89bio Commences P-III Study of Pegozafermin for Treating Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Shots:
- 89bio has initiated a P-III (ENLIGHTEN-Fibrosis) study investigating the safety & efficacy of pegozafermin (30mg, QW or 44mg, Q2W) vs PBO to treat non-cirrhotic MASH patients (n=1000) with fibrosis (F2-F3). The (ENLIGHTEN-Cirrhosis) program for compensated cirrhosis (F4) is anticipated in Q2’24
- The co-primary endpoints (at wk.52) include improvement in fibrosis without worsening MASH & MASH resolution without worsening fibrosis. The data aims to support accelerated & conditional approval in the US & the EU, respectively, for non-cirrhotic patients. Treatment will continue for full approval
- The 2EPs of the study are noninvasive tests (NITs), additional histological endpoints as well as metabolic & lipid evaluation
Ref: 89bio | Image: 89bio
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
