Designation to accelerate Finch’s efforts to provide an effective
therapy for patients fighting recurrent C. difficile infection.
SOMERVILLE, Mass.–(BUSINESS WIRE)–Finch Therapeutics Group, Inc., a clinical-stage microbiome therapeutics
company, today announced that the U.S. Food and Drug Administration
(FDA) has granted Breakthrough Therapy Designation to investigational
drug CP101 for the treatment of patients with recurrent Clostridium
difficile (C. difficile) infection. 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 (CDC) and, with a high
percentage of patients failing standard-of-care antibiotic treatment,
presents a clear and urgent unmet medical need.
“We are thrilled that CP101 has been designated as a Breakthrough
Therapy for recurrent C. difficile,” said Mark Smith, CEO of
Finch. “CP101 is designed to break the cycles of infection by restoring
the balance of the gut microbiome, an approach supported by numerous
clinical studies and Finch’s extensive experience providing microbial
treatments to patients suffering from C. difficile. This
designation will accelerate our efforts to provide an effective therapy
for patients living with this devastating infection, and we look forward
to working closely with the FDA to advance that mission.”
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. For more information
about this trial, please visit www.prism3trial.com.
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.
About Finch Therapeutics Group, Inc.
Therapeutics Group, Inc. (Finch) 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
program, 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. Finch 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
Full-Spectrum Microbiota, FSM, Rationally-Selected
Microbiota, RSM, and Human-First Discovery are
trademarks of Finch Therapeutics Group, Inc.