FWBI First Wave BioPharma Inc

First Wave BioPharma, Inc., (NASDAQ: FWBI), (“First Wave BioPharma” or the “Company”), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today announced research generated from two previously completed Phase 2 clinical trials of latiglutenase has been published in the special issue "Recent Advances in Gluten-Free Diet and Celiac Disease" in the peer-reviewed scientific journal, Nutrients. Latiglutenase, an oral biotherapeutic composed of two gluten-specific recombinant proteases, is a potentially first-in-class, targeted, oral biotherapeutic for celiac disease (CeD).

The featured paper is entitled “Dynamics of Serologic Change to Gluten in Celiac Disease Patients” (doi.org/10.3390/nu15245083). The manuscript benefits from one of the largest databases of CeD clinical results from several Phase 2 clinical trials for latiglutenase and addresses two issues: (i) the return to seropositivity for CeD patients who resume a gluten containing diet for diagnostic purposes and (ii) the correlation between two different tTG-IgA assays at their defined upper limit of normal (ULN) thresholds.

“Our focus on developing latiglutenase is bolstered by this groundbreaking CeD research, just one component of the scientific, clinical, and regulatory expertise in gastroenterological drug development that Jack Syage and his team, formerly from ImmunogenX, bring to First Wave,” stated James Sapirstein, Chairman and CEO of First Wave. “The potential for latiglutenase to transform treatment is backed by solid data from these Phase 2 trials, which have shown latiglutenase to be safe, well-tolerated, and effective at breaking down the gluten proteins that lead to intestinal damage and the symptoms of celiac disease.”

“The research published in Nutrients highlights new tools that may serve as critical diagnostics for identifying seroactive patients and for monitoring the efficacy of latiglutenase,” stated Jack Syage, Ph.D. President & Chief Scientific Officer, First Wave BioPharma. “The evidence produced from this rich deposit of clinical data advances not only the development of latiglutenase but also benefits the whole field of celiac disease research in order to bring needed relief to the millions who suffer from this disease.”

About Latiglutenase Latiglutenase is an orally administered mixture of two minimally systemically absorbed gluten-specific recombinant proteases being developed as an oral biotherapeutic for celiac disease. In Phase 2a and 2b clinical trials, latiglutenase was shown to reduce the severity and frequency of symptoms as well as mitigate gluten-induced intestinal mucosal injury in celiac disease patients. The Phase 3 clinical development plan for latiglutenase has been reviewed by the GI Division of the U.S. Food and Drug Administration (FDA) at the End of Phase 2 meeting with an agreed plan forward, with initiation of the Phase 3 trials expected in early 2025. 

About Celiac Disease Celiac disease is a chronic, hereditary autoimmune and inflammatory disease triggered by gluten consumption. Celiac disease is characterized by damage to the lining of the small intestine, causing malabsorption, gastrointestinal dysfunction, and debilitating symptoms. Over the course of a lifetime, untreated or poorly managed celiac disease is often associated with deteriorating general health, multiple serious intestinal and extra-intestinal medical complications, and increased morbidity and mortality. Celiac disease is a global disease and affects approximately 1% of the population worldwide and is increasing in prevalence with improved diagnostic tools and improved awareness.  

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 late-stage clinical programs built around three proprietary technologies: latiglutenase, a Phase 3-ready, potentially first-in-class, targeted, oral biotherapeutic for celiac disease; capeserod, a selective 5-HT4 receptor partial agonist being developed for gastroparesis; and 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. First Wave BioPharma is headquartered in Boca Raton, Florida. For more information visit www.firstwavebio.com. 

Forward-Looking Statements This 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 any financing or licensing transaction may be completed, completed with different terms, in an untimely manner, or not at all; whether the Company will be able to realize the expected benefits of its acquisition of ImmunogenX; the Company’s ability to integrate the assets and contemplated commercial operations acquired from ImmunogenX into the Company’s business; 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 502 Boca Raton, FL 33431 Phone: (561) 589-7020 info@firstwavebio.com 

Media contact: Tiberend Strategic Advisors, Inc. David Schemelia (609) 468-9325 dschemelia@tiberend.com