Finch Therapeutics Group Inc (FNCH)

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Finch Therapeutics Presents PRISM-EXT Biomarker Data at ACG 2022 and Proceeds with Patient Dosing in Phase 3 Trial of CP101 in Recurrent C. Difficile Infection
October 24 2022 - 08:00AM
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Finch Therapeutics Group, Inc. (“Finch” or “Finch Therapeutics”) (Nasdaq: FNCH), a clinical-stage microbiome therapeutics company leveraging its Human-First Discovery® platform to develop a novel class of orally administered biological drugs, today announced the presentation of biomarker data from PRISM-EXT, a Phase 2 open-label trial of CP101 in recurrent C. difficile infection (CDI), at the American College of Gastroenterology (ACG) 2022 Annual Scientific Meeting, being held October 21-26, 2022 in Charlotte, NC. Finch also announced today that the company has proceeded with patient dosing in PRISM4, a Phase 3 trial of CP101 for the prevention of recurrent CDI.
“This is an exciting time for Finch and the overall microbiome field, with hope and new potential therapeutic options on the horizon for patients fighting recurrent CDI,” said Howard Franklin, MD, MBA, Chief Medical Officer of Finch Therapeutics. “At ACG’s annual meeting, we are pleased to be presenting biomarker data from our PRISM-EXT trial showing that higher engraftment of CP101 microbes and an increase in intestinal microbiome diversity were both associated with prevention of recurrent CDI. These results further our understanding of the pharmacokinetics and pharmacodynamics of CP101 and support our efforts to optimize engraftment of CP101 microbes.”

Dr. Franklin continued, “We are also very pleased to be back in the clinic with CP101 and are deeply grateful to our PRISM4 study sites and study participants for their dedication to supporting the development of CP101. We will continue to work with urgency to advance CP101, an investigational microbiome therapeutic that we believe holds the promise of fulfilling the need for a convenient, one-time oral therapy that can break the cycle of CDI recurrence.”

The PRISM-EXT poster details are as follows:

Poster Title: Evaluation of Engraftment and Diversity Following Open Label Administration of CP101, an Investigational Oral Microbiome Therapeutic for the Prevention of Recurrent C. Difficile Infection, in the PRISM-EXT Trial (E0096)
Presenting Author: Jessica R. Allegretti, MD, MPH, Brigham and Women's Hospital, Boston, MA and Harvard Medical School, Boston MA
Presentation Date and Time: Tuesday, October 25, 2022 at 3:00 pm ET

Following open-label administration of CP101 after standard-of-care (SOC) CDI antibiotics, there was a significant increase in microbiome diversity from baseline through week 8 and week 24 in PRISM-EXT participants.
Higher engraftment of CP101-associated taxa and improvement in diversity were both associated with prevention of CDI recurrence through week 8.
As previously reported, 80.3% and 78.8% of participants who received CP101 following SOC antibiotics in PRISM-EXT were without CDI recurrence through week 8 and week 24, respectively (n=132). The CP101 safety results from PRISM-EXT were consistent with previously reported results, with no treatment-related serious adverse events or deaths. The most frequent treatment-related adverse events were gastrointestinal symptoms of mild-moderate severity.
PRISM-EXT was a Phase 2, multi-center, open-label trial of CP101 for the prevention of recurrent CDI in adults with one or more CDI recurrences. The primary endpoints were safety and the proportion of participants without CDI recurrence through week 8. Participants were followed through week 24 for safety and CDI recurrence. Exploratory microbiome endpoints were measured at baseline following SOC antibiotics, week 8 and week 24 using 16S rRNA gene amplicon sequencing. A copy of the PRISM-EXT poster presented at ACG will be available on the ‘Publications’ page of the Finch website after the meeting.

About CP101

CP101 is an investigational microbiome therapeutic designed to deliver a diverse microbial community in a one-time oral administration, without the need for bowel preparation. CP101 is designed to enable prevention of recurrent C. difficile infection (CDI) by restoring a diverse microbial community and key physiological pathways that are believed to contribute to colonization resistance.

About the PRISM4 Phase 3 Trial

PRISM4 is a randomized, double-blind, placebo-controlled, multi-center Phase 3 trial evaluating the efficacy and safety of a one-time oral administration of CP101 for the prevention of recurrent C. difficile infection (CDI). After completing standard-of-care CDI antibiotics for their most recent CDI recurrence, eligible participants will be randomized in a 2:1 ratio to receive either CP101 or placebo. Participants will be evaluated for CDI recurrence and safety through week 8, the primary endpoint, as well as through week 24. Participants who qualify may enroll in the optional open label arm and receive CP101 if they experience a CDI recurrence through week 8 of the trial. To learn more about the trial, visit clinicaltrials.gov (Identifier: NCT05153499) or the study website at https://prism4trial.com/.