On June 13, FDA reported that an immunocompromised patient treated with FMT died from a drug resistant infection. Importantly, this patient was not treated by Finch or our collaborator, OpenBiome. The FDA has communicated new mandatory screening standards, which Finch already exceeds. As a result, there is no impact on Finch’s work and our PRISM 3 and PRISM-EXT studies continue uninterrupted.
The infection occurred in a high-risk patient that received material from a donor that was not screened for a common drug resistant pathogen, resulting in exposure and subsequent infection. Finch has a thorough screening program which incorporates a panel of 30+ laboratory tests, including the agent associated with this adverse event, as part of our commitment to patient safety.
About Finch Therapeutics Group, Inc.
Finch Therapeutics Group, Inc. (Finch) is developing novel microbial therapies to serve patients with serious unmet medical needs. Built on 30 years of translational research at OpenBiome, MIT, University of Minnesota and the Center for Digestive Diseases, Finch uses Human-First Discovery™ to develop therapies from microbes that have demonstrated clinically significant impacts on patient outcomes. Finch is unique in having both a donor-derived Full-Spectrum Microbiota® (FSM®) product platform and a Rationally-Selected Microbiota® (RSM™) product platform based on microbes grown in pure culture. Finch’s lead program, CP101, is an investigational FSM product for prevention of recurrent C. difficile infections. Finch’s RSM platform employs machine-learning algorithms to mine Finch’s unique clinical datasets, reverse engineering successful clinical experience to identify the key microbes driving patient outcomes. Finch has a strategic partnership with Takeda to develop FIN-524, an investigational RSM product for inflammatory bowel disease. Finch is also developing an FSM product for the treatment of children with Autism Spectrum Disorder and associated GI symptoms. Finch is using a rich foundation of clinical data to advance its pipeline, leveraging proof-of-principle results to evaluate target indications and inform the design of this new therapeutic class.
Full-Spectrum Microbiota, FSM, Rationally-Selected Microbiota, RSM, and Human-First Discovery are trademarks of Finch Therapeutics Group, Inc.