BOCA RATON, Fla., Dec. 18, 2023 (GLOBE NEWSWIRE) -- 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 that the company has signed a non-binding term sheet for a business combination with ImmunogenX, a clinical-stage biotherapeutics company developing Phase 3-ready latiglutenase, a potentially first-in-class, targeted, oral biotherapeutic for celiac disease. Pursuant to the term sheet, First Wave BioPharma will acquire ImmunogenX in an all-stock transaction with the combined company focused on advancing a GI pipeline comprised of multiple late-stage clinical assets, including latiglutenase and capeserod, which First Wave BioPharma recently in-licensed from Sanofi. Following consummation of the transaction, First Wave BioPharma will continue to trade on Nasdaq under the ticker symbol “FWBI”. The transaction, which has been approved by the Boards of Directors of both companies, is subject to the negotiation and execution of definitive documentation, approval of the stockholders of both First Wave BioPharma and ImmunogenX and other customary closing conditions and is expected to close in the first half of 2024.

Following the closing, James Sapirstein will continue to serve as Chairman and Chief Executive Officer of First Wave BioPharma with Jack Syage, Ph.D., Chief Executive Officer and Co-Founder of ImmunogenX, assuming the role of President and Chief Operating Officer. Operational and financial leadership positions will be comprised of current First Wave BioPharma executives, while clinical, regulatory affairs, and scientific positions will be led by executives of ImmunogenX. First Wave BioPharma anticipates a significant non-dilutive financial investment from a strategic global pharmaceutical company for commercial rights to latiglutenase in the United States, in addition to financing commitments from several institutional investors to fund development, will be completed post-closing.

“A business combination with ImmunogenX will be a transformational event for First Wave as it will provide our company with a Phase 3-ready asset, latiglutenase, and scientific, medical, and regulatory experts from ImmunogenX, led by Dr. Jack Syage and by Professor Chaitan Khosla, who completed the seminal work leading to the discovery of latiglutenase at his laboratory at Stanford University,” stated Mr. Sapirstein. “Latiglutenase has the potential to be a first-to-market treatment for celiac disease, a GI-disorder that impacts approximately three million people in the U.S. and for which no approved pharmacologic treatment currently exists. Upon the closing of the business combination and concurrent financing and licensing transaction, we plan to immediately advance the regulatory, manufacturing, and clinical processes that would enable the initiation of the pivotal Phase 3 clinical trials of latiglutenase by the second half of 2024. This trajectory could enable latiglutenase to enter the multibillion-dollar celiac disease market by 2027.”

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 mitigate gluten-induced intestinal mucosal injury as well as reduce the severity and frequency of symptoms 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 the second half of 2024.

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.

“We are excited to align with First Wave BioPharma and join in the Company’s mission to be a leading developer of non-systemic therapeutics to treat GI diseases and bring relief to patients living daily with the often painful, dangerous, and discomforting symptoms inherent to such diseases, including celiac disease,” stated Dr. Syage. “Data from our Phase 2 program investigating latiglutenase suggest the drug is well-tolerated and can degrade key gluten proteins, which are known to cause gluten-induced intestinal mucosal injury and trigger the symptoms of celiac disease. This merger transaction with First Wave will bring vital backing to drive the latiglutenase program, for which we have garnered significant support from the NIH, including grant funding, and encouragement from the FDA.”

Tungsten Advisors is serving as the exclusive financial advisor to First Wave BioPharma.

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