Summit Therapeutics Announces Phase 3 Ri-CoDIFy Study of Ridinilazole

Summit Therapeutics announced topline results from the Phase III Ri-CoDIFy study evaluating ridinilazole for the treatment of and Sustained Clinical Response (SCR) for patients suffering from C. difficile infection (C. diff. infection or CDI). The study showed that ridinilazole resulted in a higher observed SCR rate than vancomycin but did not meet the study’s primary endpoint for superiority. SCR is defined as Clinical Response of the treated episode of CDI and no recurrence of the infection through 30 days after the end of treatment. Patients treated with ridinilazole experienced substantially less recurrence of C. diff. infection as compared to patients administered vancomycin. In this study recurrence was defined as a new episode of diarrhea (?3 unformed bowel movements) in a 1-day period with a positive C. difficile test that requires CDI antimicrobial treatment in subjects who achieved Clinical Response.