Finch Therapeutics Receives Fast Track Designation for the Investigation of Full-Spectrum Microbiota as a Treatment for Children with Autism Spectrum Disorder

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    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
    (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
    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

    “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
    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.
    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.
    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
    ™ 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 MicrobiotaFSMRationally-Selected
    RSM, and Human-First Discovery are
    trademarks of Finch Therapeutics Group, Inc.


    Gabriella Linville-Engler
    [email protected]