Finch Therapeutics Group has secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for its investigational drug CP101 to treat patients with recurrent Clostridium difficile (C. difficile) infection.
Finch has designed CP101 therapeutic candidate for the prevention of recurrent C. difficile, which is a bacterial infection affecting more than 500,000 patients per year.
The Centers for Disease Control (CDC) has named recurrent C. difficile as an urgent public health threat, as most of the patients failing to secure standard-of-care antibiotic treatment.
The firm is recruiting patients with recurrent C. difficile in PRISM3 randomized and placebo-controlled phase II clinical study to evaluate the safety and efficacy of CP101.
According to the company, the study drug is an oral capsule, which is administered in a single dose.
Breakthrough Therapy Designation is intended to enhance and review of investigational therapeutics for serious or life-threatening conditions.
Finch CEO Mark Smith said: “We are thrilled that CP101 has been designated as a Breakthrough Therapy for recurrent C. difficile.
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 Therapeutics is engaged in the development of novel microbial therapies for the treatment of patients with serious unmet medical needs.
Based on translational research from OpenBiome, MIT, University of Minnesota and the Center for Digestive Diseases, the company uses Human-First Discovery for the development of therapies from microbes that have showed clinically significant impacts on patient outcomes.
The firm’s RSM platform deploys machine-learning algorithms to study unique clinical data and identify crucial microbes that drive patient outcomes.
Finch has collaborated with Takeda for the development of FIN-524, which is an investigational RSM product for inflammatory bowel disease.