Finch Phase 3 C. Diff Trial Still on Hold: FDA

FDA has told Finch Therapeutics that a clinical hold remains in place on its Phase 3 trial of CP101 in recurrent C. difficile infection. The company says an agency 2/24 letter said it needed additional information about Finch’s SARA-CoV-2 donor screening protocols.

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 has now 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.

“The letter did not reference any adverse clinical outcomes experienced in any of Finch’s clinical trials,” the company says. It says it expects to expeditiously provide the requested information and intends to work closely with FDA to resolve the clinical hold as soon as possible.