Summit Therapeutics Receives FDA Fast Track Designation for Novel Antibiotic SMT19969 in the Treatment of C. difficile Infection

Summit Therapeutics plc SUMM SMMT, the drug discovery and development company advancing therapies for Duchenne muscular dystrophy and C. difficile infection ('CDI'), announces that the US Food and Drug Administration ('FDA') has granted Fast Track designation for the Company's novel antibiotic for the treatment of CDI. SMT19969 is a highly selective antibiotic candidate currently being evaluated in a Phase 2 proof of concept trial in CDI patients in North America. "Fast Track designation recognizes the serious healthcare threat posed by C. difficile due to a high rate of disease recurrence, the key clinical issue in treating CDI, and underscores the importance of developing a candidate like SMT19969, which has significant potential to address both the initial infection and recurrence," said Glyn Edwards, Chief Executive Officer of Summit. Fast Track designation is awarded to expedite the development and regulatory review of drugs intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. SMT19969 is also designated a Qualified Infectious Disease Product ('QIDP') under the Generating Antibiotic Incentives Now Act ('GAIN Act'), which allows Summit to benefit from a number of incentives supporting development of new antibiotics, and if SMT19969 receives marketing approval from FDA, a five year extension of market exclusivity.