2023-03-09 09:25:44 ET
- First Wave BioPharma ( NASDAQ: FWBI ) said the first patient was dosed in phase 2 trial of an enhanced enteric microgranule delivery formulation of adrulipase to treat exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF).
- EPI is a condition in which the pancreas does not make enough enzymes that are required to break down and absorb nutrients. Meanwhile, CF is an inherited disorder which causes damage to the lungs, digestive system and other organs.
- The study, dubbed SPAN, is expected to enroll 12 patients
- "Dosing of the first patient in the Phase 2 SPAN clinical trial is a significant milestone for First Wave BioPharma and a key inflection point towards our goal of developing adrulipase to one day replace porcine-derived pancreatic enzyme replacement therapy (PERT) as the standard of care for EPI associated with CF and chronic pancreatitis," said First Wave President and CEO James Sapirstein.
- The company expects topline data from the trial by mid-2023.
- FWBI +17.46% to $4.17 premarket March 9
For further details see:
First Wave stock surges ~15% as dosing starts in pancreas disorder trial