SAN FRANCISCO - 89bio, Inc. (NASDAQ:ETNB), a biopharmaceutical company, announced today the initiation of its Phase 3 ENLIGHTEN Program to evaluate pegozafermin for metabolic dysfunction-associated steatohepatitis (MASH) treatment. The first trial, ENLIGHTEN-Fibrosis, will focus on non-cirrhotic MASH patients with fibrosis stages F2-F3, aiming to enroll approximately 1,000 participants globally.
The trial is a randomized, double-blind, placebo-controlled study designed to assess the efficacy and safety of pegozafermin, with co-primary endpoints to be evaluated at week 52. These endpoints include a one-point improvement in fibrosis without worsening of MASH and MASH resolution without worsening fibrosis. The results will potentially support accelerated approval in the U.S. and conditional approval in Europe.
Dr. Rohit Loomba, Chief of Gastroenterology and Hepatology at the University of California San Diego School of Medicine, highlighted the need for therapeutic options that improve liver health and offer anti-fibrotic benefits for MASH patients. Pegozafermin, a fibroblast growth factor 21 (FGF21) analog, has shown anti-fibrotic and metabolic effects in the Phase 2b ENLIVEN trial.
The ENLIGHTEN-Cirrhosis trial, the second in the program, is planned to initiate in the second quarter of 2024 to evaluate patients with compensated cirrhosis (F4). Key secondary endpoints of the trials include additional histological endpoints, noninvasive tests, and metabolic and lipid assessments.
MASH is a chronic disease characterized by fat accumulation in the liver, leading to fibrosis and potentially severe liver-related complications. It is often asymptomatic until advanced stages and is a leading cause of liver transplants among adults.
Pegozafermin has received Breakthrough Therapy designation from the FDA for the treatment of MASH with fibrosis. The drug is also being studied in the Phase 3 ENTRUST trial for severe hypertriglyceridemia (SHTG).
The information is based on a press release statement from 89bio, Inc.
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