- Summit Therapeutics Inc (NASDAQ:SMMT) provided an update on the clinical development of ridinilazole, its lead Phase 3 product candidate for Clostridioides difficile infection (C. diff. infection or CDI).
- This week, Summit and the FDA held a Type C meeting during which Summit discussed certain data from the Ri-CoDIFy Phase 3 trial.
- Related: Summit Therapeutics’ Infection Candidate Flunks In Head-To-Head Trial.
- The FDA and Summit discussed a possible pathway to advance ridinilazole to achieve marketing authorization. This pathway would involve reasonable efforts that would likely involve at least one additional clinical trial. The company plans to explore this possibility.
- The company also plans to share the results from Ri-CoDIFy Phase 3 trial through an oral abstract presentation at IDWeek 2022 in October.
- Price Action: SMMT shares are up 1.85% at $0.97 during the market session on the last check Thursday.
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Combination of PDS0101 and KEYTRUDA® appears to lead to changes towards a TH1 predominant cytokine profile reported to be associated with improved killer T cell activity
Lowered CD8 T cells in peripheral
