First Wave BioPharma Chooses Pace® Life Sciences as CDMO Partner.
BOCA RATON, Fla., Sept. 07, 2022 (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, announced today the selection of an enhanced enteric microgranule drug delivery formulation for the ongoing development of its adrulipase clinical program (FW-EPI). First Wave BioPharma now plans to submit an Investigational New Drug (IND) amendment to the U.S. Food & Drug Administration (FDA) for a Phase 2 “proof-of-concept” clinical study investigating the optimized version of adrulipase as a treatment for exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis (CF) and chronic pancreatitis (CP). First Wave BioPharma expects to initiate the Phase 2 trial prior to year-end 2022 following acceptance of the IND.