OXFORD, UK I September 10, 2015 I Summit Therapeutics plc (SMMT) (SUMM.L), the drug discovery and development company advancing therapies for Duchenne muscular dystrophy (‘DMD’) and Clostridium difficile infection (‘CDI’), today announced the completion of patient enrolment into the CoDIFy Phase 2 proof of concept trial of SMT19969 for the treatment of CDI. Patient dosing and follow-up is continuing and top-line results are expected in the fourth quarter of 2015. SMT19969 is a novel, oral antibiotic designed to selectively target C. difficile bacteria while not harming the gut microbiome that is essential in protecting against disease recurrence.

“CDI is now widely accepted to be a major healthcare issue, and with current antibiotics used to treat CDI having high rates of disease recurrence, there is an urgent need to develop new therapies,” said Glyn Edwards, Chief Executive Officer of Summit. “We believe SMT19969 represents an important advance as its potency in killing C. difficile bacteria is complemented by selective targeting that leaves the healthy gut microbiome unharmed. The timely completion of enrolment into our CoDIFy proof of concept trial achieves an important milestone and means we remain on-track to report top-line results in the fourth quarter of this year.”

C. difficile is one of three pathogens that pose an immediate public health threat according to the US Center for Disease Control and Prevention (‘CDC’). CDI has a high economic impact with annual acute care costs estimated at $4.8 billion in the United States alone. The key clinical issue is disease recurrence with approximately 25% of patients suffering recurrence of CDI, a risk that rises to 40% after a first recurrence and over 65% after a second recurrence.

SMT19969 has received Qualified Infectious Disease Product designation (‘QIDP’) and Fast Track status from the US Food and Drug Administration. The development of SMT19969 is being supported by a Wellcome Trust Translational Award.

About CoDIFy Phase 2 Clinical Trial

CoDIFy, is a double-blind, randomized, active control Phase 2 trial evaluating the efficacy of SMT19969 against the current standard of care, vancomycin. CoDIFy is being conducted in the United States and Canada. The trial has enrolled a total of 100 patients, with half receiving ten days of dosing with SMT19969, and half receiving ten days of dosing with vancomycin. The primary endpoint of the trial is sustained clinical response, a composite endpoint which is defined as clinical cure at the test of cure visit with no recurrence of CDI within 30 days after the end of treatment. The trial is also examining a number of secondary endpoints, including the safety and tolerability of SMT19969 and its impact on patients’ gut microbiome.

About SMT19969

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 high levels of antibacterial selectivity. A Phase 1 trial conducted in healthy volunteers showed SMT19969 to be well tolerated at all doses tested. In addition, a significant reduction in total clostridia but not in other bacterial groups was reported, demonstrating that SMT19969 was highly sparing of the gut microbiome.

About Summit Therapeutics

Summit is a biopharmaceutical company focused on the discovery, development and commercialization of novel medicines for indications for which there are no existing or only inadequate therapies. Summit is conducting clinical programs focused on the genetic disease Duchenne muscular dystrophy and the infectious disease C. difficile infection. Further information is available at www.summitplc.com and Summit can be followed on Twitter (@summitplc).

SOURCE: Summit Therapeutics