$89bio (ETNB.US)$ NEWS 89bio Initiates Phase 3 ENLIGHTEN-Cir...
NEWS
89bio Initiates Phase 3 ENLIGHTEN-Cirrhosis Trial of Pegozafermin in Metabolic Dysfunction-Associated Steatohepatitis (MASH) Patients with Compensated Cirrhosis
89bio has initiated the Phase 3 ENLIGHTEN-Cirrhosis trial for pegozafermin in patients with MASH and compensated cirrhosis (F4). This is the first FGF21 analog to reach this trial stage for this patient subset. The trial will involve 760 patients, assessing fibrosis regression at 24 months, potentially supporting accelerated approval in the U.S. and Europe. The trial's primary goal is to observe clinical outcome events for confirmatory or full approval. The ENLIGHTEN-Cirrhosis trial builds on promising Phase 2b results showing improvements in liver health markers, aiming to meet the urgent need for effective therapies in MASH with compensated cirrhosis.
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