Finch Therapeutics (FNCH) Presents Positive Data from PRISM3 Clinical Trial of CP101 for Recurrent C. difficile at American College of Gastroenterology Annual Scientific Meeting

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 clinical data supporting CP101 for the prevention of recurrent C. difficile infection (CDI) at the American College of Gastroenterology (ACG) Annual Scientific Meeting being held October 22-27, 2021 in a hybrid format. Results from PRISM3, a Phase 2, randomized, placebo-controlled, multi-center clinical trial evaluating the investigational orally administered candidate CP101 for the prevention of recurrent CDI, including new 24-week safety and efficacy data, will be shared in two posters and an oral presentation at the meeting.

“We are excited to share these additional data supporting CP101, the first orally administered microbiome candidate to demonstrate durable efficacy and a favorable safety profile in a large randomized, placebo-controlled trial that included all stages of recurrent CDI and all guideline recommended methods of CDI diagnosis at trial entry. These are important features of the PRISM3 trial that we believe position CP101 to serve a broad patient population,” said Zain Kassam, MD, MPH, Chief Medical Officer at Finch Therapeutics. “We believe these robust PRISM3 data illustrate the potential for CP101 to serve as a convenient, first-line option for clinicians and patients fighting the devastating effects of recurrent CDI.”

Summary of PRISM3 posters presented at the ACG meeting:

Poster Title: “Week 24 Efficacy and Safety Data from PRISM3: A Randomized, Placebo-Controlled Trial Evaluating CP101, an Investigational Orally Administered Microbiome Therapeutic for Prevention of Recurrent C. difficile Infection” (P0130)

• CP101 demonstrated efficacy through week 24, with 73.5% of participants in the CP101 arm (n=102) experiencing a sustained clinical cure (defined as absence of CDI recurrence) through week 24 versus 59.4% in the placebo arm (n=96) (p=0.0347).
• CP101 exhibited a favorable safety profile through week 24, with similar rates of adverse events and drug-related treatment emergent adverse events in both the CP101 and placebo arm. No drug-related serious adverse events were reported in the CP101 arm through week 24.
• As previously reported, CP101 met its primary efficacy endpoint in PRISM3, with 74.5% of participants who received a single oral administration of CP101 following standard-of-care (SOC) antibiotics achieving a sustained clinical cure through week 8, versus 61.5% of participants who received placebo following SOC antibiotics (p=0.0488), representing a 33.8% relative risk reduction for CDI recurrence.

Poster Title: “CP101 Engraftment Drives Efficacy: Results from a Randomized, Placebo-Controlled Trial Evaluating CP101, an Investigational Orally Administered Microbiome Therapeutic for Prevention of Recurrent C. difficile Infection” (P0129)

• Treatment with CP101 in PRISM3 resulted in significant engraftment at week 1, with engraftment defined as the presence of CP101-specific microbes that colonized the gastrointestinal tract of participants.
• CP101 engraftment was associated with sustained clinical cure in PRISM3. Among PRISM3 participants with successful engraftment at week 1 following administration of CP101, 96.0% achieved a sustained clinical cure at week 8, while unsuccessful engraftment resulted in a 54.2% sustained clinical cure rate, similar to participants who were administered placebo following CDI antibiotics (p<0.001).
• Engraftment of CP101 microbes may have been impacted by the persistence of residual broad-spectrum vancomycin, despite participants completing a minimum two-day washout period to ensure antibiotic clearance from the colon. Data suggest that a two-day washout period may be insufficient to clear residual vancomycin. Future trials, including PRISM4, a Phase 3, placebo-controlled trial of CP101 for recurrent CDI, will deploy strategies to optimize engraftment by further minimizing the effect of residual broad-spectrum antibiotics.

In addition to the two poster presentations, Jessica R. Allegretti, MD, MPH, Associate Director, Crohn's and Colitis Center, Brigham and Women’s Hospital, Assistant Professor, Harvard Medical School, will give an oral presentation on Tuesday, October 26, 2021 at 9:30 am PT entitled “CP101, an Investigational Orally Administered Microbiome Therapeutic, Increases Intestinal Microbiome Diversity and Prevents Recurrent C. difficile Infection: Results From a Randomized, Placebo-Controlled Trial” (oral abstract #25). The abstract was awarded ACG’s prestigious Outstanding Research Award.

The presented data are available to registered attendees through the ACG Annual Scientific Meeting website and copies of the posters will be provided on the Finch website after the meeting.

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