BOCA RATON, Fla. - First Wave BioPharma, Inc. (NASDAQ: FWBI), a clinical-stage biopharmaceutical company, announced the acquisition of ImmunogenX in an all-stock transaction, aiming to advance treatments for gastrointestinal diseases, including a promising therapy for celiac disease named latiglutenase. The deal positions latiglutenase, an oral biotherapeutic currently nearing Phase 3 clinical trials, as a potentially first-in-class treatment for celiac disease.
James Sapirstein will maintain his role as Chairman and CEO of First Wave BioPharma, while Jack Syage, Ph.D., co-founder and former CEO of ImmunogenX, steps in as President and COO. Both Dr. Syage and Dr. Chaitan Khosla will join First Wave BioPharma's board of directors.
The company plans to license the commercial rights for latiglutenase in the United States and Canada to a global pharmaceutical company and is seeking to secure financing from institutional healthcare investors. The strategic licensing agreement and financing are expected to be finalized in the second half of 2024, subject to customary conditions including due diligence, definitive agreements, Board approval, and necessary third-party approvals.
Latiglutenase has shown efficacy in Phase 2 trials, involving approximately 200 patients, in reducing intestinal damage and alleviating symptoms of celiac disease. The U.S. Food and Drug Administration (FDA) has reviewed the Phase 3 clinical plan for latiglutenase, with trials anticipated to begin in early 2025.
Celiac disease is a chronic autoimmune disorder where ingestion of gluten leads to damage in the small intestine. It affects about 1% of the global population. Currently, there is no approved pharmacologic treatment for celiac disease, presenting a significant market opportunity for latiglutenase.
In addition to latiglutenase, First Wave BioPharma's portfolio includes capeserod, a treatment for gastroparesis, and adrulipase, designed for patients with exocrine pancreatic insufficiency due to cystic fibrosis or chronic pancreatitis.
Upon closing the acquisition, First Wave BioPharma issued shares to ImmunogenX shareholders, representing an 81.9% stake in the combined entity on a fully diluted basis, with a combined equity value of $104 million. Tungsten Advisors served as the exclusive financial advisor to First Wave BioPharma.
This news is based on a press release statement from First Wave BioPharma.
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