First Wave files IND for microgranule delivery formulation of adrulipase

First Wave BioPharma announced that it has submitted an Investigational New Drug, IND, application seeking authorization from the U.S. Food and Drug Administration, FDA, to evaluate an enhanced enteric microgranule delivery formulation of adrulipase as a treatment for exocrine pancreatic insufficiency associated with cystic fibrosis and chronic pancreatitis in human clinical trials. Upon IND clearance, First Wave expects to initiate a Phase 2 trial at the beginning of 2023. "Filing the IND is an important step in enabling First Wave to initiate the planned Phase 2 trial of our new formulation for adrulipase," said James Sapirstein, President and CEO of First Wave BioPharma. "If the FDA grants authorization in the next 30 days, we expect to start the study in early 2023 with topline data anticipated towards the end of the first half of 2023. We anticipate that these near-term clinical milestones will reinforce our previous research, such as data recently presented at AAPS 2022 showing the new adrulipase formulation can deliver the drug in the intended area of the gastrointestinal tract, where it can provide the desired therapeutic effect," Sapirstein added. "We look forward to investigating this potential in a Phase 2 clinical trial and the opportunity to one day provide therapeutic relief to patients with exocrine pancreatic insufficiency associated with cystic fibrosis and chronic pancreatitis."