First Wave BioPharma, Inc.’s improved formulation of its lead candidate adrulipase has disappointed in a Phase IIb trial of patients with exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF), rendering its future as a monotherapy uncertain in the roughly $2.2bn market.
First Wave’s Adrulipase Disappoints In Third Phase II CF EPI Trial Despite New Formulation
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The US firm’s lead gastrointestinal asset has missed the mark in a mid-stage exocrine pancreatic insufficiency trial in cystic fibrosis patients despite its best efforts to enhance the formulation after two prior setbacks.
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A decision from the FDA is due by 28 September.