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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 had reformulated drug delivery to enable improved absorption in the small intestine.

  • The candidate remains is also being developed in combination with PERT in similar indications.

First Wave BioPharma, Inc

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

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