full spectrum microbiota (CP101) / Finch Therap - LARVOL DELTA

CP101 for the Treatment of Ulcerative Colitis (clinicaltrials.gov) - P1 | N=30 | Active, not recruiting | Sponsor: Brigham and Women's Hospital | Trial completion date: Jun 2025 ➔ Dec 2025

Trial completion date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

EVALUATING THE SAFETY AND TOLERABILITY OF CP101, AN ORAL MICROBIOME DRUG, IN MILD TO MODERATE UC: A DOSE FINDING PILOT STUDY. (DDW 2025) - "This trial provides supporting evidence of the potential benefit of microbiome therapeutics in mild-to-moderate UC. Despite the small sample size, the early efficacy signal suggests that larger studies are needed."

Clinical • Gastroenterology • Gastrointestinal Disorder • Inflammatory Bowel Disease • Ulcerative Colitis

CP101 for the Treatment of Ulcerative Colitis (clinicaltrials.gov) - P1 | N=30 | Active, not recruiting | Sponsor: Brigham and Women's Hospital | Recruiting ➔ Active, not recruiting

Enrollment closed • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Safety and Tolerability of CP101, a full spectrum, oral microbiome therapeutic for the prevention of recurrent C. difficile infection: A Phase 2 Randomized Controlled Trial. (PubMed, Gastroenterology) - P2 | "CP101 was superior to placebo in reducing recurrent CDI with a safety profile similar to placebo. https://clinicaltrials.gov/study/NCT03110133."

Journal • P2 data • Gastrointestinal Disorder • Infectious Disease • Transplantation

CP101 for the Treatment of Ulcerative Colitis (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Brigham and Women's Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

CP101 for the Treatment of Ulcerative Colitis (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: Brigham and Women's Hospital | Trial primary completion date: Apr 2025 ➔ Dec 2024

Trial primary completion date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

CP101 for the Treatment of Ulcerative Colitis (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: Brigham and Women's Hospital | Initiation date: Jun 2023 ➔ Sep 2023

Trial initiation date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

CP101 for the Treatment of Ulcerative Colitis (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: Brigham and Women's Hospital

New P1 trial • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Finch Therapeutics Reports First Quarter 2023 Financial Results and Provides Business Updates (GlobeNewswire) - "Research and development expenses were $8.6 million for the first quarter of 2023, compared to $15.5 million for the same period in 2022. The decrease was primarily due to a reduction in platform-related costs, in addition to reductions in the Company’s autism spectrum disorder, inflammatory bowel diseases, and hepatitis B programs. This was partially offset by increases in unallocated costs due to a change in allocation of personnel related expenses, and an increase in expenses related to our CP101 program, as the program and Phase 3 clinical trial were incurring expenses through the January 2023 discontinuation announcement."

Commercial • Hepatitis B • Immunology • Infectious Disease • Inflammatory Bowel Disease • Ulcerative Colitis

Finch Therapeutics Announces Clinical Collaboration in Ulcerative Colitis with Brigham and Women’s Hospital and Updates to University of Minnesota License Agreement (GlobeNewswire) - "Finch Therapeutics Group, Inc...announced that it has entered into a clinical trial agreement with Brigham and Women’s Hospital for the evaluation of CP101, a Complete Consortia microbiome therapeutic, in ulcerative colitis. The Company also announced updates to its license agreement with the University of Minnesota. Under the clinical trial agreement, Brigham and Women’s Hospital will conduct an investigator-sponsored trial that is designed to compare two doses of CP101 in patients with mild-to-moderate ulcerative colitis....Topline data from this clinical study is anticipated in 2025."

Clinical data • Licensing / partnership • Inflammatory Bowel Disease • Ulcerative Colitis

A Trial of CP101 for the Prevention of Recurrent CDI (PRISM4) (clinicaltrials.gov) - P3 | N=19 | Terminated | Sponsor: Finch Research and Development LLC. | Trial completion date: Oct 2024 ➔ Feb 2023 | Active, not recruiting ➔ Terminated | Trial primary completion date: Jan 2024 ➔ Feb 2023; The termination of FIN-CDI-301 (PRISM4) is based on the voluntary, business-related decision of the sponsor.

Trial completion date • Trial primary completion date • Trial termination • Infectious Disease

A Trial of CP101 for the Prevention of Recurrent CDI (PRISM4) (clinicaltrials.gov) - P3 | N=19 | Active, not recruiting | Sponsor: Finch Research and Development LLC. | Recruiting ➔ Active, not recruiting | N=324 ➔ 19

Enrollment change • Enrollment closed • Infectious Disease

A Trial of CP101 for the Prevention of Recurrent CDI (PRISM4) (clinicaltrials.gov) - P3 | N=324 | Recruiting | Sponsor: Finch Research and Development LLC. | Trial completion date: Dec 2023 ➔ Oct 2024 | Trial primary completion date: Feb 2023 ➔ Jan 2024

Trial completion date • Trial primary completion date • Infectious Disease

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 (ACG 2022) - "Among the 132 PRISM-EXT participants, the proportion without CDI recurrence following administration of SOC antibiotics and CP101 was 80.3% through Week 8 and 78.8% through Week 24. No treatment-related serious adverse events were reported. Microbiome analysis showed that diversity significantly increased from baseline through Week 8 (p< 0.0001) and Week 24 (p< 0.0001, Fig 1A)."

Clinical • Infectious Disease

A Trial of CP101 for the Prevention of Recurrent CDI (PRISM4) (clinicaltrials.gov) - P3 | N=324 | Recruiting | Sponsor: Finch Research and Development LLC. | Active, not recruiting ➔ Recruiting

Enrollment open • Infectious Disease

PRISM-EXT: Open-Label Extension of CP101 Trials Evaluating Oral Full-Spectrum Microbiota™ (CP101) in Subjects With Recurrence of Clostridium Difficile Infection (clinicaltrials.gov) - P2 | N=132 | Completed | Sponsor: Finch Research and Development LLC. | Active, not recruiting ➔ Completed | N=70 ➔ 132

Enrollment change • Trial completion • Infectious Disease • Transplantation

CP101, AN INVESTIGATIONAL MICROBIOME THERAPEUTIC FOR THE PREVENTION OF RECURRENT C. DIFFICILE INFECTION: A COMBINED ANALYSIS OF THE PRISM3 (RANDOMIZED PLACEBO-CONTROLLED) AND PRISM-EXT (OPEN-LABEL) TRIALS (DDW 2022) - "In this post-hoc analysis, the cumulative sustained clinical cure rate of CP101 changed from 74.5% in PRISM3 to 85.0% across both studies through Week 8. Notably, among participants that received CP101 in PRISM3, inclusive of those that rolled over to PRISM-EXT and received a second dose, the cumulative cure rate assessed in this post-hoc analysis was 88.2%."

Clinical • Infectious Disease

CP101, AN INVESTIGATIONAL ORALLY ADMINISTERED MICROBIOME THERAPEUTIC, WAS EFFECTIVE FOR PREVENTION OF RECURRENT C. DIFFICILE INFECTION: RESULTS FROM OPEN-LABEL PRISM-EXT TRIAL (DDW 2022) - "Conclusion In PRISM-EXT, CP101 prevented recurrence of CDI through Week 8 which was sustained through Week 24 with no treatment-related serious adverse events, consistent with previously reported data from the randomized, placebo-controlled PRISM3 trial. The PRISM-EXT Results also suggest that a second dose of CP101 successfully rescued a significant proportion of participants who did not respond to an initial dose of CP101."

Clinical • Infectious Disease

A Trial of CP101 for the Prevention of Recurrent CDI (PRISM4) (clinicaltrials.gov) - P3 | N=324 | Active, not recruiting | Sponsor: Finch Research and Development LLC. | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease

A Race to the Top for The New C Difficile Treatment Class (HCPLive) - "At least 3 companies have presented later phase data on live microbiota therapies for treating recurrent C difficile infections in 2021....But unlike the emergence of the new treatment class for IBD, Allegretti, who is leading the research for CP101, said the 3 treatments in development all have similar mechanisms of action and safety profiles, which was not really true for biologics."

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A Trial of CP101 for the Prevention of Recurrent CDI (PRISM4) (clinicaltrials.gov) - P3; N=324; Recruiting; Sponsor: Finch Research and Development LLC.

Clinical • New P3 trial • Infectious Disease • PCR

ACG 2021: Investigational Oral Microbiome Therapeutic Agent CP101 Effectively Treats Recurrent Clostridioides difficile (PracticeUpdate) - "'C. difficile infection, one of the most common healthcare-associated infections, is a debilitating and sometimes life-threatening disease that is characterized by severe diarrhea,' said coauthor Jessica R. Allegretti, MD...CP101 is an investigational, orally administered, complete microbiome therapeutic designed to enable prevention of recurrent C. difficile infection by restoring a diverse microbial community and key physiological pathways, which contributes to colonization resistance.'"

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Finch Therapeutics Reports Third Quarter 2021 Financial Results and Provides Business Updates (GlobeNewswire) - "Key Anticipated Milestones...Initiation of RECLAIM Phase 1b trial of CP101 in chronic HBV infection anticipated in early 2022, with topline data from an initial cohort expected in the second half of 2022."

New P1 trial • P1 data • Hepatitis B • Infectious Disease

Jessica R Allegretti, MD, MPH: Preventing Recurrent C Difficile with CP101 (HCPLive) - "Jessica R Allegretti, MD...presented her PRISM3 study at the American College of Gastroenterology 2021 conference....'It's extremely important in today's age to develop new safe microbiome therapeutics for C diff,' Allegretti said."

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Investigational therapeutic restores microbiome diversity in recurrent C. difficile (Healio) - "'Recurrent C. difficile infection is common following standard of care antibiotics and remains a significant burden on the health care system. Treatment guidelines recommend standard of care antibiotics; however, these therapies lead to significant microbiome disruptions which impairs colonization resistance,' Jessica R. Allegretti, MD, MPH...said during her presentation at the ACG Annual Scientific Meeting. 'Therefore, we desperately need new therapeutics to enhance microbiome recovery, measured by the increase in microbiome diversity, and enhance colonization resistance.'"

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