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Update on phase III Trial of CP 101 in recurrent C. difficile infection.-Finch Therapeutics Group.

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Published:6th Mar 2022

Finch Therapeutics Group, Inc. announced that it has paused enrollment in PRISM 4, its Phase III clinical trial of CP 101 in recurrent C. difficile infection (CDI) following receipt of a clinical hold letter from the FDA on February 24, 2022, requesting additional information about Finch’s SARS-CoV-2 donor screening protocols.

 

At the outset of the COVID-19 pandemic in March 2020, the FDA issued a public safety alert regarding the potential risk of transmission of SARS-CoV-2 virus through the use of donor-derived investigational microbiome therapies and the need for additional safety precautions. At that time, the FDA placed Finch’s investigational new drug application (IND) for CP 101 and the IND of its then-contract manufacturer, OpenBiome, on partial clinical hold, requiring the implementation of SARS-CoV-2 testing protocols for any microbiota material donated on or after December 1, 2019.

Notwithstanding the partial clinical hold notices, Finch was able to continue dosing patients in its then-ongoing PRISM-EXT Phase II open-label trial of CP 101 in recurrent CDI as all of the CP 101 lots used for PRISM-EXT were manufactured from material donated prior to December 1, 2019.

In January 2021, Finch’s then-contract manufacturer, OpenBiome, was released from clinical hold after implementing a direct testing method for SARS-CoV-2 provided by a third-party vendor. In March 2021, Finch acquired certain manufacturing assets from OpenBiome, and in November 2021, began dosing participants in PRISM4 with CP 101 lots that had been screened for SARS-CoV-2 using the same test method and vendor used by OpenBiome.

Following communications with FDA in January 2022, on February 24, 2022, 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 until the FDA’s requests have been satisfactorily addressed.

Finch has informed the FDA that participants were dosed in PRISM4 while the clinical hold was in effect and Finch is conducting a review of the matter. In their letter the FDA requested, among other things, additional detail on how samples are shipped to the vendor performing the SARS-CoV-2 testing and how inconclusive test results will be handled. The letter did not reference any adverse clinical outcome experienced in any of Finch’s clinical trials.

Finch expects to expeditiously provide the requested information and intends to work closely with the FDA to resolve the clinical hold as soon as possible. Finch is evaluating what impact, if any, the clinical hold may have on the timing of the expected readout of topline data from the PRISM4 trial.

Condition: Infectious Diseases/Clostridium
Type: drug

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