Proactiveinvestors United Kingdom Summit Therapeutics PLC https://www.proactiveinvestors.co.uk Proactiveinvestors United Kingdom Summit Therapeutics PLC RSS feed en Wed, 19 Jun 2019 07:55:01 +0100 http://blogs.law.harvard.edu/tech/rss Genera CMS action@proactiveinvestors.com (Proactiveinvestors) action@proactiveinvestors.com (Proactiveinvestors) <![CDATA[News - Summit Therapeutics in line to receive funding of up to US$64mln from US government ]]> https://www.proactiveinvestors.co.uk/companies/news/222332/summit-therapeutics-in-line-to-receive-funding-of-up-to-us64mln-from-us-government-222332.html Summit Therapeutics PLC (LON:SUMM) is in line to receive almost US$64mln from the US government to help fund the development of its ridinilazole antibiotic as a treatment for C. difficile (CDI).

The Biomedic Advanced Research and Development Authority (BARDA), part of the US Department of Health and Human Sciences, had already agreed to shell out US$44mln to cover the costs of taking ridinilazole through clinical trials.

READ: Summit well-placed in race to find new antibiotics

BARDA confirmed on Tuesday that it would provide another US$9.6mln in funding which will support patient enrolment and dosing in the ongoing phase 3 studies.

That takes the total amount committed by BARDA to US$53.6mln, although it might not be done there.

Summit had previously expected BARDA to provide up to US$62mln in funding, but officials said today that figure had been increased to US$63.7mln.

The plan is for the remaining US$10.1mln, or however much is committed, to be used to secure marketing approvals for ridnilazole further down the line.

“The funding from BARDA is a testament to the promise of ridinilazole to address an important public health need in CDI,” said Summit chief executive Glyn Edwards.

“Through our ongoing landmark Phase 3 clinical programme, we aim to show that our microbiome preserving antibiotic is superior in sustaining cures compared to the current standard of care and so has the potential to be the front-line treatment option for patients with CDI.”

He added: “We are pleased with the excellent working relationship that has been formed between us over the last two years and thank BARDA for its continuing support of ridinilazole.”

Why is the US government doing this?

While potential funding of almost US$64mln may seem a lot, the cost of not finding new treatments for CDI is even greater.

Summit estimates the cost of managing CDI is upwards of US$6bn every year in the US alone.

On top of that, the current antibiotics on the market aren’t always effective in getting rid of the disease for good, and CDI is often more dangerous – and more expensive to treat – when it does return.

Ridinilazole is currently going through phase 3 trials, but it has already shown promise in earlier studies.

In a phase 2 trial ridinilazole showed “statistical superiority” in treating the disease versus vancomycin, the current standard of care.

Summit shares were up 10% to 23.4p on Tuesday afternoon.

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Tue, 18 Jun 2019 13:00:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/222332/summit-therapeutics-in-line-to-receive-funding-of-up-to-us64mln-from-us-government-222332.html
<![CDATA[RNS press release - Increased BARDA Award and Option Exercise ]]> https://www.proactiveinvestors.co.uk/companies/rns/962/NASDAQ_1000198146-en/ Tue, 18 Jun 2019 12:00:00 +0100 https://www.proactiveinvestors.co.uk/companies/rns/962/NASDAQ_1000198146-en/ <![CDATA[Media files - Summit Therapeutics 'taking leadership role' in development of new antibiotics ]]> https://www.proactiveinvestors.co.uk/companies/stocktube/13726/summit-therapeutics--taking-leadership-role--in-development-of-new-antibiotics-13726.html Thu, 13 Jun 2019 13:49:00 +0100 https://www.proactiveinvestors.co.uk/companies/stocktube/13726/summit-therapeutics--taking-leadership-role--in-development-of-new-antibiotics-13726.html <![CDATA[News - Summit Therapeutics reduces first quarter losses ]]> https://www.proactiveinvestors.co.uk/companies/news/221977/summit-therapeutics-reduces-first-quarter-losses-221977.html Summit Therapeutics PLC (LON:SUMM) has reported a reduced loss for its first quarter and increased its cash reserves.

For the three months ended 30 April 2019, the AIM-listed firm reported an operating loss of £4.8mln, down from £6.6mln a year ago.

Revenues, meanwhile, fell to £249,000 from £3.87mln year-on-year, which the company said was related to its Sarepta licence and collaboration agreement following the group’s decision to discontinue development of its ezutromid treatment in June 2018.

READ: Summit Therapeutics soars as it hails potential of very early stage antibiotic

Summit also ended the quarter with a cash balance of £28.3mln compared to £26.9mln a year ago, adding that it had enough funds to support its operating expenses and capital expenditure until the end of January 2020.

The group’s chief executive, Glyn Edwards, said that the company was taking a leadership role in developing new classes of antibiotics which had the potential to combat the “rising threat” of antibiotic resistance.

"We believe these new class antibiotics have the potential to transform patient lives and that it is possible to show clear advantages over standard of care treatments and cost effectiveness during development. With this differentiated approach, we believe we will have the opportunity to be commercially successful”, he added.

The firm is currently developing three flagship treatments; Ridinilazole, designed to treat Clostridium difficile which can cause diarrhoea, SMT-571 for Gonorrhoea and DDS-04 which is aiming to treat Enterobacteriaceae, a family of bacteria that includes salmonella.

In April, the company said the pre-clinical DDS-04 had successfully tackled Enterobacteriaceae in animals with urinary tract infections.

In early afternoon trading on Wednesday, Summit shares were steady at 23p.

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Wed, 12 Jun 2019 13:13:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/221977/summit-therapeutics-reduces-first-quarter-losses-221977.html
<![CDATA[RNS press release - Summit Therapeutics Reports Financial Results and Operational Progress for the First Quarter Ended 30 April 2019 ]]> https://www.proactiveinvestors.co.uk/companies/rns/962/NASDAQ_1000197265-en/ Wed, 12 Jun 2019 12:00:00 +0100 https://www.proactiveinvestors.co.uk/companies/rns/962/NASDAQ_1000197265-en/ <![CDATA[RNS press release - Notice of First Quarter Results ]]> https://www.proactiveinvestors.co.uk/companies/rns/962/NASDAQ_1000196271-en/ Wed, 05 Jun 2019 14:00:00 +0100 https://www.proactiveinvestors.co.uk/companies/rns/962/NASDAQ_1000196271-en/ <![CDATA[RNS press release - UK Annual Report and Notice of AGM ]]> https://www.proactiveinvestors.co.uk/companies/rns/962/NASDAQ_1000192706-en/ Tue, 14 May 2019 17:30:00 +0100 https://www.proactiveinvestors.co.uk/companies/rns/962/NASDAQ_1000192706-en/ <![CDATA[RNS press release - Block Listing Interim Review ]]> https://www.proactiveinvestors.co.uk/companies/rns/962/NASDAQ_1000190026-en/ Mon, 29 Apr 2019 12:30:00 +0100 https://www.proactiveinvestors.co.uk/companies/rns/962/NASDAQ_1000190026-en/ <![CDATA[RNS press release - Exercise of Restricted Stock Units ]]> https://www.proactiveinvestors.co.uk/companies/rns/962/NASDAQ_1000179186-en/ Wed, 24 Apr 2019 16:20:00 +0100 https://www.proactiveinvestors.co.uk/companies/rns/962/NASDAQ_1000179186-en/ <![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[RNS press release - Summit Presents In Vivo Proof of Concept Data for New Mechanism Antibiotics Targeting Enterobacteriaceae in Oral Session at ECCMID 2019 ]]> https://www.proactiveinvestors.co.uk/companies/rns/962/NASDAQ_1000177816-en/ Mon, 15 Apr 2019 07:00:00 +0100 https://www.proactiveinvestors.co.uk/companies/rns/962/NASDAQ_1000177816-en/ <![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[RNS press release - Summit’s Pipeline Expands with Series of New Mechanism Antibiotics Targeting Enterobacteriaceae ]]> https://www.proactiveinvestors.co.uk/companies/rns/962/NASDAQ_1000176021-en/ Wed, 03 Apr 2019 12:00:00 +0100 https://www.proactiveinvestors.co.uk/companies/rns/962/NASDAQ_1000176021-en/ <![CDATA[RNS press release - Summit Therapeutics to Present at H. C. Wainwright & Co. Global Life Sciences Conference ]]> https://www.proactiveinvestors.co.uk/companies/rns/962/NASDAQ_1000175675-en/ Tue, 02 Apr 2019 12:00:00 +0100 https://www.proactiveinvestors.co.uk/companies/rns/962/NASDAQ_1000175675-en/ <![CDATA[RNS press release - Award of Share Options ]]> https://www.proactiveinvestors.co.uk/companies/rns/962/NASDAQ_1000155268-en/ Fri, 29 Mar 2019 17:45:00 +0000 https://www.proactiveinvestors.co.uk/companies/rns/962/NASDAQ_1000155268-en/ <![CDATA[RNS press release - Filing of Annual Report on Form 20-F ]]> https://www.proactiveinvestors.co.uk/companies/rns/962/NASDAQ_1000155118-en/ Fri, 29 Mar 2019 11:15:00 +0000 https://www.proactiveinvestors.co.uk/companies/rns/962/NASDAQ_1000155118-en/ <![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[RNS press release - Final Results ]]> https://www.proactiveinvestors.co.uk/companies/rns/962/NASDAQ_1000154580-en/ Wed, 27 Mar 2019 11:00:00 +0000 https://www.proactiveinvestors.co.uk/companies/rns/962/NASDAQ_1000154580-en/ <![CDATA[RNS press release - Notice of Results ]]> https://www.proactiveinvestors.co.uk/companies/rns/962/NASDAQ_1000154137-en/ Mon, 25 Mar 2019 11:00:00 +0000 https://www.proactiveinvestors.co.uk/companies/rns/962/NASDAQ_1000154137-en/ <![CDATA[RNS press release - Summit Therapeutics to Present at Upcoming Conferences ]]> https://www.proactiveinvestors.co.uk/companies/rns/962/NASDAQ_1000152799-en/ Mon, 18 Mar 2019 11:00:00 +0000 https://www.proactiveinvestors.co.uk/companies/rns/962/NASDAQ_1000152799-en/ <![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[RNS press release - Summit Highlights Use of Discuva Platform in Identifying New Mechanism Antibiotics against Neisseria Gonorrhoeae and ESKAPE Pathogens at Novel Antimicrobials and AMR Diagnostics 2019 Conference ]]> https://www.proactiveinvestors.co.uk/companies/rns/962/NASDAQ_1000152451-en/ Thu, 14 Mar 2019 11:00:00 +0000 https://www.proactiveinvestors.co.uk/companies/rns/962/NASDAQ_1000152451-en/ <![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[RNS press release - Summit’s SMT-571 Potent Against Over 200 Clinical Isolates of Neisseria Gonorrhoeae, Including Numerous Multi- and Extensively-Drug Resistant Strains, in Published Preclinical Data ]]> https://www.proactiveinvestors.co.uk/companies/rns/962/NASDAQ_1000149429-en/ Mon, 25 Feb 2019 12:00:00 +0000 https://www.proactiveinvestors.co.uk/companies/rns/962/NASDAQ_1000149429-en/ <![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[RNS press release - Summit Doses First Patient in Phase 3 Clinical Trials of Precision Antibiotic Ridinilazole for C. Difficile Infection ]]> https://www.proactiveinvestors.co.uk/companies/rns/962/NASDAQ_1000147881-en/ Wed, 13 Feb 2019 12:00:00 +0000 https://www.proactiveinvestors.co.uk/companies/rns/962/NASDAQ_1000147881-en/ <![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[RNS press release - Summit Therapeutics to Present at the BIO CEO & Investor Conference ]]> https://www.proactiveinvestors.co.uk/companies/rns/962/NASDAQ_1000147215-en/ Fri, 08 Feb 2019 12:00:00 +0000 https://www.proactiveinvestors.co.uk/companies/rns/962/NASDAQ_1000147215-en/ <![CDATA[RNS press release - Holding(s) in Company ]]> https://www.proactiveinvestors.co.uk/companies/rns/962/NASDAQ_1000144181-en/ Tue, 15 Jan 2019 17:45:00 +0000 https://www.proactiveinvestors.co.uk/companies/rns/962/NASDAQ_1000144181-en/ <![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[RNS press release - Award of Restricted Stock Units ]]> https://www.proactiveinvestors.co.uk/companies/rns/962/NASDAQ_1000143969-en/ Mon, 14 Jan 2019 12:00:00 +0000 https://www.proactiveinvestors.co.uk/companies/rns/962/NASDAQ_1000143969-en/ <![CDATA[RNS press release - Holding(s) in Company ]]> https://www.proactiveinvestors.co.uk/companies/rns/962/NASDAQ_1000143638-en/ Thu, 10 Jan 2019 16:15:00 +0000 https://www.proactiveinvestors.co.uk/companies/rns/962/NASDAQ_1000143638-en/ <![CDATA[RNS press release - Holding(s) in Company ]]> https://www.proactiveinvestors.co.uk/companies/rns/962/NASDAQ_1000143601-en/ Thu, 10 Jan 2019 11:30:00 +0000 https://www.proactiveinvestors.co.uk/companies/rns/962/NASDAQ_1000143601-en/ <![CDATA[RNS press release - Completion of $25 million Subscription ]]> https://www.proactiveinvestors.co.uk/companies/rns/962/NASDAQ_1000143508-en/ Thu, 10 Jan 2019 07:00:00 +0000 https://www.proactiveinvestors.co.uk/companies/rns/962/NASDAQ_1000143508-en/ <![CDATA[RNS press release - Holding(s) in Company ]]> https://www.proactiveinvestors.co.uk/companies/rns/962/NASDAQ_1000143487-en/ Wed, 09 Jan 2019 16:45:00 +0000 https://www.proactiveinvestors.co.uk/companies/rns/962/NASDAQ_1000143487-en/ <![CDATA[RNS press release - Update on Admission ]]> https://www.proactiveinvestors.co.uk/companies/rns/962/NASDAQ_1000143234-en/ Tue, 08 Jan 2019 07:00:00 +0000 https://www.proactiveinvestors.co.uk/companies/rns/962/NASDAQ_1000143234-en/ <![CDATA[RNS press release - Result of General Meeting ]]> https://www.proactiveinvestors.co.uk/companies/rns/962/NASDAQ_1000142886-en/ Fri, 04 Jan 2019 12:30:00 +0000 https://www.proactiveinvestors.co.uk/companies/rns/962/NASDAQ_1000142886-en/ <![CDATA[RNS press release - Holding(s) in Company ]]> https://www.proactiveinvestors.co.uk/companies/rns/962/NASDAQ_1000142586-en/ Wed, 02 Jan 2019 09:40:00 +0000 https://www.proactiveinvestors.co.uk/companies/rns/962/NASDAQ_1000142586-en/ <![CDATA[RNS press release - Holding(s) in Company ]]> https://www.proactiveinvestors.co.uk/companies/rns/962/NASDAQ_1000140906-en/ Tue, 18 Dec 2018 12:15:00 +0000 https://www.proactiveinvestors.co.uk/companies/rns/962/NASDAQ_1000140906-en/ <![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[RNS press release - Proposed Subscription to Raise $25m and Notice of General Meeting ]]> https://www.proactiveinvestors.co.uk/companies/rns/962/NASDAQ_1000140674-en/ Mon, 17 Dec 2018 07:05:00 +0000 https://www.proactiveinvestors.co.uk/companies/rns/962/NASDAQ_1000140674-en/ <![CDATA[RNS press release - Summit Therapeutics Announces Departure of Chief Financial Officer ]]> https://www.proactiveinvestors.co.uk/companies/rns/962/NASDAQ_1000140646-en/ Mon, 17 Dec 2018 07:00:00 +0000 https://www.proactiveinvestors.co.uk/companies/rns/962/NASDAQ_1000140646-en/ <![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[RNS press release - 3rd Quarter Results ]]> https://www.proactiveinvestors.co.uk/companies/rns/962/NASDAQ_1000139925-en/ Tue, 11 Dec 2018 12:00:00 +0000 https://www.proactiveinvestors.co.uk/companies/rns/962/NASDAQ_1000139925-en/ <![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