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

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14 Jul 2023

• 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...