▎ WuXi AppTec content team editor
A few days ago, Finch Therapeutics announced that the US FDA has allowed its clinical trials of CP101, which focuses on oral microbiome therapy, to continue for the prevention of recurrent Clostridium difficile (C. difficile). difficile) infection (CDI). Because Finch's CP101 contains microbiomes derived from donor feces, during the COVID-19 pandemic, the FDA was concerned that feces could carry the new crown virus, adversely affecting subjects. After reviewing the information provided by Finch about the COVID-19 screening process and related informed consent content, the FDA agreed to allow clinical trials to proceed.
Clostridium difficile infection (CDI) is one of the threats to antibiotic-resistant bacteria. It is a gastrointestinal pathogen that causes life-threatening diarrhea. Although the first occurrence of CDI can usually be cured by antibiotic therapy, it is characterized by a high recurrence rate after standard antibiotic therapy, and as recurrence continues to appear, there are fewer and fewer antibiotic options that can treat CDI.
CP101 is an investigational oral microbiome drug. Studies have shown that intestinal microbiome dysfunction is associated with the pathogenesis of a range of serious diseases. CP101 delivers intact microbial communities in the form of oral enteric-coated capsules. It aims to prevent recurrent CDI by restoring colonization resistance, or a healthy microbiome, to prevent the colonization of potential pathogens. It has been granted fast-track qualification and breakthrough therapy accreditation by the U.S. FDA for the prevention of recurrent CDI.
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In a Phase 2 clinical trial called PRISM3, CP101 met the primary efficacy endpoint, with 74.5% of patients with recurrent CDI receiving a single dose of CP101 achieving sustained clinical cure at week 8, a statistically significant improvement compared to 61.5% of patients in the control group (pCP101 was well tolerated in the study with no treatment-related serious adverse events).
Finch plans to continue patient registration for its Phase 3 clinical trial, PRISM4, after completing some manufacturing activities and quality system updates, and submitting clinical trial process revisions to the FDA. The revised clinical trial process will modify the algorithm for diagnosing CDI recurrence as well as the planned statistical analysis.
Dr. Mark Smith, CEO of Finch Therapeutics
"We are pleased that the FDA has completed its review of the information we provided and has released clinical trials of CP101." Dr Mark Smith, CEO of Finch, said, "We look forward to completing the activities needed to allow us to continue PRISM4 patient registration, and we thank our partners in the PRISM4 clinical trial for their continued support." ”
Resources:
[1] Finch Therapeutics Announces Removal of FDA Clinical Hold on CP101 IND. Retrieved April 29, 2022, from https://ir.finchtherapeutics.com/news-releases/news-release-details/finch-therapeutics-announces-removal-fda-clinical-hold-cp101-ind
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