SOMERVILLE, Mass.–(BUSINESS WIRE)–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.

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.

“With an estimated 1 in 59 children diagnosed with ASD and no
FDA-approved medications indicated for the core symptoms of ASD, there
is clearly a strong need to provide children and families impacted by
ASD with an effective therapy,” said Mark Smith, CEO of Finch. “We are
very encouraged by the preliminary clinical data in this field and look
forward to conducting the randomized, controlled clinical trials
necessary to fully assess the safety and efficacy of Full-Spectrum
Microbiota therapy for the treatment of children with ASD.”

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. Finch’s FSM therapy is also being evaluated in PRISM3,
an actively enrolling Phase II study in patients with recurrent C.
difficile infections (NCT03110133).

Full-Spectrum Microbiota therapy is not approved in any country. The FDA’s
Fast Track designation does not constitute or guarantee a future
approval and does not alter the standards for approval.

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.

Contacts

Gabriella Linville-Engler
[email protected]