First Wave BioPharma announces expansion of adrulipase IP portfolio

First Wave BioPharma announced the company has filed a U.S. Provisional Patent application involving composition of matter improvements designed to enhance adrulipase’s delayed release profile. This filing adds to the growing intellectual property, IP, portfolio governing adrulipase, which includes patent applications governing adrulipase formulation and methods of use and the utilization of enteric formulations in the delivery of adrulipase. Expansion of the adrulipase patent estate follows the recent submission of an Investigational New Drug amendment seeking authorization from the U.S. Food and Drug Administratio to initiate a Phase 2 clinical trial evaluating an enhanced enteric microgranule delivery formulation of adrulipase as a treatment for exocrine pancreatic insufficiency associated with cystic fibrosis and chronic pancreatitis. "Enhancing the IP portfolio protecting adrulipase and the microgranule drug delivery formulation is an important value-building opportunity for First Wave as we prepare to soon initiate the Phase 2 clinical trial of adrulipase in exocrine pancreatic insufficiency associated with cystic fibrosis and chronic pancreatitis," said James Sapirstein, President and CEO of First Wave BioPharma. "We believe that our reformulation of adrulipase offers the potential to provide a substantially improved treatment option for EPI patients that is differentiated from therapeutics currently used to treat the condition."