Finch Therapeutics lifted by top-line results from Phase II trial of CP101

USA-based Finch Therapeutics (Nasdaq: FNCH), a specialist in oral biologics, today announced positive top-line results from PRISM-EXT, an open-label extension of the company’s PRISM3 Phase II placebo-controlled trial evaluating CP101 for the prevention of recurrent C. difficile infection (CDI), with the news edging the firm’s shares of nearly 3% to $15.26.

PRISM-EXT was a 24-week trial that evaluated the safety and efficacy of CP101 for the prevention of recurrent CDI 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). In the PRISM-EXT trial, there were no treatment-related serious adverse events reported and CP101 exhibited an overall safety profile consistent with the profile observed in PRISM3.

The primary efficacy endpoint was sustained clinical cure (defined as absence of CDI recurrence) through eight weeks post-treatment. Overall, 80.3% of participants who received a single oral administration of CP101 following standard-of-care (SOC) antibiotics in PRISM-EXT achieved sustained clinical cure through week 8. At week 24, 78.8% of participants had sustained clinical cure. The PRISM-EXT results are consistent with and build on the previously reported PRISM3 results, which showed that CP101 provided a statistically significant improvement in the prevention of recurrent CDI compared to placebo through 8 weeks and 24 weeks post-treatment.