29 April 2019 - Finch Therapeutics announced today that the U.S. FDA has granted fast track designation to its full-spectrum microbiota therapy for the treatment of children with autism spectrum disorder.

Finch is supporting an actively enrolling Phase II investigator-initiated clinical study evaluating the safety and efficacy of its Full-Spectrum Microbiota therapy in adults with ASD (NCT03408886). Finch also plans to conduct a randomised, placebo-controlled, Phase II clinical study in children with ASD (NCT03829878). 

In both studies, the study drug is an oral capsule designed to contain a diverse community of microbiota capable of restoring an unbalanced microbiome. Finch’s FSM therapy is also being evaluated in PRISM3, an actively enrolling Phase II study in patients with recurrent C. difficile infections (NCT03110133).

Read Finch Therapeutics press release