Finch Therapeutics Announces Clinical Collaboration in Ulcerative Colitis with Brigham and Women’s Hospital and Updates to University of Minnesota License Agreement
18 Aprile 2023 - 10:01PM
Finch Therapeutics Group, Inc. (“Finch”, “Finch Therapeutics” or
the “Company”) (Nasdaq: FNCH), a microbiome technology company with
a portfolio of intellectual property and microbiome assets, today
announced that it has entered into a clinical trial agreement with
Brigham and Women’s Hospital for the evaluation of CP101, a
Complete Consortia microbiome therapeutic, in ulcerative colitis.
The Company also announced updates to its license agreement with
the University of Minnesota.
Under the clinical trial agreement, Brigham and Women’s Hospital
will conduct an investigator-sponsored trial that is designed to
compare two doses of CP101 in patients with mild-to-moderate
ulcerative colitis. The study is designed to generate data on
safety, pharmacokinetics, pharmacodynamics and clinical efficacy,
and aims to build on a growing body of evidence supporting the role
of the microbiome in improving outcomes for patients suffering from
ulcerative colitis. Topline data from this clinical study is
anticipated in 2025.
The Company also announced that it has amended its license
agreement with the University of Minnesota, through which Finch has
exclusively licensed 13 issued patents and 7 patent applications
covering specific approaches to formulations comprising human fecal
microbes, methods of increasing microbiota diversity, and methods
of decreasing the relative abundance of certain bacteria. A key
feature of the amendment allows Finch to satisfy certain
performance milestones through sublicensing agreements, aligning
with Finch’s new strategic focus on collaborations and
partnerships.
“Today’s announcements reflect our continued progress executing
against our strategy to build value and advance our microbiome
technology through external partnerships,” said Mark Smith, PhD,
Chief Executive Officer of Finch Therapeutics. “The clinical trial
agreement to evaluate CP101 in ulcerative colitis builds on many
years of work at Finch to develop product candidates to serve this
important unmet medical need. We look forward to working with our
collaborators at Brigham and Women’s Hospital to evaluate CP101 in
this new clinical setting, where I believe an orally administered
Complete Consortia product offers the potential to reset the
pathophysiology of this disease. I am also pleased to extend our
long-standing relationship with the University of Minnesota, which
we believe positions us to continue to advance our microbiome
technology through collaborations and partnerships.”
About CP101
CP101 is an investigational, orally administered microbiome
therapeutic designed to deliver a diverse microbial community.
CP101 is designed to address multiple therapeutic indications by
restoring a diverse microbial community and key physiological
pathways that are believed to be disrupted in multiple gut- and
immune-related diseases.
About Finch Therapeutics
Finch Therapeutics is a microbiome technology company with a
portfolio of intellectual property and microbiome assets. Finch has
a robust intellectual property estate reflecting the Company’s
pioneering role in the microbiome therapeutics field, including
more than 70 issued U.S. and foreign patents with critical
relevance for both donor-derived and donor-independent microbiome
therapeutics in a range of potential indications. Finch’s assets
include CP101, an investigational, orally administered microbiome
candidate with positive clinical date from a Phase 2 randomized,
placebo-controlled trial and a Phase 2 open-label trial in
recurrent C. difficile infection (CDI). Additionally, Finch has
pre-clinical assets that are designed to target ulcerative colitis,
Crohn’s disease, and autism spectrum disorder, along with a
significant biorepository of samples and microbial strains. In
January 2023, Finch announced a decision to discontinue its Phase 3
trial of CP101 in recurrent CDI. Following this decision, Finch is
focused on realizing the value of its intellectual property estate
and other assets, while supporting the advancement of its
microbiome technology through partnerships and collaborations.
Forward-Looking Statements:
This press release includes “forward-looking statements.” Words
such as “will,” "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: the outcome and timelines associated with the
investigator-sponsored trial to be conducted with Brigham and
Women’s Hospital and the ability of the investigator-sponsored
trial to contribute to the body of evidence supporting the role of
the microbiome in improving outcomes for patients suffering from
ulcerative colitis; Finch’s ability to execute against its strategy
to build value and advance its microbiome technology through
external innovation, including collaborations and partnerships; the
therapeutic potential of CP101 in ulcerative colitis; and the
ability of the Company to advance its microbiome technology through
collaborations and partnerships. 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,
those related to: the possibility that Finch will not be able to
realize the value of its intellectual property estate and other
assets; Finch’s ability to comply with regulatory requirements; the
possibility that Finch’s collaborators may be delayed in
initiating, enrolling or completing 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) or may not be favorable or may not support further
development; product candidates developed using Finch’s microbiome
technology may not generate the benefits to patients that are
anticipated; and 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. 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 Annual Report on Form 10-K for the
year ended December 31, 2022, filed with the SEC on March 23, 2023,
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.
Investor Contact: Stephen Jasper Gilmartin
Group (858) 525-2047 stephen@gilmartinir.com
Media and Collaborator Contact:
info@finchtherapeutics.com
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