Autism Spectrum DIsorder
Finch is developing a Full-Spectrum Microbiota product for the treatment of children with Autism Spectrum Disorder (ASD).
Studies have shown that individuals with ASD commonly suffer from GI symptoms, such as constipation, diarrhea, and abdominal pain. Research characterizing the gut microbiome of individuals with ASD has revealed an abnormal gut microbiome compared to healthy controls. Previously, Adams and Krajmalnik-Brown, Finch’s collaborators at Arizona State University treated 18 children affected by ASD with Full-Spectrum Microbiota in an open-label study. They found the treatment was well-tolerated and led to a 77% reduction of GI symptoms and a 24% reduction of core ASD symptoms at eight weeks post-treatment. A recently published study that followed these 18 children for two years after initial treatment reports sustained improvements in GI symptoms and core behavioral ASD symptoms.
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the investigation of Full-Spectrum Microbiota as a treatment for children with 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 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 randomized, 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.