Finch Therapeutics Further Strengthens Patent Portfolio with Two New U.S. Patents Granted for FIN-211, an Investigational Microbiome Therapeutic in Development for Autism Spectrum Disorder
January 06 2022 - 7:00AM
Finch Therapeutics Group, Inc. (“Finch” or “Finch Therapeutics”)
(Nasdaq: FNCH), a clinical-stage microbiome therapeutics company
leveraging its Human-First Discovery® platform to develop a novel
class of orally administered biological drugs, today announced that
the U.S. Patent and Trademark Office has issued two new patents
covering the company’s FIN-211 enriched consortia microbiome
product candidate in development for children with autism spectrum
disorder (ASD) and significant gastrointestinal (GI) symptoms. The
company’s intellectual property portfolio now includes 59 issued
U.S. and foreign patents with more than 130 patent applications
pending.
The first patent (U.S. Patent No. 11,202,808) covers key
technologies involved in addressing ASD and GI symptoms associated
with ASD by orally administering a donor-derived microbial
community enriched with bacterial isolates from a genus with
potential therapeutic applications in ASD. This patent is jointly
owned with, and exclusively licensed from, the Arizona Board of
Regents on behalf of Arizona State University and the Regents of
the University of Minnesota. The second patent (U.S. Patent No.
11,207,356), solely owned by Finch, covers encapsulated
compositions containing donor-derived microbiota enriched with one
or more cultured bacterial strains, and methods of manufacturing
such compositions. The first and second patents have expiration
dates in 2036 and 2031, respectively.
“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 Mark Smith, PhD, Chief
Executive Officer of Finch Therapeutics. “We believe FIN-211 has
the potential to promote the broad functions of a diverse gut
microbiome while also targeting specific mechanisms that may be
important in ASD. We look forward to initiating our Phase 1b trial
of FIN-211 in children with ASD and constipation in the first half
of 2022, research that we believe will add to the growing body of
evidence supporting the potential for a microbiome-based
therapeutic option for children with ASD and significant GI
symptoms.”
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 CDC estimates that approximately one in 44 children in the
U.S. have been identified with ASD.3 ASD can cause challenges in
social interaction, communication, and behavior. A subset of
individuals with ASD experience significant GI symptoms, such as
constipation.4 There are no FDA-approved therapeutics for the core
symptoms of ASD and there is a significant unmet need for
treatments that effectively address the GI symptoms that some
children with ASD experience.
About Finch Therapeutics
Finch Therapeutics is a clinical-stage microbiome
therapeutics company leveraging its Human-First
Discovery® platform to develop a novel class of orally
administered biological drugs. With the capabilities to develop
both complete and targeted microbiome therapeutics, Finch is
advancing a rich pipeline of candidates designed to address a wide
range of unmet medical needs. Finch’s lead candidate, CP101, is in
late-stage clinical development for the prevention of
recurrent C. difficile infection (CDI), and has received
Breakthrough Therapy and Fast Track designations from the U.S. Food
and Drug Administration. In June 2020, Finch announced that CP101
met its primary efficacy endpoint in PRISM3, the first of two
pivotal trials to support the development of CP101 for the
prevention of recurrent CDI. PRISM4, a Phase 3 trial, is designed
to serve as the second pivotal trial of CP101 for recurrent CDI.
Finch is also developing CP101 for the treatment of chronic
hepatitis B virus, and FIN-211 for children with autism spectrum
disorder and significant gastrointestinal symptoms. Finch has a
partnership with Takeda focused on the development of targeted
microbiome therapeutics for inflammatory bowel disease.
Human-First Discovery® is a registered trademark of Finch
Therapeutics Group, Inc.
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 Securities and Exchange Commission
(“SEC”), including the section titled “Risk Factors” in Finch’s
Quarterly Report on Form 10-Q filed with the SEC on November 10,
2021, as well as discussions of potential risks, uncertainties, and
other important factors in Finch’s other filings with the SEC. All
forward-looking statements contained in this press release speak
only as of the date on which they were made. Except to the extent
required by law, Finch undertakes no obligation to update such
statements to reflect events that occur or circumstances that exist
after the date on which they were made.
- 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:
Stephen JasperGilmartin Group(858)
525-2047stephen@gilmartinir.com
Media Contact:
Jenna UrbanBerry & Company Public Relations(212)
253-8881jurban@berrypr.com
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