Finch Therapeutics announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to CP101 for the treatment of patients with recurrent Clostridium difficile (C. difficile) infection. 

CP101 is an investigational oral full-spectrum microbiota (FSM) product being developed to prevent recurrent C. difficile infections. It contains various functional microorganisms which may engraft in the host microbiome and help restore gut flora. Moreover, CP101 capsules offer longer shelf-life due to a novel processing method and formulation that provides stability. 

Currently, a Phase 2 randomized, placebo-controlled study (PRISM3) is underway and actively enrolling ~200 patients with recurrent C. difficile. The study will compare the safety and efficacy of CP101 capsules vs placebo in adults aged 18 years and older who have been prescribed antibiotics for their most recent C. difficile episode. The primary outcome measures are the proportion of patients with no recurrence of symptomatic, laboratory confirmed C. difficile infection, as well as the proportion of patients with adverse events at Week 8.

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“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,” stated Mark Smith, CEO of Finch.

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