SOMERVILLE, Mass.–(BUSINESS WIRE)–Finch Therapeutics Group, Inc. (“Finch”), a clinical-stage microbiome drug development company, announced today that data from its positive PRISM3 trial with CP101, an investigational oral microbiome drug, were accepted as late-breaking abstracts for oral presentation at the United European Gastroenterology Week (UEGW) and the American College of Gastroenterology (ACG) Annual Scientific Meeting, two leading gastroenterology conferences that will be held this month.
The results presented at the medical conferences will build upon the positive PRISM3 results recently reported in June, which demonstrated that CP101 met the primary efficacy endpoint with a statistically significant improvement in sustained clinical cure compared to placebo. PRISM3 is a randomized, placebo-controlled, multi-center trial and is currently the only positive, placebo-controlled trial of an oral microbiome drug to include participants as early as their first CDI recurrence and participants with any guideline-approved method of CDI diagnosis at study entry.
UEGW is the largest scientific conference for gastroenterologists in Europe and is being held virtually from October 11-13. The PRISM3 results will be featured in an oral presentation on October 12 at 3:36 PM CEST. The abstract (#LB21) is titled “An Investigational Oral Microbiome Drug, CP101, for the Prevention of Recurrent C. difficile Infection: A Randomized, Placebo-Controlled, Multi-Center Trial (PRISM3).” ACG Annual Scientific Meeting is the premier clinical congress for gastroenterologists in the United States and is being held virtually from October 23-28. The PRISM3 results will be featured in an oral presentation on October 26 at 8:42 AM ET. The abstract (#LB2) has the same title as at UEGW.
“We are thrilled to share the results of the PRISM3 trial and pleased the abstracts were selected for oral presentation at these two important clinical conferences,” said Zain Kassam, MD, MPH, Chief Medical Officer of Finch. “Recurrent C. difficile is an urgent public health threat and severely impacts patients and their families. Intervening early is key to preventing the devastating effects, which is why we felt it was critical to evaluate the use of CP101 early in the disease cycle. We look forward to sharing these important results and continuing to partner with clinicians and patients in the fight against C. difficile.”
CP101 is an investigational, oral microbiome drug that Finch is developing for conditions linked to microbiome dysfunction. With 42 billion doses of antibiotics administered globally each year, resulting in widespread damage to the microbiome, research suggests that microbiome dysfunction is associated with the pathogenesis of a wide range of serious medical conditions. CP101 is designed to deliver complete microbiome communities in orally administered, enteric release capsules. CP101 is rigorously tested and manufactured under Good Manufacturing Practices (GMP) conditions. CP101 is in late-stage clinical development for the prevention of recurrent C. difficile infection. Finch plans to deploy CP101 to other conditions linked to microbiome disruption, starting with the evaluation of CP101 as a treatment for chronic hepatitis B.
About Finch Therapeutics
Finch Therapeutics is developing novel microbiome drugs to serve patients with serious unmet medical needs. Finch’s Human-First Discovery® platform enables reverse translation from clinical data to engineer the composition of the microbiome based on disease-modifying mechanisms. Finch’s platform uniquely enables development of both complete microbiome communities and rationally selected consortia to restore microbiome functionality and resolve conditions driven by dysbiosis, or disruption of the microbiome. Finch’s lead program, CP101, is an investigational oral microbiome drug with Fast Track and Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for the prevention of recurrent C. difficile infection. The company is also developing FIN-211 for the treatment of children with autism spectrum disorder and CP101 for the treatment of chronic hepatitis B. The company has a strategic partnership with Takeda Pharmaceuticals focused on the development of microbiome drugs for inflammatory bowel diseases.