Positive results from randomized controlled trial of CP1 01, an oral microbiome drug, for the prevention of recurrent C. difficile infection.-Finch Therapeutics Group

Finch Therapeutics Group, Inc. announced positive topline results from PRISM3, its multi-center, randomized, double-blind, placebo-controlled Phase II trial of CP 101 , an investigational oral microbiome drug, for the prevention of recurrent C. difficile infection (CDI). In the PRISM3 trial, CP 101 met the primary efficacy endpoint, with 74.5% of recurrent CDI patients who received a single administration of CP 101 achieving a sustained clinical cure through week eight, a statistically significant improvement in comparison to 61.5% of patients in the control group who received standard-of-care antibiotic therapy alone (p < 0.05).

CP 101 was well-tolerated in the study at eight weeks post treatment, with no treatment-related serious adverse events. PRISM3 randomized 206 patients with recurrent CDI at 51 sites across the U.S. and Canada, representing the largest placebo-controlled trial to date of an oral microbiome drug. CP 101 is the first oral microbiome drug to meet its primary endpoint in a pivotal trial.

PRISM3 Trial and CP 101 Oral Administration Advance the Microbiome Field : PRISM3 participants received a one-time oral administration of CP 101 or placebo, following a course of standard-of-care CDI antibiotic therapy, which all patients received. Participants in the trial included patients experiencing their first recurrence of CDI, enabling the evaluation of CP 101 as an early intervention in the course of this debilitating and life-threatening disease, enhancing the clinical relevance of the trial. The study included patients diagnosed with CDI by polymerase chain reaction (PCR) or toxin enzyme immunoassay (EIA) laboratory testing, reflecting real-world clinical practices for detecting CDI. The primary endpoint of the trial is defined as the absence of CDI through eight weeks following treatment. After the eight-week period evaluating the primary efficacy endpoint, patients in the trial are being followed for an additional 16 weeks for additional safety and efficacy endpoints. Finch plans to present the full results of the study at an upcoming medical conference.

CP 101 builds on the significant body of evidence that microbiome restoration via microbiota transplantation procedures can prevent recurrent CDI. Unlike antibiotics, which inhibit C. difficile growth but do not restore the function of the microbiome, CP 101 is designed to prevent recurrent CDI by restoring colonization resistance, or the ability of a healthy microbiome to prevent colonization of potential pathogens. As an oral microbiome drug with rigorous testing that is manufactured under Good Manufacturing Practices (GMP) conditions, CP 101 is designed to achieve an improved safety profile, while delivering the full diversity of a healthy microbiome and improving the patient experience.