Express FDA releases, Phase 3 clinical trial of oral microbiome therapy is about to restart

▎WuXi AppTec Content Team Editor A few days ago, Finch Therapeutics announced that the U.
S.
Food and Drug Administration (FDA) has allowed its clinical trial of CP101, its main oral microbiome therapy, to continue for the prevention of recurrent Clostridium difficile (C.
difficile) infection (CDI)
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Because the microbiome contained in Finch's CP101 was derived from the feces of the donors, during the COVID-19 pandemic, the FDA was concerned that the feces could carry the new coronavirus and adversely affect subjects
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After reviewing information provided by Finch about the coronavirus screening process and related informed consent, the FDA agreed to allow the clinical trial to proceed
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Clostridium difficile infection (CDI) is one of the threats of antibiotic-resistant bacteria
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It is a gastrointestinal pathogen that causes life-threatening diarrhea
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Although initial CDI is usually curable with antibiotic therapy, it is characterized by a high rate of recurrence after standard antibiotic therapy, and as recurrences continue to occur, there are fewer and fewer antibiotic options available to treat CDI
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CP101 is an investigational oral microbiome drug
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Studies have shown that gut microbiome dysfunction is associated with the pathogenesis of a range of serious diseases
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CP101 delivers the complete microbial community in oral enteric-coated capsules
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Aims to prevent recurrent CDI by restoring colonization resistance, or the ability of a healthy microbiome to prevent colonization by potential pathogens
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It has received Fast Track designation and Breakthrough Therapy designation from the US FDA for the prevention of recurrent CDI
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Related reading: Ask for "gold" from "feces"! See how this company is "scouring" innovative microbiome therapies Image source: 123RF 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 in Sustained clinical cure was achieved at week 8, a statistically significant improvement (p<0.
05) compared with 61.
5% of control patients
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CP101 was well tolerated in the study with no treatment-related serious adverse events
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Finch plans to continue patient enrollment in its Phase 3 clinical trial PRISM4 after completing some manufacturing activities and quality system updates and submitting clinical trial process revisions to the FDA
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The revised clinical trial process will revise the algorithm for diagnosing CDI recurrence and the planned statistical analysis
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▲ Dr.
Mark Smith, CEO of Finch Therapeutics "We are pleased that the FDA has completed its review of the information we provided and released the clinical trial of CP101
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" Dr.
Mark Smith, CEO of Finch said, "We look forward to completing the PRISM4 patient enrollment so that we can continue required activity, and we thank our PRISM4 clinical trial partners for their continued support
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"Reference: [1] Finch Therapeutics Announces Removal of FDA Clinical Hold on CP101 IND.
Retrieved April 29, 2022, from https://ir.
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.