Finch Therapeutics has been given the green light to continue the Phase III Prism4 clinical trial, investigating the efficacy of CP101 in fighting recurrent C. difficile infections (CDI).
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Massachusetts-based Finch Therapeutics has been given the green light to continue the Phase III Prism4 clinical trial, investigating the efficacy of CP101 in fighting recurrent C. difficile infections (CDI). A clinical hold was issued by the U.S. Food and Drug Administration in February. The therapeutic candidate previously received Breakthrough and Fast Track designations from the FDA.
The hold requested further elaboration on “how SARS-CoV-2 donor samples will be shipped to the vendor that will perform the testing, as well as how they would handle inconclusive results.” The pandemic’s impact on the clinical sector of pharma continues to unfold as the world adjusts, and Finch has not been spared.
The study (NCT05153499) will soon continue participant enrollment, following an internal evaluation of the company’s quality system and CP101 manufacturing activities. Continuation of the study will also require the FDA to review a protocol amendment, which includes an updated CDI diagnosis algorithm and validation of a release test. After the delay, the company has indicated that the Prism4 study timeline may shift accordingly.
Regarding the clinical hold lift, Finch CEO Mark Smith said, “We are grateful that the FDA has completed its review of the information we provided, and we are pleased that the clinical hold on our CP101 IND has been lifted. We look forward to completing the additional activities that we believe will enable us to proceed with enrollment in Prism4, our Phase III study of CP101 in recurrent C. difficile infection, and we thank our Prism4 trial partners for their continued support and dedication to serving patients who are battling recurrent C. difficile infection.”
CP101 is a unique therapeutic candidate, with an intention to replenish a patient’s microbiome with a complete set of functioning microorganisms. The therapeutic utilizes Finch’s Human-First Discovery platform that is designed to provide oral medications that address areas with unmet medical needs.
The Prism4 trial is randomized, double-blind and placebo-controlled. The primary outcomes include measurement of CDI recurrence at week eight through culture and/or a positive enzyme immunoassay (EIA). Secondary endpoint measurements will evaluate adverse event occurrence and CDI recurrence at week 24.
Prism4 is the company’s latest study to evaluate CP101 in patients with CDI. In the Prism3 study, efficacy was demonstrated, as 73.5% of participants in the CP101 arm were characterized as having a sustained clinical cure. The treatment was tolerated well, with no serious adverse events reported.
Previous roadblocks have hindered the final development steps for CP101. Earlier this month, Finch announced that the employee roster would need to be slashed by 20% to reallocate spending towards the development of CP101 and other candidates.
Shortly before the issuance of the FDA’s clinical hold, the company announced a restructuring that included instating a new chief development officer, Alka Batycky, Ph.D., and Howard Franklin, M.D., MBA as the company’s senior vice president for late-stage development and GI therapeutics.
