SOMERVILLE, Mass.--(BUSINESS WIRE)--Finch Therapeutics Group, Inc. (“Finch”), a clinical-stage microbiome therapeutics company, announced today that it has completed enrollment in PRISM3, its multi-center, placebo-controlled Phase 2 clinical trial evaluating CP101. CP101 is an oral, potentially first-in-class microbiome therapeutic that has been granted Fast Track and Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA), and is being investigated for the prevention of recurrent C. difficile infections (CDI).
A total of 206 participants were randomized in PRISM3 at 51 sites across the U.S. and Canada. Finch expects to report topline preliminary efficacy and safety results at the end of the second quarter of 2020. PRISM3 could serve as one of two pivotal trials required for product registration or, based on recent communication with the U.S. FDA, it may provide the data necessary to support registration without a second pivotal trial if a sufficient level of statistical significance is demonstrated in PRISM3.
“We are thrilled to have reached this important milestone on our journey to alleviate the suffering caused by recurrent CDI,” said Mark Smith, CEO of Finch. “We are excited to share the results of this landmark trial as we believe that positive PRISM3 results will not only impact the future treatment of recurrent CDI but will also validate the potential of microbiome therapeutics, paving the way for further development of potentially transformative therapies for a wide range of conditions linked to the microbiome.”
“We are deeply grateful to everyone that made it possible to reach the ambitious enrollment goals we set for the PRISM3 trial,” said Dr. Zain Kassam, CMO of Finch. “This achievement was enabled by each individual that participated in PRISM3 and the support of incredibly dedicated principal investigators and their clinical research staff. Alongside our collaborators, we will continue to work with urgency to develop an approved microbiome therapeutic for patients battling recurrent C. difficile infections.”
Finch plans to continue enrolling patients in an open-label safety study, PRISM-EXT, at sites participating in PRISM3. PRISM-EXT will allow eligible patients with recurrent CDI to have continued access to CP101 and will enable Finch to expand its safety database for CP101.
CP101 is an investigational Full-Spectrum Microbiota® (FSM®) therapy delivered in an oral capsule. Finch’s FSM therapies contain a diverse community of microbiota that are sourced from rigorously screened human donors and processed into capsules in accordance with Good Manufacturing Practice (GMP) standards. CP101 is designed to restore colonization resistance and prevent recurrence of C. difficile infection by delivering a diverse microbial community. CP101 has been awarded Fast Track and Breakthrough Therapy designation by the U.S. FDA. In August 2019, Finch raised $53 million in a Series C financing to advance CP101, its lead therapeutic candidate, and its pipeline of investigational therapies for other conditions linked to a disrupted gut microbiome.
About C. difficile Infection
Clostridioides difficile (C. difficile) is one of the top five most urgent antibiotic-resistant bacterial threats and the most common healthcare-associated infection according to the Centers for Disease Control. More than 450,000 individuals in the U.S. experience a CDI each year, with 20% of individuals suffering from recurrent CDI (i.e. more than one episode of CDI). CDI contributes to more than 29,000 deaths and drives more than $6 billion in healthcare costs per year in the U.S. alone.
Finch Therapeutics Group, Inc. (Finch) is developing novel microbiome therapeutics to serve patients with serious unmet medical needs. Built on 30 years of translational research at OpenBiome, MIT, University of Minnesota and the Center for Digestive Diseases, Finch uses Human-First Discovery® to develop therapies from microbes that have demonstrated a clinically significant impact on patient outcomes. Finch is unique in having both a donor-derived Full-Spectrum Microbiota® (FSM®) product platform and a Rationally-Selected Microbiota® (RSM®) product platform based on microbes grown in pure culture. Finch’s lead program, CP101, is an investigational FSM product with Fast Track and Breakthrough Therapy designation from the FDA for the prevention of recurrent C. difficile infection. Finch also has Fast Track designation from the FDA for a program to develop a microbiome therapeutic for children with Autism Spectrum Disorder.
Finch’s RSM platform employs machine-learning to mine Finch’s unique clinical datasets, reverse engineering successful clinical experience to identify the key microbes driving patient outcomes. Finch has a strategic partnership with Takeda Pharmaceuticals to develop FIN-524, an investigational RSM product for ulcerative colitis. Finch and Takeda are also utilizing Finch’s platform to target Crohn’s disease, another form of inflammatory bowel disease.
Finch is using a rich foundation of clinical data to advance its pipeline, leveraging proof-of-principle results to evaluate target indications and inform the design of this new therapeutic class.
CP101 is not approved in any country. The FDA's Fast Track and Breakthrough Therapy designations do not constitute or guarantee future approval or alter the standards for approval.
Full-Spectrum Microbiota, FSM, Rationally-Selected Microbiota, RSM, and Human-First Discovery are trademarks of Finch Therapeutics Group, Inc.