Summit Announces First Patients Dosed in a Phase 2 Clinical Trial of Novel C. difficile Antibiotic

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July 03, 2014 02:00 ET

Summit Therapeutics plc

Summit Therapeutics plc

Summit Corporation plc

('Summit' or the 'Company')

SUMMIT ANNOUNCES FIRST PATIENTS DOSED IN A PHASE 2 CLINICAL TRIAL OF THE NOVEL ANTIBIOTIC SMT19969 FOR THE TREATMENT OF C. DIFFICILE INFECTION

Oxford, UK, 3 July 2014 - Summit (AIM: SUMM), a drug discovery and development company advancing therapies for Duchenne Muscular Dystrophy and C. difficile infection ('CDI'), announces that the first patients have been dosed in its Phase 2 proof of concept clinical trial that is evaluating the novel oral antibiotic SMT19969 for the treatment of CDI.

"SMT19969 is a new and differentiated antibiotic that combines excellent potency with unprecedented selectivity for C. difficile meaning it has a minimal antibiotic effect against bacteria that comprise the healthy gut flora.  This profile is expected to be important in treating initial infection and reducing the high rates of disease recurrence, the major clinical issue that effects up to 30% of patients," commented Glyn Edwards, Chief Executive Officer of Summit.  "The enrolment and dosing of the first patients in this Phase 2 trial achieves another important development milestone on the path towards establishing proof of concept for this highly promising treatment."

About the Phase 2 Clinical Trial

The Phase 2 trial, named CoDIFy, is a randomised, double-blind, active comparator study that will evaluate the efficacy of SMT19969 relative to vancomycin, the current standard of care in the treatment of CDI following ten days of dosing.  The primary endpoint of the trial will measure the sustained clinical response, which is defined as cure from the initial infection with no recurrence within 30 days post end of treatment.   The safety and tolerability of SMT19969 will also be evaluated.  The study will recruit approximately 100 patients randomised into two equally sized treatment arms receiving SMT19969 and vancomycin respectively.

The study is being performed in North America and will involve approximately 25 trial sites in the US.  Summit has now received clearance from Health Canada regarding its Clinical Trial Application which adds up to five additional study sites in Canada.  Top line data from this trial is expected to be reported in the first half of 2015.  Further information about this study is available on www.clinicaltrials.gov.

The development of SMT19969 is being supported by a Translational Award from the Wellcome Trust.

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 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 C. difficile to flourish.  Existing CDI antibiotics cause further damage to the gut flora and are associated with high rates of 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.

Recent years have seen a significant increase in CDI and it is estimated that there are approximately 900,000 cases across Europe and North America per annum. This rise means CDI has a high economic burden with the annual cost of care in the US alone estimated at over $4.8 billion.

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 quoted 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 Summit can be followed 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.