OpenBiome and Finch Therapeutics Group: working to ensure continued safe access to FMT.
Members of OpenBiome’s founding team launched Finch Therapeutics Group, a clinical-stage biopharmaceutical company, to help get a microbiome-based treatment approved by the FDA for the prevention of recurrent C. difficile — a lengthy, expensive process that OpenBiome could not undertake alone as a nonprofit. FMT is currently regulated as an investigational new drug, though it is available outside of trials though an interim FDA policy for C. difficile that is not responsive to standard therapy. FDA approval of a microbiome-based treatment, such as FMT, would help secure its availability in perpetuity, and remove barriers for many patients and facilities, including treatment delays and reimbursement challenges. OpenBiome and Finch also collaborate on other research projects to evaluate FMT in diseases beyond C. difficile.
OpenBiome collaborated with Finch to develop CP101, a freeze-dried oral FMT capsule, for treatment of recurrent C. difficile. Finch is running a clinical trial to test CP101, and trial sites around the U.S. and Canada are now enrolling patients. Learn more about participating in the trial at prism3trial.com.
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