Phase 3 Trial Paused for CP101 in Recurrent C. difficle Infection

Enrollment has been paused for PRISM4, the phase 3 clinical trial of CP101(Finch Therapeutics Group, Inc) in recurrent Clostridioides difficile infection (CDI), following a letter from the FDA on February 24, 2022, requesting additional information about Finch Therapeutics’ SARS-CoV-2 donor screening protocols.

In March 2020, the FDA issued a public safety alert regarding the potential risk of transmission of SARS-CoV-2 virus using donor-derived investigational microbiome therapies and the need for additional safety precautions. Further, the FDA placed Finch’s investigational new drug application (IND) for CP101 and the IND of then-contract manufacturer, OpenBiome, on partial clinical hold, which requires the implementation of SARS-CoV-2 testing protocols for any microbiota material donated on or after December 1, 2019.

Finch was still able to continue dosing patients in its past-ongoing PRISM-EXT phase 2 open-label trial of CP101 in recurrent CDI, because the CP101 lots used for PRISM-EXT were manufactured from material donated prior to December 1, 2019.

OpenBiome was released from clinical hold after implementing a direct testing method for SARS-CoV-2 provided by a third-party vendor in January 2021. In March 2021, Finch obtained certain manufacturing assets from OpenBiome, following the start of dosing participants in PRISM4 with CP101 lots that had been screened for SARS-CoV-2 in November 2021.

After communications with the FDA in January 2022, on February 24, 2022, the FDA sent a letter outlining the needs for additional information about Finch’s SARS-CoV-2 screening protocols. The clinical hold remains in effect until the FDA’s requests have been satisfactorily addressed. Finch informed the FDA that participants were dosed in PRISM4 while the clinical hold was in effect and a review will be conducted.

Additional details on how samples are shipped to the vendor performing the SARS-CoV-2 testing and inconclusive test results were also highlighted in the letter to the FDA. However, the letter did not reference any adverse clinical outcome experienced in any of Finch’s clinical trials.

REFERENCE

Finch Therapeutics provides an update on its phase 3 trial of CP101 in recurrent C. difficle infection. Finch Therapeutics Group, Inc. March 1, 2022. Accessed March 10, 2022. https://ir.finchtherapeutics.com/news-releases/news-release-details/finch-therapeutics-provides-update-its-phase-3-trial-cp101#:~:text=(%E2%80%9CFinch%E2%80%9D%20or%20%E2%80%9CFinch,clinical%20trial%20of%20CP101%20in