Proactiveinvestors USA & Canada Summit Therapeutics PLC https://www.proactiveinvestors.com Proactiveinvestors USA & Canada Summit Therapeutics PLC RSS feed en Wed, 17 Jul 2019 01:37:57 -0400 http://blogs.law.harvard.edu/tech/rss Genera CMS action@proactiveinvestors.com (Proactiveinvestors) action@proactiveinvestors.com (Proactiveinvestors) <![CDATA[RNS press release - Summit’s DDS-04 Enterobacteriaceae Programme Demonstrates In Vivo Efficacy in Sepsis and Pneumonia ]]> https://www.proactiveinvestors.com/companies/rns/962/NASDAQ_1000251455-en/ Tue, 09 Jul 2019 07:00:00 -0400 https://www.proactiveinvestors.com/companies/rns/962/NASDAQ_1000251455-en/ <![CDATA[RNS press release - Summit to Present on Pipeline and Strategy for its New Classes of Antibiotics at ASM Microbe 2019 ]]> https://www.proactiveinvestors.com/companies/rns/962/NASDAQ_1000198417-en/ Thu, 20 Jun 2019 07:00:00 -0400 https://www.proactiveinvestors.com/companies/rns/962/NASDAQ_1000198417-en/ <![CDATA[RNS press release - Result of AGM ]]> https://www.proactiveinvestors.com/companies/rns/962/NASDAQ_1000198313-en/ Wed, 19 Jun 2019 07:00:00 -0400 https://www.proactiveinvestors.com/companies/rns/962/NASDAQ_1000198313-en/ <![CDATA[RNS press release - Increased BARDA Award and Option Exercise ]]> https://www.proactiveinvestors.com/companies/rns/962/NASDAQ_1000198146-en/ Tue, 18 Jun 2019 07:00:00 -0400 https://www.proactiveinvestors.com/companies/rns/962/NASDAQ_1000198146-en/ <![CDATA[RNS press release - Summit Therapeutics Reports Financial Results and Operational Progress for the First Quarter Ended 30 April 2019 ]]> https://www.proactiveinvestors.com/companies/rns/962/NASDAQ_1000197265-en/ Wed, 12 Jun 2019 07:00:00 -0400 https://www.proactiveinvestors.com/companies/rns/962/NASDAQ_1000197265-en/ <![CDATA[RNS press release - Notice of First Quarter Results ]]> https://www.proactiveinvestors.com/companies/rns/962/NASDAQ_1000196271-en/ Wed, 05 Jun 2019 09:00:00 -0400 https://www.proactiveinvestors.com/companies/rns/962/NASDAQ_1000196271-en/ <![CDATA[RNS press release - UK Annual Report and Notice of AGM ]]> https://www.proactiveinvestors.com/companies/rns/962/NASDAQ_1000192706-en/ Tue, 14 May 2019 12:30:00 -0400 https://www.proactiveinvestors.com/companies/rns/962/NASDAQ_1000192706-en/ <![CDATA[RNS press release - Block Listing Interim Review ]]> https://www.proactiveinvestors.com/companies/rns/962/NASDAQ_1000190026-en/ Mon, 29 Apr 2019 07:30:00 -0400 https://www.proactiveinvestors.com/companies/rns/962/NASDAQ_1000190026-en/ <![CDATA[RNS press release - Exercise of Restricted Stock Units ]]> https://www.proactiveinvestors.com/companies/rns/962/NASDAQ_1000179186-en/ Wed, 24 Apr 2019 11:20:00 -0400 https://www.proactiveinvestors.com/companies/rns/962/NASDAQ_1000179186-en/ <![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.com/companies/rns/962/NASDAQ_1000177816-en/ Mon, 15 Apr 2019 02:00:00 -0400 https://www.proactiveinvestors.com/companies/rns/962/NASDAQ_1000177816-en/ <![CDATA[RNS press release - Summit’s Pipeline Expands with Series of New Mechanism Antibiotics Targeting Enterobacteriaceae ]]> https://www.proactiveinvestors.com/companies/rns/962/NASDAQ_1000176021-en/ Wed, 03 Apr 2019 07:00:00 -0400 https://www.proactiveinvestors.com/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.com/companies/rns/962/NASDAQ_1000175675-en/ Tue, 02 Apr 2019 07:00:00 -0400 https://www.proactiveinvestors.com/companies/rns/962/NASDAQ_1000175675-en/ <![CDATA[RNS press release - Award of Share Options ]]> https://www.proactiveinvestors.com/companies/rns/962/NASDAQ_1000155268-en/ Fri, 29 Mar 2019 13:45:00 -0400 https://www.proactiveinvestors.com/companies/rns/962/NASDAQ_1000155268-en/ <![CDATA[RNS press release - Filing of Annual Report on Form 20-F ]]> https://www.proactiveinvestors.com/companies/rns/962/NASDAQ_1000155118-en/ Fri, 29 Mar 2019 07:15:00 -0400 https://www.proactiveinvestors.com/companies/rns/962/NASDAQ_1000155118-en/ <![CDATA[RNS press release - Final Results ]]> https://www.proactiveinvestors.com/companies/rns/962/NASDAQ_1000154580-en/ Wed, 27 Mar 2019 07:00:00 -0400 https://www.proactiveinvestors.com/companies/rns/962/NASDAQ_1000154580-en/ <![CDATA[RNS press release - Notice of Results ]]> https://www.proactiveinvestors.com/companies/rns/962/NASDAQ_1000154137-en/ Mon, 25 Mar 2019 07:00:00 -0400 https://www.proactiveinvestors.com/companies/rns/962/NASDAQ_1000154137-en/ <![CDATA[RNS press release - Summit Therapeutics to Present at Upcoming Conferences ]]> https://www.proactiveinvestors.com/companies/rns/962/NASDAQ_1000152799-en/ Mon, 18 Mar 2019 07:00:00 -0400 https://www.proactiveinvestors.com/companies/rns/962/NASDAQ_1000152799-en/ <![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.com/companies/rns/962/NASDAQ_1000152451-en/ Thu, 14 Mar 2019 07:00:00 -0400 https://www.proactiveinvestors.com/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.com/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 -0500 https://www.proactiveinvestors.com/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.com/companies/rns/962/NASDAQ_1000149429-en/ Mon, 25 Feb 2019 07:00:00 -0500 https://www.proactiveinvestors.com/companies/rns/962/NASDAQ_1000149429-en/ <![CDATA[RNS press release - Summit Doses First Patient in Phase 3 Clinical Trials of Precision Antibiotic Ridinilazole for C. Difficile Infection ]]> https://www.proactiveinvestors.com/companies/rns/962/NASDAQ_1000147881-en/ Wed, 13 Feb 2019 07:00:00 -0500 https://www.proactiveinvestors.com/companies/rns/962/NASDAQ_1000147881-en/ <![CDATA[Media files - Summit Therapeutics to begin Phase 3 studies of ridinilazol this quarter ]]> https://www.proactiveinvestors.com/companies/stocktube/12162/summit-therapeutics-to-begin-phase-3-studies-of-ridinilazol-this-quarter-12162.html Mon, 11 Feb 2019 10:12:00 -0500 https://www.proactiveinvestors.com/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.com/companies/rns/962/NASDAQ_1000147215-en/ Fri, 08 Feb 2019 07:00:00 -0500 https://www.proactiveinvestors.com/companies/rns/962/NASDAQ_1000147215-en/ <![CDATA[RNS press release - Holding(s) in Company ]]> https://www.proactiveinvestors.com/companies/rns/962/NASDAQ_1000144181-en/ Tue, 15 Jan 2019 12:45:00 -0500 https://www.proactiveinvestors.com/companies/rns/962/NASDAQ_1000144181-en/ <![CDATA[RNS press release - Award of Restricted Stock Units ]]> https://www.proactiveinvestors.com/companies/rns/962/NASDAQ_1000143969-en/ Mon, 14 Jan 2019 07:00:00 -0500 https://www.proactiveinvestors.com/companies/rns/962/NASDAQ_1000143969-en/ <![CDATA[RNS press release - Holding(s) in Company ]]> https://www.proactiveinvestors.com/companies/rns/962/NASDAQ_1000143638-en/ Thu, 10 Jan 2019 11:15:00 -0500 https://www.proactiveinvestors.com/companies/rns/962/NASDAQ_1000143638-en/ <![CDATA[RNS press release - Holding(s) in Company ]]> https://www.proactiveinvestors.com/companies/rns/962/NASDAQ_1000143601-en/ Thu, 10 Jan 2019 06:30:00 -0500 https://www.proactiveinvestors.com/companies/rns/962/NASDAQ_1000143601-en/ <![CDATA[RNS press release - Completion of $25 million Subscription ]]> https://www.proactiveinvestors.com/companies/rns/962/NASDAQ_1000143508-en/ Thu, 10 Jan 2019 02:00:00 -0500 https://www.proactiveinvestors.com/companies/rns/962/NASDAQ_1000143508-en/ <![CDATA[RNS press release - Holding(s) in Company ]]> https://www.proactiveinvestors.com/companies/rns/962/NASDAQ_1000143487-en/ Wed, 09 Jan 2019 11:45:00 -0500 https://www.proactiveinvestors.com/companies/rns/962/NASDAQ_1000143487-en/ <![CDATA[RNS press release - Update on Admission ]]> https://www.proactiveinvestors.com/companies/rns/962/NASDAQ_1000143234-en/ Tue, 08 Jan 2019 02:00:00 -0500 https://www.proactiveinvestors.com/companies/rns/962/NASDAQ_1000143234-en/ <![CDATA[RNS press release - Result of General Meeting ]]> https://www.proactiveinvestors.com/companies/rns/962/NASDAQ_1000142886-en/ Fri, 04 Jan 2019 07:30:00 -0500 https://www.proactiveinvestors.com/companies/rns/962/NASDAQ_1000142886-en/ <![CDATA[RNS press release - Holding(s) in Company ]]> https://www.proactiveinvestors.com/companies/rns/962/NASDAQ_1000142586-en/ Wed, 02 Jan 2019 04:40:00 -0500 https://www.proactiveinvestors.com/companies/rns/962/NASDAQ_1000142586-en/ <![CDATA[RNS press release - Holding(s) in Company ]]> https://www.proactiveinvestors.com/companies/rns/962/NASDAQ_1000140906-en/ Tue, 18 Dec 2018 07:15:00 -0500 https://www.proactiveinvestors.com/companies/rns/962/NASDAQ_1000140906-en/ <![CDATA[News - Bob Duggan: Meet the US biotech billionaire taking a 49% stake in Summit ]]> https://www.proactiveinvestors.com/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 -0500 https://www.proactiveinvestors.com/companies/news/211351/bob-duggan-meet-the-us-biotech-billionaire-taking-a-49-stake-in-summit-211351.html
<![CDATA[RNS press release - Proposed Subscription to Raise $25m and Notice of General Meeting ]]> https://www.proactiveinvestors.com/companies/rns/962/NASDAQ_1000140674-en/ Mon, 17 Dec 2018 02:05:00 -0500 https://www.proactiveinvestors.com/companies/rns/962/NASDAQ_1000140674-en/ <![CDATA[RNS press release - Summit Therapeutics Announces Departure of Chief Financial Officer ]]> https://www.proactiveinvestors.com/companies/rns/962/NASDAQ_1000140646-en/ Mon, 17 Dec 2018 02:00:00 -0500 https://www.proactiveinvestors.com/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.com/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 -0500 https://www.proactiveinvestors.com/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.com/companies/rns/962/NASDAQ_1000139925-en/ Tue, 11 Dec 2018 07:00:00 -0500 https://www.proactiveinvestors.com/companies/rns/962/NASDAQ_1000139925-en/ <![CDATA[News - Summit Therapeutics awarded additional US$12mln under contract with US BARDA ]]> https://www.proactiveinvestors.com/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 -0400 https://www.proactiveinvestors.com/companies/news/203060/summit-therapeutics-awarded-additional-us12mln-under-contract-with-us-barda-203060.html
<![CDATA[News - Summit Therapeutics says PhaseOut DMD clinical trial did not meet primary endpoint ]]> https://www.proactiveinvestors.com/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 -0400 https://www.proactiveinvestors.com/companies/news/199681/summit-therapeutics-says-phaseout-dmd-clinical-trial-did-not-meet-primary-endpoint-199681.html
<![CDATA[News - Summit Therapeutics boosted by new DMD drug analysis ]]> https://www.proactiveinvestors.com/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 -0400 https://www.proactiveinvestors.com/companies/news/195472/summit-therapeutics-boosted-by-new-dmd-drug-analysis-195472.html
<![CDATA[News - Summit Therapeutics completes dosing of ezutromid in PhaseOut DMD clinical trial ]]> https://www.proactiveinvestors.com/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 -0400 https://www.proactiveinvestors.com/companies/news/195368/summit-therapeutics-completes-dosing-of-ezutromid-in-phaseout-dmd-clinical-trial-195368.html
<![CDATA[News - Summit Therapeutics raises around £15mln from placing to advance its treatment for Duchenne Muscular Dystrophy ]]> https://www.proactiveinvestors.com/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 -0400 https://www.proactiveinvestors.com/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.com/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 -0400 https://www.proactiveinvestors.com/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.com/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 -0400 https://www.proactiveinvestors.com/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.com/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 -0500 https://www.proactiveinvestors.com/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.com/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 -0500 https://www.proactiveinvestors.com/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[News - Summit Therapeutics shares jump on 'exciting' interim results of ezutromid study ]]> https://www.proactiveinvestors.com/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 -0500 https://www.proactiveinvestors.com/companies/news/190634/summit-therapeutics-shares-jump-on-exciting-interim-results-of-ezutromid-study-190634.html
<![CDATA[RNS press release - Acquisition of Discuva Ltd ]]> https://www.proactiveinvestors.com/companies/rns/962/LSE20171227070006_13476877/ Wed, 27 Dec 2017 02:00:06 -0500 https://www.proactiveinvestors.com/companies/rns/962/LSE20171227070006_13476877/ <![CDATA[News - Summit Thereapeutics surges as it licenses the Latin American rights to its CDI candidate ]]> https://www.proactiveinvestors.com/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 -0500 https://www.proactiveinvestors.com/companies/news/189154/summit-thereapeutics-surges-as-it-licenses-the-latin-american-rights-to-its-cdi-candidate-189154.html