Summit Corporation PLC : Research Update

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April 17, 2013 05:00 ET

Summit Therapeutics plc

Summit Therapeutics plc

Summit Corporation plc

('Summit' or 'the Company')

NEW POSITIVE DATA ON C. DIFFICILE ANTIBIOTIC PROGRAMME TO BE PRESENTED AT INTERNATIONAL INFECTIOUS DISEASES CONFERENCE

Oxford, UK, 17 April 2013 - Summit (AIM: SUMM), a drug discovery and development company advancing therapies for Duchenne Muscular Dystrophy and C. difficile infections ('CDI'), announces that abstracts have now been released by the organising committee of the 23rd European Congress of Clinical Microbiology and Infectious Diseases ('ECCMID') which will be held in Berlin, Germany from 27 to 30 April 2013.  Summit will present new positive preclinical data on the novel, selective antibiotic SMT 19969 for the treatment of CDI.

Three presentations are being given by Summit and key collaborators with data being reported from preclinical efficacy and safety studies.  SMT 19969 is currently being evaluated in a Phase 1 clinical trial in healthy volunteers with top-line results expected to be reported during Q2 2013.  The programme is supported by a prestigious translational research award from the Wellcome Trust.

"We are pleased to be presenting positive preclinical data that further demonstrates the tremendous potential of SMT 19969 for the treatment of C. difficile infections." commented Glyn Edwards, Chief Executive Officer of Summit.  "Working via a new mechanism of action, SMT 19969 combines high bactericidal activity against C. difficile with exquisite selectivity by having minimal impact on the healthy bacteria that comprises the gut flora.  We are very excited about the potential of this antibiotic to become an effective treatment for this life threatening disease."

The presentations will be part of the session titled 'New antibacterial agents other than beta-lactams' that will be held at 13:30 CET on 28 April.  Further details about the three presentations are below and the full abstracts are available online at www.congrex.ch/eccmid2013/programme.

SMT19969: In vitro and in vivo evaluation of a novel antibiotic for Clostridium difficile infection

R. Vickers*, R. Storer, J. Tinsley, F. Wilson, M. Wilcox, S. Baines, J. Freeman, W. Weiss, M. Pulse, I. Morrissey, K. Maher (Poster # 1655)

In a range of studies SMT19969 was shown to be highly and selectively active against C. difficile. These data suggest SMT 19969 would have minimal deleterious effect on the human gut flora during CDI therapy which may have benefit in reducing rates of recurrent disease.

In vitro pharmacodynamics of the novel antibiotic SMT19969 against Clostridium difficile

D. Corbett*, A. Wise, L. Payne, R. Vickers, P. Warn (Poster # 1654)

Results from in vitro studies show SMT19969 is bactericidal resulting in almost total clearance of bacteria after 24h. SMT19969 demonstrates prolonged Post Antibiotic Effect at 5x Minimum Inhibition Concentration ('MIC') that results in bactericidal activity after 3 hours exposure. Maximum clinical efficacy of SMT19969 is likely to occur following exposure of >5x MIC for 3 hours with data from pharmacokinetic studies demonstrating this is readily achieved in the GI tract following oral dosing.

SMT19969: Preclinical safety and pharmacokinetics of a novel antimicrobial for Clostridium difficile infection

R. Vickers*, R. Storer, J. Tinsley, F. Wilson, N. Robinson (Poster # 1656)

Results of data from GLP studies assessing the toxicology, pharmacokinetics and distribution of SMT19969 that showed the novel antibiotic to be safe and well tolerated and permitted initiation of Phase I clinical trials.

About C. difficile Infection

C. difficile infection ('CDI') is a serious healthcare threat in hospitals, long-term care homes and increasingly the wider community.  It is a serious illness that is caused by infection of the colon by the bacteria C. difficile, which produces toxins that cause inflammation, severe diarrhoea and in the most serious cases can be fatal.  Patients typically develop CDI following the use of broad-spectrum antibiotics that disrupt the normal gastrointestinal (gut) flora and so allow the C. difficile bacteria to flourish.  Existing CDI antibiotics cause further damage to the gut flora and are associated with recurrent disease.  This is the key clinical issue as repeat episodes are typically more severe and associated with an increase in mortality rates and healthcare costs.

SMT 19969 is a novel, oral small molecule antibiotic that is being specifically developed for the treatment of CDI.  Results from non-clinical efficacy studies show that SMT 19969 combines potent activity against C. difficile with exceptionally high levels of antibacterial selectivity.  This narrow spectrum antibiotic has displayed efficacy in two key disease models while showing complete protection against recurrent disease.  SMT 19969 is targeted to the GI tract, the site of infection, and has exceptionally low levels of resistance development coupled with an excellent safety profile.

ECCMID takes place annually in the spring and is recognised by academia, the clinical setting and industry as the largest European congress for the presentation and discussion of research in the fields of clinical microbiology and infection.  The congress is organised by the European Society of Clinical Microbiology and Infectious Diseases.  Further information is available at www.escmid.org.

About the Wellcome Trust

The Wellcome Trust is a global charitable foundation dedicated to achieving extraordinary improvements in human and animal health. It supports the brightest minds in biomedical research and the medical humanities. The Trust's breadth of support includes public engagement, education and the application of research to improve health. It is independent of both political and commercial interests.  www.wellcome.ac.uk

Summit is an Oxford, UK based drug discovery and development Company targeting high-value areas of unmet medical need including Duchenne Muscular Dystrophy and C. difficile infection.  Summit is listed on the AIM market of the London Stock Exchange and trades under the ticker symbol SUMM. Further information is available at www.summitplc.com and follow Summit on Twitter (@summitplc).

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Forward Looking Statements

This announcement contains "forward-looking statements", including, but not limited to, statements about the discovery, development and commercialisation of programme assets. These forward-looking statements are statements based on the Company's current intentions, beliefs and expectations, which include, among other things, the Company's results of operations, financial condition, prospects, growth, strategies and the industry in which the Company operates. No forward-looking statement is a guarantee of future performance and actual results could differ materially from those expressed or implied in the forward-looking statements. Accordingly, readers should not place undue reliance on forward-looking statements or information.  Forward-looking statements and information by their nature involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements or information. These include but are not limited to: adverse results in clinical or preclinical development studies; delays in obtaining regulatory approval; failure to obtain patent protection for inventions; commercial limitations imposed by patents owned or controlled by third parties; being unable to secure partnership agreements to develop and commercialise programme assets; being unable to secure the necessary funding to conduct any proposed research and development studies; and the ability to retain and recruit key personnel.  The Company expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statement contained in this announcement to reflect any changes in expectations with regard thereto or any changes in events, conditions or circumstances on which any such statement is based, except as required by applicable law.