Research & Development
Finch Therapeutics' CP101 receives US FDA breakthrough therapy designation
12 February 2019 -

Finch Therapeutics Group, a clinical-stage microbiome therapeutics company, has received breakthrough therapy designation from the US Food and Drug Administration (FDA) for its investigational drug, CP101, intended to treat patients with recurrent Clostridium difficile (C.difficile) infection, it was reported yesterday.

The company has designed CP101 therapeutic candidate for the prevention of recurrent C. difficile, which is a bacterial infection affecting more than 500,000 patients per annum.

The firm is recruiting patients with recurrent C. difficile in its PRISM3 randomised and placebo-controlled phase II clinical study to assess 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 investigational therapeutics for serious or life-threatening conditions.

The product 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 experience in providing microbial treatments to patients suffering from C. difficile.

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