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# Clinical Hold Lifted on Finch C-diff Therapy
- URL: https://www.fdaweb.com/clinical-hold-lifted-on-finch-c-diff-therapy/
- Published: 2022-04-29T12:00:00.000Z
- Updated: 2026-09-14T17:42:41.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151710

FDA has lifted a clinical hold on a Finch Therapeutics Group IND for CP101, an orally administered microbiome therapeutic which is in late-stage clinical development for preventing 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,” the company says.

Since 3/2020 FDA has raised concerns about the risk of transmission of SARS-CoV-2 virus through the use of donor-derived investigational microbiome therapies and the need for additional safety precautions. FDA asked for additional details from Finch on how samples are shipped to a vendor performing the SARS-CoV-2 testing and how inconclusive test results will be handled.

“Finch expects to proceed with enrollment in our Phase 3 PRISM4 trial 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 on the validation package for one of its release tests and a PRISM4 protocol amendment,” according to the company. “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.”