First Wave BioPharma, Inc.
First Wave BioPharma, Inc. is a clinical-stage biopharmaceutical company developing 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 that 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.
The Company's lead product candidate is adrulipase. In January 2023, First Wave initiated a Phase 2b bridging study evaluating an improved enteric microgranule formulation of adrulipase in CF patients with EPI. While initial topline data from this study announced in July 2023 indicated the new formulation was safe and improved over prior versions, it likely did not meet the primary efficacy endpoint. Additional Phase 2b study data will be reported towards the end of 2023.
In September 2023, First Wave 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 (GI) indications such as pediatric ulcerative colitis (an orphan disease) and gastroparesis.
Headquartered in Boca Raton, Florida, First Wave continues working to advance its pipeline of non-systemic GI therapies. For more information, visit www.firstwavebio.com.