COVID-19, Manufacturing Challenges Trip up Finch's C. Difficile Trial
The US Food and Drug Administration has issued a clinical hold letter regarding Finch Therapeutics' Phase III PRISM4 trial, requiring the company to submit additional information on its screening protocols.
The letter, dated February 24, 2022, asked Finch to pause enrollment for the trial on CP101 in recurrent C. difficile infection, pending details 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.
Finch said it would cooperate closely with the FDA and provide all the needed data to lift the hold order as soon as possible. As of this writing, the company is still evaluating how the hold will affect the trial's timeline. The letter also reportedly only mentioned the lack of data and did not say anything about adverse reactions experienced during the trial.
In March 2020, the FDA had issued a warning on the possible risk of SARS-CoV-2 transmission in donor-derived investigational trials and called on companies to implement extra precautionary measures to prevent this.
At the time, Finch's investigational new drug application for CP101 was placed on partial clinical hold, alongside then-contract manufacturer OpenBiome, requiring the implementation of safety protocols for data collected on or after December 1, 2019. Despite the partial hold notice, Finch was still able to continue dosing patients in its then-active PRISM-EXT Phase II study of CP101 because all of the data used in this study were taken before the December 1 cutoff.
In January 2021, the hold on OpenBiome was lifted after it solved the issue using a direct-testing method via a third party provider. Finch then began dosing participants in the PRISM4 trial in November 2021. However, the latest FDA letter also notified Finch that the regulator would conduct a review of the trial's processes after Finch said it was dosing patients under the PRISM4 study while the hold was already in effect.
Finch is largely known for its Human-First Discovery platform, which aims to develop a new class of orally administered biological medications to address a wide range of unmet medical needs. CP101, its lead candidate, managed to meet its primary efficacy endpoint in the PRISM3 trial in June 2020.
The PRISM4 study is the second pivotal trial of the drug for recurrent CDI. The company is also developing CP101 for chronic hepatitis B and another product called FIN-211 for behavioral and gastrointestinal symptoms in children diagnosed with an autism spectrum disorder.
News of the FDA's hold letter comes just a few weeks after the company appointed new members of its leadership team, namely Bryan Gillis, MBA as chief technology officer, Alka Batycky, Ph.D., as chief development officer and Howard Franklin, MD, MBA as senior vice president for the late-stage development and GI therapeutic unit.