Menlo Park, California, July 14, 2022 – Summit Therapeutics Inc. (NASDAQ: SMMT) (“Summit,” “we,” or the “Company”) today provided an update with respect to the clinical development of ridinilazole, its lead Phase III product candidate for the treatment of patients with Clostridioides difficile infection (“C. diff. infection” or “CDI”).
This week, Summit and the US Food & Drug Administration (the “FDA”) held a Type C meeting during which Summit discussed certain data from the Ri-CoDIFy Phase III clinical trial with the agency. The FDA and Summit discussed a possible pathway in which to advance ridinilazole forward with the goal of achieving marketing authorization. This pathway would involve reasonable efforts that would likely involve at least one additional clinical trial.We plan to explore this possibility.
We also plan to share the results from our Ri-CoDIFy Phase III clinical trial through an oral abstract presentation at IDWeek 2022, a major medical conference scheduled to be held in Washington, DC in October. IDWeek is the joint annual meeting of the Infectious Diseases Society of America (IDSA), Society for Healthcare Epidemiology of America (SHEA), the HIV Medicine Association (HIVMA), the Pediatric Infectious Diseases Society (PIDS), and the Society of Infectious Diseases Pharmacists (SIDP).
Full PR available here