Finch Therapeutics Shares Fall as CP101 Phase 3 Study on Hold

By Colin Kellaher

Shares of Finch Therapeutics Group Inc. fell more than 10% on Wednesday after the microbiome-therapeutics company said it had paused enrollment in a Phase 3 study of its lead product candidate amid a Food and Drug Administration clinical hold.

The Somerville, Mass., company, which is studying CP101 in recurrent C. difficile infection, said the FDA wants more information about its SARS-CoV-2 donor screening protocols.

The FDA had previously issued an alert at the outset of the Covid-19 pandemic in March 2020 regarding the potential risk of transmission of the SARS-CoV-2 virus through the use of donor-derived investigational microbiome therapies and the need for additional safety precautions.

Finch, which had begun dosing participants in the Phase 3 study in November, said it received a letter from the FDA stating that the agency needs more information about Finch's SARS-CoV-2 screening protocols, and that a clinical hold remains in effect until its requests have been satisfactorily addressed.

Finch said it will work to provide the requested information and resolve the hold as soon as possible, adding that it is evaluating what impact the hold may have on the timing of the expected readout of topline data from the study.

Finch shares were recently changing hands at $7.40, down 11.9%.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

March 02, 2022 12:05 ET (17:05 GMT)

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