First Wave BioPharma announced that the first patient was dosed in the Phase 2 SPAN clinical trial investigating an enhanced enteric microgranule delivery formulation of adrulipase for the treatment of exocrine pancreatic insufficiency in patients with cystic fibrosis. Topline results from the study are anticipated by mid-2023. "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 as the standard of care for EPI associated with CF and chronic pancreatitis," said James Sapirstein, President and CEO of First Wave BioPharma. "With dosing initiated, we now look forward to a topline data readout from the Phase 2 SPAN trial by mid-2023, which we hope will confirm the favorable results produced in the in vitro studies of the enteric microgranule delivery formulation for adrulipase."
Published first on TheFly
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