U.S. FDA removes Clinical Hold on Finch's investigational new drug (IND) application for CP101

The U.S. Food and Drug Administration (FDA) has removed the clinical hold on Finch Therapeutics Group FNCH investigational new drug (IND) application for CP101 in  the prevention of recurrent C. difficile infection (CDI).

The regulatory agency lifted the clinical hold following a review of information Finch provided related to its SARS-CoV-2 screening procedures and associated informed consent language.

Finch submitted investigational new drug (IND) application in PRISM4, phase 3 study investigating CP101 in recurrent C. difficile infection.

Finch anticipates to proceed with enrollment in PRISM4 after it completes certain manufacturing activities and quality updates regarding the clinical hold and push the details to FDA for review.

Mark Smith, PhD, Chief Executive Officer, commented, “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”.

Additionally, The company planning to provide an update on the PRISM4 trial and its planned AUSPIRE Phase 1b trial of FIN-211 in children with autism spectrum disorder while reporting first quarter 2022 results.

Finch is currently trading up 32 percent at $2.77 in the after hours.