The human microbiome is the community of bacteria and microorganisms that lives in association with the human body.
A Human-First Discovery approach accelerates our development of microbial therapeutics.
When Smith launched OpenBiome, the entire landscape of CDI treatment changed. Now that he is at Finch Therapeutics, Smith is ready to change the treatment landscapes of many more diseases. “If we could manage this ecosystem and intentionally modulate the composition of this community,” he declares, “we could radically impact the drivers of morbidity and mortality.”
‘Meanwhile, the success of the study in Arizona has prompted America’s Food and Drug Administration (FDA) to look into the matter. A firm called Finch Therapeutics Group, based in Massachusetts, hopes to commercialise the use of MTT as a treatment for autism and the FDA has now granted this effort “fast track” status, which should speed up the review process.’
“Over the past decade, tens of thousands of Americans with C. diff have been cured through fecal transplants, often with a single dose that can bring patients back from the brink of death. The treatment has more than an 80 percent success rate, according to several studies, and many patients feel better within hours of receiving the procedure, which is usually administered through colonoscopy or capsules containing desiccated fecal matter.”
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.
Finch Therapeutics Group, Inc., a clinical-stage microbiome therapeutics company, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its Full-Spectrum Microbiota® (FSM®) therapy for the treatment of children with Autism Spectrum Disorder (ASD). Fast Track designation is intended to facilitate development and expedite review of therapies designed to treat serious conditions and fill an unmet medical need.
Finch Therapeutics Group, Inc., a clinical-stage microbiome therapeutics company, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to investigational drug CP101 for the treatment of patients with recurrent Clostridium difficile (C. difficile) infection.
Finch Therapeutics Group, Inc. (Finch), a clinical-stage microbiome therapeutics company, announced today that the U.S. Patent and Trademark Office (USPTO) has issued six new patents to Finch covering its Full-Spectrum Microbiota (FSM) and Rationally-Selected Microbiota (RSM) product platforms.
Finch Therapeutics Group, Inc. (Finch), a clinical-stage microbiome therapeutics company, announced today that it has appointed Ulrich Thienel, Ph.D., M.D., as Chief Medical Officer and Gregory Perry as Chief Financial Officer.