![]() difficile, putting patients at high risk for recurrence. Standard-of-care antibiotics effectively treat the active infection, but most antibiotics disrupt the intestinal microbiome and its ability to fight off C. ![]() difficile become trapped in repeating cycles of infection. “A proportion of patients who contract C. difficile infection,” said Sahil Khanna, MBBS, Co-Investigator in the PRISM-EXT and PRISM3 trials at the Mayo Clinic in Rochester. “These data provide hope to patients suffering from recurrent C. Finch plans to present additional data from PRISM-EXT at a future medical conference. In PRISM-EXT, treatment-related adverse events were of mild to moderate severity, and primarily gastrointestinal in nature, with no treatment-related serious adverse events reported through week 24. ![]() Of the participants who received either a single dose of CP101 in PRISM3 (n=82) or a second dose by enrolling in PRISM-EXT (n=20), a post-hoc analysis shows that a total of 90 participants achieved sustained clinical cure through 8 weeks after their final dose, resulting in a cumulative efficacy of 88.2% (n=102). There were two cohorts of participants one cohort directly enrolled in the trial following a recent CDI recurrence without having previously participated in PRISM3 (n=82) and one cohort enrolled after experiencing a CDI recurrence following administration of placebo or a single dose of CP101 in PRISM3 (n=50).Īmong the 102 participants who were treated with CP101 in PRISM3, 20 were enrolled in PRISM-EXT and treated with a second dose of CP101. Following successful completion of SOC antibiotics, participants were treated with a single oral administration of CP101 without bowel preparation. PRISM-EXT enrolled adults of any age with one or more CDI recurrences. Participants were followed for a total of 24 weeks for safety and sustained clinical cure. ![]() The primary endpoints were safety and sustained clinical cure (absence of CDI recurrence) through 8 weeks post-treatment. The PRISM-EXT trial was a multi-center, open-label extension of the PRISM3 Phase 2 randomized, placebo-controlled trial evaluating CP101 for the prevention of recurrent CDI. PRISM-EXT Trial Design and Additional Results 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. At week 24, 78.8% of participants had sustained clinical cure. 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. The primary efficacy endpoint was sustained clinical cure (defined as absence of CDI recurrence) through eight weeks post-treatment. 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. 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). (“Finch” or “Finch Therapeutics”) (Nasdaq: FNCH), a clinical-stage microbiome therapeutics company leveraging its Human-First Discovery ® platform to develop a novel class of orally administered biological drugs, today announced positive topline results from PRISM-EXT, an open-label extension of the company’s PRISM3 Phase 2 placebo-controlled trial evaluating CP101 for the prevention of recurrent C. 09, 2021 (GLOBE NEWSWIRE) - Finch Therapeutics Group, Inc. New data from 132-participant PRISM-EXT Phase 2 open-label trial show 80.3% sustained clinical cure rate through 8 weeks, with a similar rate maintained through 24 weeks and a safety profile consistent with previously reported dataĪggregated 88.2% sustained clinical cure rate shown through 8 weeks following last dose in post-hoc analysis of participants that received up to two doses of CP101 in PRISM3 and PRISM-EXT trialsįinch also announces start of enrollment in PRISM4 Phase 3 trial
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