First Wave BioPharma Inc - FWBI STOCK NEWS

First Wave BioPharma, Inc. (NASDAQ: FWBI) anticipates multiple clinical and development milestones in 2024, including the initiation of a Phase 3 clinical trial investigating latiglutenase in celiac disease. The potential business combination with ImmunogenX could provide access to Phase 3-ready latiglutenase, a potential first-in-class, targeted, oral biotherapeutic for celiac disease. Latiglutenase has been reviewed by the GI Division of the U.S. FDA, with Phase 3 trials expected to begin in the second half of 2024. The company also plans to announce a significant non-dilutive financial investment from a strategic global pharmaceutical company for commercial rights to latiglutenase in the U.S. and Canada, as well as financing commitments from institutional investors to fund the drug’s development. In addition, the company has added capeserod, a selective 5-HT4 receptor partial agonist, to its pipeline and is moving rapidly to initiate Phase 2 clinical trials in 2024. The company has also signed a non-binding term sheet to sell its niclosamide inflammatory bowel disease (IBD) program to an undisclosed biopharmaceutical company. The potential transaction with ImmunogenX, if completed, will allow First Wave BioPharma to focus on late-stage development programs, including latiglutenase and capeserod.