- The FDA has issued a clinical hold letter to Finch Therapeutics Group Inc's (NASDAQ:FNCH) PRISM4 Phase 3 trial of CP101 in recurrent C. difficile infection (CDI).
- The Company has paused enrollment in the trial as the FDA has asked for additional information about Finch's SARS-CoV-2 donor screening protocols.
- The FDA placed Finch's investigational new drug application (IND) for CP101 and the IND of its then-contract manufacturer, OpenBiome, on partial clinical hold in 2020, requiring the implementation of SARS-CoV-2 testing protocols for any microbiota material donated on or after December 1, 2019.
- Related: Finch Therapeutics' C. Difficile Infection Candidate Meets Primary Goal In Mid-Stage Study.
- Nevertheless, Finch continued dosing patients in its then-ongoing PRISM-EXT Phase 2 trial of CP101 in recurrent CDI. All CP101 lots used for PRISM-EXT were manufactured from material donated before December 1, 2019.
- Following communications with FDA in January, the FDA sent a letter stating that it needs additional information about Finch's SARS-CoV-2 screening protocols and that a clinical hold remains in effect.
- Finch has informed the FDA that participants were dosed in PRISM4 while the clinical hold was in effect, and it is conducting a review of the matter.
- The letter did not reference any adverse clinical outcome experienced in Finch's clinical trials.
- Price Action: FNCH shares closed 22.9% lower at $6.48 during after-hours trading on Tuesday.
