First Wave BioPharma Announces Exclusive Global License Agreement for Capeserod from Sanofi
14 Setembro 2023 - 7:00AM
First Wave BioPharma, Inc., (NASDAQ:FWBI), (“First Wave” or the
“Company”), a clinical-stage biopharmaceutical company specializing
in the development of targeted, non-systemic therapies for
gastrointestinal (GI) diseases, today announced an agreement with
Sanofi (NASDAQ: SNY) to license Capeserod, a selective 5-HT4
receptor partial agonist, which First Wave will repurpose and
develop for gastrointestinal (GI) indications.
Under the terms of the agreement, First Wave
will receive from Sanofi an exclusive, global license for Capeserod
and will assume responsibility for all future clinical development.
The licensing agreement, which includes a modest upfront payment,
backend milestone payments and single digit royalties on net sales,
provides a right of first refusal for Sanofi to reacquire Capeserod
following certain stages of clinical development and to
commercialize the product.
Sanofi’s research on Capeserod and the
subsequent artificial intelligence (AI)-empowered analyses suggest
that the drug’s mechanism of action has potential applications for
several gastrointestinal disorders in multibillion-dollar markets
where there are significant unmet clinical needs. Sanofi previously
conducted seven Phase 1 and two Phase 2 trials investigating the
potential of Capeserod for neurological disorders. In these trials,
involving over 600 patients, Capeserod appeared safe and
well-tolerated. First Wave will immediately request a meeting with
the U.S. Food and Drug Administration (FDA) to establish a
development and regulatory pathway for Capeserod in GI diseases
with the intent to initiate clinical trials in 2024.
“Securing an exclusive, worldwide license from
Sanofi for Capeserod is potentially a transformative event for
First Wave that adds a drug with a well-documented safety profile
to our GI-focused development pipeline,” stated James Sapirstein,
President and CEO of First Wave. “Capeserod has been investigated
in multiple clinical trials involving over 600 patients and through
this research and AI-based analyses evidence emerged suggesting the
drug possesses a unique mechanism of action that is applicable to
several GI indications underserved by currently available
therapeutics. We intend to immediately initiate discussions with
the FDA focused on a development and regulatory plan that would
enable us to begin Phase 2 clinical trials of Capeserod in
2024.”
Mr. Sapirstein continued: “First Wave is excited
by the opportunity to advance the development of Capeserod in this
new indication, and we are supportive of Sanofi’s outlook on AI and
its potential to expand the druggable universe, expedite the drug
screening process to find disease drivers and potential drug
candidates, and lower R&D expenses.”
About First Wave BioPharma,
Inc.First Wave BioPharma is a clinical-stage
biopharmaceutical company specializing in the development of
targeted, non-systemic therapies for gastrointestinal (GI)
diseases. The Company is currently advancing a therapeutic
development pipeline with multiple Phase 2 clinical stage programs
built around three proprietary technologies – Capeserod, a
selective 5-HT4 receptor partial agonist which First Wave will
pursue for gastrointestinal (GI) indications; the biologic
adrulipase, a recombinant lipase enzyme designed to enable the
digestion of fats and other nutrients in cystic fibrosis and
chronic pancreatitis patients with exocrine pancreatic
insufficiency; and niclosamide, an oral small molecule with
anti-inflammatory properties for patients with inflammatory bowel
diseases such as ulcerative colitis and Crohn’s disease. First Wave
BioPharma is headquartered in Boca Raton, Florida. For more
information visit www.firstwavebio.com.
Forward-Looking StatementThis
press release may contain certain statements relating to future
results which are forward-looking statements. It is possible that
the Company’s actual results and financial condition may differ,
possibly materially, from the anticipated results and financial
condition indicated in these forward-looking statements, depending
on factors including whether results obtained in preclinical and
nonclinical studies and clinical trials will be indicative of
results obtained in future clinical trials; whether preliminary or
interim results from a clinical trial will be indicative of the
final results of the trial; whether the Company will be able to
maintain compliance with Nasdaq’s continued listing criteria and
the effect of a delisting from Nasdaq on the market for the
Company’s securities; the size of the potential markets for the
Company’s drug candidates and its ability to service those markets;
the effects of the First Wave Bio, Inc. acquisition, the related
settlement and their effect on the Company’s business, operating
results and financial prospects; and the Company’s current and
future capital requirements and its ability to raise additional
funds to satisfy its capital needs. Additional information
concerning the Company and its business, including a discussion of
factors that could materially affect the Company’s financial
results are contained in the Company’s Annual Report on Form 10-K
for the year ended December 31, 2022 under the heading “Risk
Factors,” as well as the Company’s subsequent filings with the
Securities and Exchange Commission. All forward-looking statements
included in this press release are made only as of the date of this
press release, and we do not undertake any obligation to publicly
update or correct any forward-looking statements to reflect events
or circumstances that subsequently occur or of which we hereafter
become aware.
For more information:First Wave BioPharma,
Inc.777 Yamato Road, Suite 502Boca Raton, FL 33431Phone: (561)
589-7020info@firstwavebio.com
Media contact:Tiberend Strategic Advisors,
Inc.David Schemelia(609) 468-9325dschemelia@tiberend.com
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