Summit Therapeutics Seeks Partnership For Phase 3 Infection Candidate Development
- In an SEC filing, Summit Therapeutics Inc said it would seek partners or divestiture of ridinilazole as the path forward for the clinical development of the asset.
- Ridinilazole is the company’s Phase 3 product candidate for Clostridioides difficile infection (C. diff. infection or CDI).
- As a result of this determination, the company will discontinue its only active study for ridinilazole, a pediatric clinical trial evaluating ridinilazole, for treating adolescent patients with CDI.
- As previously communicated, the company held a Type C meeting with the FDA, during which the FDA and Summit discussed a possible pathway to advance ridinilazole to achieve marketing authorization.
- This pathway would involve at least one additional registrational trial, for which Summit will seek a partner to perform.
- Further, the company plans to present the data associated with ridinilazole's Phase 3 clinical trial, Ri-CoDIFy, at IDWeek 2022 later this month.
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