Summit Presents New Positive Non-Clinical Efficacy Data at ECCMID

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May 12, 2014 02:00 ET

Summit Therapeutics plc

Summit Therapeutics plc

Summit Corporation plc

('Summit' or 'the Company')

SUMMIT PRESENTS NEW POSITIVE NON-CLINICAL EFFICACY DATA AT THE 24TH European Congress of Clinical Microbiology and Infectious Disease (ECCMID)

Oxford, UK, 12 May 2014 - Summit (AIM: SUMM), a drug discovery and development company advancing therapies for Duchenne Muscular Dystrophy and C. difficile infection ('CDI'), reported new positive non-clinical efficacy data on SMT19969, the novel and selective antibiotic for the treatment of CDI, at the 24th European Congress of Clinical Microbiology and Infectious Disease ('ECCMID') being held in Barcelona, May 10-13 2014.

New data were presented from an in vivo efficacy study that compared SMT19969 with vancomycin and fidaxomicin (the only two FDA-approved antibiotics for CDI) in the treatment of infections by various C. difficile strains including the hyper-virulent ribotype 027.  The data showed that all three treatments provided 100% protection during the acute stages of infection.  SMT19969 provided significant protection from recurrent disease against both strains with survival rates of between 90-100%.  This was superior to vancomycin for both strains (survival rates of 10% or less), and superior to fidaxomicin against 012 (survival rate <50%) and comparable against 027.

"These results further illustrate that SMT19969 has the potential as a new and differentiated antibiotic for the treatment of initial CDI infection and prevention of recurrent disease, the key clinical issue," commented Glyn Edwards, Chief Executive Officer of Summit.  "Summit is excited about the future development of SMT19969 as we prepare to recruit patients into a Phase 2 proof of concept study that seeks to establish the potential of this highly selective antibiotic in the treatment of CDI."

A second poster summarized findings from the Phase 1 trial and in vitro microbiology studies, which demonstrate that SMT19969 offers potent activity against C. difficile with minimal impact on normal gut flora.  Summit and key collaborators made both presentations as part of the session titled 'C. difficile: Antimicrobial Susceptibility and Treatment' that was held at 13:30 CET on Sunday 11 May.  Further details are below and copies will shortly be available from www.summitplc.com.

SMT19969 for Clostridium difficile Infection: Comparative efficacy compared to fidaxomicin and vancomycin in the hamster model of CDI

Vickers R.; Teague J.; Thomas P.; Warn P.A. (Poster 0798)

Results of the in vivo study comparing SMT19969 with the two FDA approved antibiotics for CDI.  In addition to the efficacy data detailed above, SMT19969 resulted in complete clearance of C. difficile spores by day 7, superior to fidaxomicin and comparable to vancomycin. SMT19969 was also restricted to the GI tract, the site of infection.

SMT 19969: a novel agent for Clostridium difficile infection - summary results from in vitro microbiology and a randomised double blind phase 1 clinical trial

Vickers R.J.; Citron D.M.; Goldstein E.J.C.; Best E.L.; Wilcox M.H. (Poster 0801)

A presentation reporting data from the Phase 1 clinical trial in healthy volunteers completed in 2013 and in vitro microbiology data that demonstrates how SMT19969 combines potent bactericidal activity for C. difficile with minimal antibiotic effect against representative bacterial of normal gut flora.  This selectivity profile has the potential to treat of initial infection and prevention of recurrent disease.

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 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.

SMT19969 is a novel, oral small molecule antibiotic that is being developed specifically for the treatment of CDI. Results from non-clinical efficacy studies show that SMT19969 combines potent bactericidal activity against C. difficile with exceptionally high levels of antibacterial selectivity. This targeted antibiotic has displayed efficacy in two key disease models while showing complete protection from recurrent disease. A Phase 1 trial conducted in healthy volunteers showed SMT19969 to be safe and well tolerated at all doses tested.  In addition, a significant reduction in total clostridia but not in other bacterial groups was reported which demonstrated that SMT19969 was highly sparing of gut flora.  Summit received clearance from the FDA for its IND application to initiate a Phase 2 proof of concept trial in March 2014. The development of SMT19969 is being support by a translational award from the Wellcome Trust.

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.

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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