Full Press Release Details
First Wave BioPharma
Announces Exclusive Global License Agreement for Capeserod from Sanofi
First Wave to develop and repurpose Capeserod
for gastrointestinal (GI) indications based on AI-empowered analyses, expanding the company's GI-focused pipeline
BOCA RATON, Fla. September 14, 2023 -- 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
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 Statement
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
For more information:
First Wave BioPharma, Inc.
777 Yamato Road, Suite 502
Boca Raton, FL 33431
Phone: (561) 589-7020
Tiberend Strategic Advisors, Inc.