- Finch Therapeutics Group Inc FNCH announced positive topline results from PRISM-EXT, an open-label extension of the PRISM3 Phase 2 trial evaluating CP101 to prevent recurrent C. difficile infection (CDI).
- PRISM-EXT was a 24-week trial in 132 participants who either rolled over from PRISM3 after experiencing a CDI recurrence (n=50) or directly enrolled after experiencing a CDI recurrence without previously participating in PRISM3 (n=82).
- The primary efficacy endpoint was sustained clinical cure through eight weeks post-treatment.
- Overall, 80.3% of participants who received a single administration of CP101 following standard-of-care (SOC) antibiotics achieved sustained clinical cure through week 8.
- At week 24, 78.8% of participants had sustained clinical cure.
- No treatment-related serious adverse events were reported in the PRISM-EXT trial, and CP101 exhibited an overall safety profile.
- Finch also announced the start of enrollment in the PRISM4 Phase 3 trial.
- Related Link: Takeda To Lead Finch-Partnered Microbiome IBD Drug.
- Price Action: FNCH shares closed 11.64% higher at $16.50 during after-hours trading on Tuesday.
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