Policy & Regulation
Finch Therapeutics' Investigational Drug CP101 Granted Breakthrough Therapy Designation from FDA for Recurrent C. Difficile Infection
8 February 2019 - - The US Food and Drug Administration has granted Breakthrough Therapy Designation to investigational drug CP101 for the treatment of patients with recurrent Clostridium difficile (C. difficile) infection, US-based microbiome therapeutics company Finch Therapeutics Group, Inc said.

Breakthrough Therapy Designation is intended to expedite the development and review of investigational therapeutics for serious or life-threatening conditions where preliminary clinical evidence indicates that the product may demonstrate a substantial improvement over existing therapies on one or more clinically significant endpoints.

Finch's lead therapeutic candidate CP101 is designed to prevent recurrent C. difficile, a bacterial infection affecting over 500,000 patients each year and leading to an estimated 29,000 annual deaths.

Recurrent C. difficile has been named an urgent public health threat by the Centers for Disease Control and, with a high percentage of patients failing standard-of-care antibiotic treatment, presents a clear and urgent unmet medical need.

Finch is actively enrolling patients with recurrent C. difficile in PRISM3, a randomized, placebo-controlled Phase II clinical study to assess the safety and efficacy of CP101.

The study drug is an oral capsule that is administered in a single dose.

CP101 is not approved in any country. The FDA's Breakthrough Therapy Designation does not constitute or guarantee a future approval and does not alter the standards for approval.

Finch Therapeutics Group is developing novel microbial therapies 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 clinically significant impacts 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 programme, CP101, is an investigational FSM product for prevention of recurrent C. difficile infections. Finch's RSM platform employs machine-learning algorithms to mine Finch's unique clinical datasets, reverse engineering successful clinical experience to identify the key microbes driving patient outcomes.

The company has a strategic partnership with Takeda to develop FIN-524, an investigational RSM product for 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.

Full-Spectrum Microbiota, FSM, Rationally-Selected Microbiota, RSM, and Human-First Discovery are trademarks of Finch Therapeutics Group, Inc.