The first patent (
“The granting of these two new patents further strengthens our growing patent portfolio and helps establish a firm foundation for the advancement of FIN-211, our first microbiome product candidate that leverages our ability to deliver a diverse microbial community that is enriched with key microbes,” said
About FIN-211 for Autism Spectrum Disorder (ASD)
FIN-211 is an investigational, orally administered microbiome therapeutic in development for children with ASD and significant gastrointestinal (GI) symptoms. FIN-211, an enriched consortia product candidate, is designed to deliver a diverse microbial community that is enriched with select bacteria grown in pure culture. FIN-211 is designed to address both the GI and core symptoms that can affect children with ASD.
Finch plans to initiate the Phase 1b AUSPIRE trial of FIN-211 in the first half of 2022, an open-label trial which is expected to enroll approximately 40 children with ASD and constipation. Multiple FIN-211 dosing regimens will be evaluated in the AUSPIRE trial, with safety and tolerability as the primary endpoints. Secondary endpoints include measures of pharmacokinetics, such as engraftment, and exploratory endpoints include assessments of behavioral scores and GI symptoms. The FIN-211 development program builds on multiple lines of evidence indicating a link between the microbiome and ASD, including several investigator-sponsored, proof-of-concept clinical (in-human) studies suggesting improvements in both GI and behavioral assessments following microbiota transplantation.1, 2
About Autism Spectrum Disorder (ASD)
The
About
Human-First Discovery® is a registered trademark of
Forward-Looking Statements:
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as “anticipates,” “believes,” “expects,” “intends,” “plans,” “potential,” "projects,” “would” and "future" or similar expressions are intended to identify forward-looking statements. These forward-looking statements include, but are not limited to, statements regarding: Finch’s ability to leverage its platform to develop a novel class of orally administered biological drugs; the therapeutic potential of FIN-211; and the timing, enrollment and results of Finch’s Phase 1b trial of FIN-211. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others: Finch’s limited operating history and historical losses; Finch’s ability to raise additional funding to complete the development and any commercialization of its product candidates; Finch’s dependence on the success of its lead product candidate, CP101; the possibility that Finch may be delayed in initiating, enrolling or completing any clinical trials; results of clinical trials may not be indicative of final or future results from later stage or larger clinical trials (or in broader patient populations once the product is approved for use by regulatory agencies) or may not be favorable or may not support further development; Finch’s product candidates may not generate the benefits to patients that are anticipated; anticipated regulatory approvals may be delayed or refused; competition from third parties that are developing products for similar uses; Finch’s ability to maintain patent and other intellectual property protection and the possibility that Finch’s intellectual property rights may be infringed, invalid or unenforceable or will be threatened by third parties; Finch’s ability to qualify and scale its manufacturing capabilities to support multiple global clinical trials; Finch’s lack of experience in selling, marketing and distributing its product candidates; Finch’s dependence on third parties in connection with manufacturing, clinical trials and preclinical studies; and risks relating to the impact and duration of the COVID-19 pandemic on Finch’s business. These and other risks are described more fully in Finch’s filings with the
Kang Sci Rep 2019 (https://pubmed.ncbi.nlm.nih.gov/30967657/)- Li Front Cell Infect Microbiol 2021 (https://pubmed.ncbi.nlm.nih.gov/34737978/)
- Maenner MMWR Surveillance Summaries 2021 (https://www.cdc.gov/mmwr/volumes/70/ss/ss7011a1.htm)
- Holingue Autism Res 2018 (https://pubmed.ncbi.nlm.nih.gov/28856868/)
Investor Contact:
(858) 525-2047
stephen@gilmartinir.com
Media Contact:
Berry & Company Public Relations
(212) 253-8881
jurban@berrypr.com
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