Summit Corporation PLC : Initiation of Phase 1 Clinical Trial of Antibiotic to Treat C. difficile Infection

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October 31, 2012 03:00 ET

Summit Therapeutics plc

Summit Therapeutics plc

Summit Corporation plc

('Summit' or 'the Company')

SUMMIT ANNOUNCE INITIATION OF PHASE 1 CLINICAL TRIAL OF SELECTIVE ORAL ANTIBIOTIC FOR THE TREATMENT OF C. DIFFICILE INFECTION

Oxford, UK, 31 October 2012 - Summit (AIM: SUMM), a UK drug discovery company, announces that it has initiated  dosing of healthy volunteers in the Phase 1 clinical trial of SMT 19969, the novel, oral small molecule being developed as a selective antibiotic for the treatment of infections caused by the bacteria C. difficile.  The trial is being supported as part of a £4.0m Translation Award from the Wellcome Trust.

"C. difficile infection remains a serious illness in hospitals, long-term care homes and increasingly the wider community, and current treatment options remain limited," commented Glyn Edwards, Chief Executive Officer of Summit.  "Our novel antibiotic SMT 19969 is a selective treatment of C. difficile infection and we are very excited about advancing this promising drug into human clinical trials."

The Phase 1 trial is a randomised, dose-escalating, placebo-controlled study that will evaluate the safety, tolerability and pharmacokinetics of SMT 19969.  The study will enrol 56 healthy volunteers who will be divided into several cohorts and will receive single ascending doses and multiple ascending doses of SMT 19969. Headline results from the Phase 1 trial are expected to be reported in H1 2013.

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.

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).

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

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