Finch Therapeutics Announces Results of CP101 for Prevention of Recurrent C. Difficile
PRISM-EXT shows data consistent with those of PRISM3, which provided significant improvement compared with the placebo through 8 weeks and 24 weeks post-treatment.
Finch Therapeutics Group Inc has announced positive topline results from PRISM-EXT, an open-label extension of the company’s PRISM4 phase 3 trial, evaluating CP101 for the prevention of recurrent C. difficile infection (CDI).
“The robust PRISM-EXT topline results add to the growing body of evidence supporting the potential for CP101 to meet the need for a convenient, orally administered therapeutic that can prevent recurrent C. difficile infection,” Jessica Allegretti, MD, MPH, principal investigator in the PRISM-EXT and PRISM3 trials at Brigham and Women’s Hospital in Boston, Massachusetts, said in a statement via email. “I am excited to participate in the ongoing evaluation of this novel therapeutic candidate.”
About 80% of individuals who received a single dose of CP101 following standard-of-care antibiotics achieved a sustained clinical cure through week 8. At week 24, 78.8% of individuals sustained a clinical cure.
The results build on and were consistent with the previous reported results of PRISM3 that showed that CP101 provided statistically significant improvement of the prevention of recurrent CDI compared with the placebo through 8 weeks and 24 weeks post-treatment.
There were no reported serious adverse events, and CP101 exhibited a consistent safety profile observed in PRISM3. The primary efficacy endpoint was a sustained clinical cure through 8 weeks post-treatment.
PRISM-EXT was a 24-week trial to evaluate the efficacy and safety of CP101 for the prevention of recurrent CDI in 132 individuals who either directly enrolled without participating in PRISM3 (82) or rolled over from PRISM3 after experiencing a CDI recurrence (50 individuals).
Finch Therapeutics announces positive topline results from PRISM-EXT Phase 2 trial of CP101 for prevention of recurrent C. difficileinfection. News release. November 9, 2021. Accessed November 10, 2021. Email.