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
Stock Down By 39%
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.

More from Clinical Trials
With new Phase II data, Edgewise asserted that EDG-7500, a sarcomere modulator, could offer better efficacy and safety than cardiac myosin inhibitors in hypertrophic cardiomyopathy.
Investing heavily in antibody-drug conjugates, AbbVie is pioneering a dual STEAP1xPSMA-targeting approach in prostate cancer, as other candidates advance.
Strong sales growth for the German group’s SGLT2 inhibitor in 2024
After a more than three-year hiatus, China's Hengrui has signalled its return to multiregional Phase III trials as it looks to globalize its innovative pipeline. Meanwhile, a number of other Chinese players have announced plans to kick off Phase III trials this year and beyond.