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First Wave’s Adrulipase Disappoints In Third Phase II CF EPI Trial Despite New Formulation

Stock Down By 39%

 
• By Ayisha Sharma

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.  

graphic image of fat cells
Adrulipase Is Designed To Break Up Fat Molecules In The Digestive Tract • Source: Shutterstock
Key Takeaways:

  • Adrulipase was safe and tolerable but early results suggest it missed the primary endpoint.

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.

EPI is caused by a deficiency in exocrine pancreatic enzymes, leading to maldigestion and symptoms such as diarrhea, fecal urge...

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