9.1mln ($12mln) option that was exercised last August.

Summit has also been awarded up to £3.4mln ($4.5mln) by CARB-X, a public-private partnership, that will be used to develop its pre-clinical candidate for gonorrhoea.

The company made a profit for 2018 of £5mln (compared with a £24mln loss in 2017) as it recognised all the deferred revenues from an agreement it had with NASDAQ-listed Sarepta Therapeutics.

This followed the decision to stop work on the company’s other drug candidate, ezutromid, which had been developed for Duchenne Muscular Dystrophy.

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Wed, 27 Mar 2019 11:54:00 +0000 https://www.proactiveinvestors.co.uk/companies/news/217327/summit-therapeutics-well-backed-for-next-phase-of-development-217327.html
<![CDATA[News - Summit Therapeutics shows off potential of Discuva platform at Berlin conference ]]> https://www.proactiveinvestors.co.uk/companies/news/216479/summit-therapeutics-shows-off-potential-of-discuva-platform-at-berlin-conference-216479.html Summit Therapeutics PLC (LON:SUMM) has unveiled two new presentations at an industry conference in Berlin.

The presentations show off the potential of Summit’s Discuva platform, which it is using to identify and develop new antibiotics that infections such as gonorrhoea and staph aren’t resistant to.

READ: Summit’s gonorrhoea antibiotic showing promise

Several programmes of new mechanism antibiotics have emerged from the Discuva Platform, including one targeting gonorrhoea and another targeting ESKAPE pathogens.

Both of those programmes are being discussed at the conference.

“Antimicrobial resistance is a worldwide problem. We need to see scientific innovation to prevent an era of untreatable infections,” said Summit’s president of R&D, David Roblin.

“Through the Discuva Platform, we are using novel science to create targeted, new mechanism antibiotics that are optimised against resistance development.

“Our goal is to develop the most appropriate drug for a specific patient, thereby improving patient outcomes and giving physicians options to address the spread of AMR.”

Summit shares were up 1.6% to 30.5p in early afternoon trading on Thursday.

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Thu, 14 Mar 2019 12:15:00 +0000 https://www.proactiveinvestors.co.uk/companies/news/216479/summit-therapeutics-shows-off-potential-of-discuva-platform-at-berlin-conference-216479.html
<![CDATA[News - Summit Therapeutics shoots higher as data shows SMT-57 antibiotic potent against diverse, global gonorrhoeae strains ]]> https://www.proactiveinvestors.co.uk/companies/news/215227/summit-therapeutics-shoots-higher-as-data-shows-smt-57-antibiotic-potent-against-diverse-global-gonorrhoeae-strains-215227.html Summit Therapeutics PLC (LON:SUMM) (NASDAQ:SMMT) shares shot higher on Monday after the group said published preclinical data showed the SMT-571 new mechanism antibiotic it is developing was found to be potent against diverse, global gonorrhoeae strains.

The AIM and Nasdaq-listed firm added that SMT-571 – which is being developed in collaboration with the Örebro University in Sweden – was potent against Neisseria gonorrhoeae strains from actual patient cases, including numerous multi- and extensively-drug resistant strains.

READ: Summit Therapeutics says first patient dosed in global Phase 3 clinical trials for its precision oral antibiotic, ridinilazole

Professor Magnus Unemo, of Örebro University, a WHO Collaborating Centre for Gonorrhoea and Other Sexually Transmitted Infections, and senior author of the paper, commented: “Antibiotics with a new mechanism of action will be important in addressing the global health threat of gonorrhoea.

“In the published data, we demonstrated that SMT-571, a new mechanism antibiotic, had consistently high potency across hundreds of relevant clinical strains of N. gonorrhoeae, including those that are multi- and extensively-drug resistant. I look forward to the continued development of SMT-571.”

The paper, entitled ‘In vitro activity of the novel oral antimicrobial SMT-571, with a new mechanism of action, against MDR and XDR Neisseria gonorrhoeae: future treatment option for gonorrhoea?,’ was published in the Journal of Antimicrobial Chemotherapy and authored by Unemo and S. Jacobsson of Örebro University, as well as C. Mason, N. Khan and P. Meo of Summit.

In the study, Summit, said, researchers tested SMT-571 against 228 clinical isolates and 34 international gonococcal reference strains. SMT-571 achieved potent activity with minimum inhibitory concentrations of 0.064 to 0.125 mg/L against all tested strains.

Importantly, it added, SMT-571 did not show cross-resistance with any antimicrobials currently or previously used for the treatment of gonorrhoea.

These data further expand the range of N. gonorrhoeae strains against which SMT-571 has shown activity, indicating SMT-571 is a promising new mechanism antibiotic in development for the treatment of gonorrhoea, Summit concluded.

In early afternoon trading in London, Summit shares were 14% higher at 24.50p, having initially jumped to 28p a share.

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Mon, 25 Feb 2019 12:49:00 +0000 https://www.proactiveinvestors.co.uk/companies/news/215227/summit-therapeutics-shoots-higher-as-data-shows-smt-57-antibiotic-potent-against-diverse-global-gonorrhoeae-strains-215227.html
<![CDATA[News - Bryan Garnier sets 155p fair value target on Summit Therapeutics, offering around 550% upside ]]> https://www.proactiveinvestors.co.uk/companies/news/214894/bryan-garnier-sets-155p-fair-value-target-on-summit-therapeutics-offering-around-550-upside-214894.html Bryan Garnier & Co. has initiated coverage on Summit Therapeutics PLC (LON:SUMM) (NASDAQ:SMMT) with a fair value target of 155p, offering around 550% upside to the innovative biotech firm’s current share price of 22.50p.

The French broker was appointed Summit’s joint corporate broker, joining N+1 Singer back in November 2018, pointed out that the Oxford-based company is focused on developing novel, best-in-class antibiotics with new mechanisms of action specific for bacteria such as C.difficile, N.gonorrhoea, and others.

WATCH: Summit Therapeutics to begin Phase 3 studies of ridinilazole this quarter

In a note to clients, Bryan Garnier’s analysts said: “In this era of growing threats to health and medical practice coming from ever more resistant super strains of antibioticresistant bacterial, it is timely that Summit Therapeutics is driving new mechanism antibiotics into clinical development.”

They added Summit’s novel antibiotics targeting specific pathogens are being developed in clinical trials designed to deliver ‘superiority’ data to support their use as first-line treatments.

The analysts pointed out that Summit’s proprietary antibiotic discovery platform, Discuva, identifies new targets critical for bacterial survival and appropriate drugs against them.

Two antibiotic candidates in the pipeline

They noted that Summit currently has two new mechanism antibiotic candidates in the pipeline, ridinilazole and SMT-571.

Ridinilazole, now in Phase 3 development with the first patient dosed - announced 13 February - is a targeted treatment for C.difficile aiming to replicate Phase 2 results showing superiority over standard of care, vancomycin, in the cure and reduced recurrence of C.difficile infection.

SMT-571, a novel candidate to treat N.gonorrhoea infections, is expected to enter Phase 1 in H2 2019.

Alongside this, Summit plans to undertake new preclinical testing on new compounds for the treatment of the highly resistant ESKAPE pathogens over the next year. Summit is currently focusing its discovery and development efforts on WHO priority pathogen-targeted antibiotics with novel mechanisms of action. 

The analysts said: “With an estimated £26mln of cash plus non-dilutive funding (BARDA and CARB-X) and having just commenced a phase 3 programme of ridinilazole, we have established a fair value for Summit which we believe more accurately reflects its fundamental value than the current share price of 24p.”

They concluded: “On the basis of our risk-adjusted SOTP model, we value Summit at 155p per share (£249mln) making now an excellent entry point.”

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Tue, 19 Feb 2019 14:33:00 +0000 https://www.proactiveinvestors.co.uk/companies/news/214894/bryan-garnier-sets-155p-fair-value-target-on-summit-therapeutics-offering-around-550-upside-214894.html
<![CDATA[News - Summit Therapeutics says first patient dosed in global Phase 3 clinical trials for its precision oral antibiotic, ridinilazole ]]> https://www.proactiveinvestors.co.uk/companies/news/214546/summit-therapeutics-says-first-patient-dosed-in-global-phase-3-clinical-trials-for-its-precision-oral-antibiotic-ridinilazole-214546.html Summit Therapeutics PLC (LON:SUMM) (NASDAQ:SMMT) said it has dosed the first patient in the global Phase 3 clinical trials of its precision oral antibiotic, ridinilazole, for C. difficile infection (CDI).

The AIM-listed group, a leader in new mechanism antibiotic innovation, said the Phase 3 trials aim to show superiority of ridinilazole over the standard of care, vancomycin, in a measure that combines CDI cure and recurrence called sustained clinical response (SCR). It pointed out that ridinilazole achieved statistical superiority over vancomycin in SCR in a Phase 2 clinical trial.

WATCH: Summit Therapeutics to begin Phase 3 studies of ridinilazol this quarter

Glyn Edwards, chief executive officer of Summit commented: “Starting our Phase 3 programme is an important milestone for Summit. With positive results, we believe ridinilazole could be positioned as the drug of choice in the front-line treatment of CDI, which potentially provides patients with sustained cures and hospitals with compelling cost savings.”

The group said the Phase 3 clinical programme comprises two global, randomised, double-blind, active-controlled clinical trials which will be run concurrently with each expected to enrol approximately 680 patients at sites in North America, Latin America, Europe, Australia and Asia.

It added that top-line data from the Phase 3 programme are expected to be reported in the second half of 2021.

The clinical and regulatory development of ridinilazole is being funded in part with Federal funds from the US Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA).

Summit is eligible to receive up to $62mln in funding from BARDA to support the clinical and regulatory development of ridinilazole.

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Wed, 13 Feb 2019 12:14:00 +0000 https://www.proactiveinvestors.co.uk/companies/news/214546/summit-therapeutics-says-first-patient-dosed-in-global-phase-3-clinical-trials-for-its-precision-oral-antibiotic-ridinilazole-214546.html
<![CDATA[Media files - Summit Therapeutics to begin Phase 3 studies of ridinilazol this quarter ]]> https://www.proactiveinvestors.co.uk/companies/stocktube/12162/summit-therapeutics-to-begin-phase-3-studies-of-ridinilazol-this-quarter-12162.html Mon, 11 Feb 2019 10:12:00 +0000 https://www.proactiveinvestors.co.uk/companies/stocktube/12162/summit-therapeutics-to-begin-phase-3-studies-of-ridinilazol-this-quarter-12162.html <![CDATA[Media files - Summit Therapeutics welcomes investment from US billionaire ahead of busy Q1 ]]> https://www.proactiveinvestors.co.uk/companies/stocktube/11836/summit-therapeutics-welcomes-investment-from-us-billionaire-ahead-of-busy-q1-11836.html Mon, 14 Jan 2019 15:57:00 +0000 https://www.proactiveinvestors.co.uk/companies/stocktube/11836/summit-therapeutics-welcomes-investment-from-us-billionaire-ahead-of-busy-q1-11836.html <![CDATA[News - Bob Duggan: Meet the US biotech billionaire taking a 49% stake in Summit ]]> https://www.proactiveinvestors.co.uk/companies/news/211351/bob-duggan-meet-the-us-biotech-billionaire-taking-a-49-stake-in-summit-211351.html Summit Therapeutics PLC (LON:SUMM) shares surged on Monday after it was confirmed that US biotech billionaire Bob Duggan is to take a large stake in the antibiotics specialist.

Duggan has agreed to plough US$25mln into Summit, which will leave him with just shy of 49% of the shares once all the papers have been completed.

WATCH:Summit Therapeutics welcomes investment from US billionaire ahead of busy Q1 IN-DEPTH: What has Duggan got himself in Summit?

Many investors have been speculating why he has decided to invest such a handsome sum – and at a premium – but it appears the answer might be very simple: he likes what he sees.

According to people close to the transaction, the 74-year-old has been looking to invest in antibiotics having recognised the need for more drug development in the space.

He is understood to like Summit’s intellectual property (IP), including its ridinilazole C. Diff treatment, as well as the strategy of the management, whom he is said to know and respect.

Likes the tech and the strategy

That partly explains why he isn’t keen on making a formal offer for the company, preferring instead to let bosses get on with what they’re doing.

They will no doubt seek out his advice should they need to, though, especially given his track record and reputation within the biotech sector.

His turnaround of Pharmacylicals, the company which developed blockbuster cancer drug Imbruvica, culminated in its sale to US pharma giant AbbVie Inc (NYSE:ABBT) for US$21bn back in 2015, making him a billionaire in the process.

Before that, Duggan had already had success building and selling companies, although his investments – Computer Motion and Computer Machinery Corp, for example – tended to have more of a focus.

Son’s death sparked pharma interest

It was only after the death of his son from brain cancer back in 2004 that his interest in developing new, potentially life-changing drugs really piqued.

The keen surfer began buying up shares in Pharmacyclics for under US$10, with the stock having suffered various regulatory setbacks and close to collapse.

When he took the helm in 2008, he prioritised the development of Imbruvica, the success of which propped up the stock price and prompted AbbVie to cough up US$261.25 a share seven years later.

Duggan, a keen surfer who now lives in Florida, has used the huge payday from Pharmacyclicals to invest in other pharma firms.

He is the chairman and largest shareholder of Pulse Biosciences Inc (NASDAQ:PLSE) – a US$200mln company which is trying to harness the power of electricity to shock the immune system into producing a positive response.

Mates with Tom Cruise (possibly)

His money has also gone into one of his other passions: the Church of Scientology.

Duggan is often cited as the wealthiest member of the Church of Scientology and is rumoured to be the church’s biggest financial backer.

According to reports, he has donated tens of millions in the name of religion over the past decade or so, claiming in one interview that it is an “honour and personal obligation” to share his financial success with Scientology.

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Mon, 17 Dec 2018 16:30:00 +0000 https://www.proactiveinvestors.co.uk/companies/news/211351/bob-duggan-meet-the-us-biotech-billionaire-taking-a-49-stake-in-summit-211351.html
<![CDATA[News - US billionaire Robert Duggan to invest US$25mln into Summit Therapeutics ]]> https://www.proactiveinvestors.co.uk/companies/news/211298/us-billionaire-robert-duggan-to-invest-us25mln-into-summit-therapeutics-211298.html A US healthcare entrepreneur is set to take a large stake in Summit Therapeutics PLC (LON:SUMM) after agreeing to pump US$25mln into the antibiotics specialist.

Robert Duggan was the chief executive and chairman of Pharmacyclics before it was sold to pharma giant AbbVie Inc (NYSE:ABBV) for US$21bn in 2015.

Through Pharmacyclics, the billionaire oversaw the development of ibrutinib (Imbruvica), a cancer drug which notched up sales of more than US$2.5bn last year.

READ: Summit well-funded as it gears up for ridinilazole phase III trial

He has agreed to pay US$1.60 for 15.63mln Summit American depositary shares – a 32% premium to the quoted Nasdaq price on Friday. The deal is equivalent to 78.13mln ordinary shares at roughly 25p each.

The purchase will take Duggan’s stake, which sat at just 0.2% before, to 48.8%.

Typically, any shareholder who owns more than 30% of a company’s shares is required to make a formal offer to the other investors.

Duggan doesn’t want to do that this time though, and his investment is conditional upon shareholders voting to approve a waiver allowing him to not make such an offer.

Assuming investors vote with the board and the investment goes ahead as planned, Summit will use the money to begin patient enrolment into the phase III clinical trial of its ridinilazole C Difficile treatment.

The fresh capital will also go towards completing investigational new drug (IND) application-enabling studies for SMT-571 – the company’s gonorrhoea candidate.

Duggan’s investment ‘speaks volumes’

On top of all that, it will also be used to accelerate the development of treatments for hospital-acquired superbugs, known as ESKAPE pathogens.

Summit estimates that the investment will extend its cash runway through to the end of January 2020.

“Mr Duggan is a seasoned healthcare entrepreneur and investor whose proposed investment into our company speaks volumes about the potential that our new mechanism antibiotics have in addressing serious infectious diseases,” said chief executive Glyn Edwards.

“We are thrilled with his commitment to Summit and look forward to advancing our programmes targeting infections caused by C. difficile, N. gonorrhoea and ESKAPE pathogens and showing significant advantages over current standards of care.”

In a separate statement, Summit confirmed chief financial officer Erik Ostrowski is to step down from his role at the end of the month to pursue another opportunity.

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Mon, 17 Dec 2018 07:44:00 +0000 https://www.proactiveinvestors.co.uk/companies/news/211298/us-billionaire-robert-duggan-to-invest-us25mln-into-summit-therapeutics-211298.html
<![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.

WATCH: Summit Therapeutics to begin Phase 3 studies of ridinilazol this quarter

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.

READ: Summit presents data on new gonorrhoea treatment

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 - Summit funded through to 2020 thanks to US$25mln investment from US biotech billionaire ]]> https://www.proactiveinvestors.co.uk/companies/news/205338/summit-funded-through-to-2020-thanks-to-us25mln-investment-from-us-biotech-billionaire-205338.html Summit Therapeutics PLC (LON:SUMM NASDAQ:SMMT) now has enough cash in the bank to comfortably last through to the end of January 2020.

The biotech’s coffers have been given a US$25mln boost from US billionaire Bob Duggan, who has agreed to take a 48.8% stake in the company.

He’s paying a premium for his shares, too, some 32% above the asking price on Nasdaq on Friday afternoon.

READ: US billionaire invests in Summit

Duggan was the chief executive and chairman of Pharmacyclics, the company behind blockbuster cancer drug Imbruvica which was sold to AbbVie Inc (NYSE:ABBV) for US$21bn back in 2015.

The fresh capital means Summit has more than enough in the bank to begin patient enrolment into the phase III clinical trial of its ridinilazole C. Difficile treatment in the first quarter of 2019.

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.

Ezutromid disappointment

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.

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, 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.

Next year looks set to be a busy one for Summit, but with Duggan’s backing, financing it all is one less thing for management to have to worry about.

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Thu, 20 Sep 2018 13:00:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/205338/summit-funded-through-to-2020-thanks-to-us25mln-investment-from-us-biotech-billionaire-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