Finch Therapeutics Announces Removal of FDA Clinical Hold on CP101 IND
SOMERVILLE, Mass., April 28, 2022 (GLOBE NEWSWIRE) -- Finch Therapeutics Group, Inc. (“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 that the U.S. Food and Drug Administration (FDA) has removed the clinical hold on Finch’s investigational new drug (IND) application for CP101. CP101 is the Company’s investigational orally administered microbiome therapeutic which is in late-stage clinical development for the prevention of recurrent C. difficile infection (CDI). The FDA lifted the clinical hold following a review of information Finch provided related to its SARS-CoV-2 screening procedures and associated informed consent language.
“We are grateful that the FDA has completed its review of the information we provided, and we are pleased that the clinical hold on our CP101 IND has been lifted,” said Mark Smith, PhD, Chief Executive Officer of Finch Therapeutics. “We look forward to completing the additional activities that we believe will enable us to proceed with enrollment in PRISM4, our Phase 3 study of CP101 in recurrent C. difficile infection, and we thank our PRISM4 trial partners for their continued support and dedication to serving patients who are battling recurrent C. difficile infection.”
Finch expects to proceed with enrollment in PRISM4 after it completes certain manufacturing activities and quality system updates related to the recently resolved clinical hold, and submits for the FDA’s review and agreement the validation package for one of its release tests and a PRISM4 protocol amendment. The PRISM4 protocol amendment will implement changes to the algorithm used to diagnose suspected CDI recurrences and revisions to the planned statistical analysis. In parallel with these activities, Finch will continue to work with its PRISM4 trial sites to prepare for enrollment.
Finch plans to provide an update on the anticipated timing of both its PRISM4 trial and its planned AUSPIRE Phase 1b trial of FIN-211 in children with autism spectrum disorder and significant gastrointestinal symptoms when the Company reports its first quarter 2022 results.
About Finch Therapeutics
Finch Therapeutics is a clinical-stage microbiome therapeutics company leveraging its Human-First Discovery® platform to develop a novel class of orally administered biological drugs. With the capabilities to develop both complete and targeted microbiome therapeutics, Finch is advancing a rich pipeline of candidates designed to address a wide range of unmet medical needs. Finch’s lead candidate, CP101, is in late-stage clinical development for the prevention of recurrent C. difficile infection and has received Breakthrough Therapy and Fast Track designations from the U.S. Food and Drug Administration. Finch is also developing FIN-211 for children with autism spectrum disorder and significant gastrointestinal symptoms. Finch has a partnership with Takeda focused on the development of targeted microbiome therapeutics for inflammatory bowel disease.
Human-First Discovery® is a registered trademark of Finch Therapeutics Group, Inc.
