Finch Therapeutics Group has secured Breakthrough Therapy Designation in the US for its investigational drug CP101 for treating patients with recurrent Clostridium difficile (C. difficile) infection.
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 Centres 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 Finch CEO Mark Smith.
“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 said it 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.
CP101 is not currently approved in any country.