89bio Initiates Phase 3 ENLIGHTEN-Cirrhosis Trial of Pegozafermin in Metabolic Dysfunction-Associated Steatohepatitis (MASH) Patients with Compensated Cirrhosis

—With the initiation of ENLIGHTEN-Cirrhosis, pegozafermin is the first FGF21 analog to enter a Phase 3 trial in MASH patients with compensated cirrhosis (F4)—

—Regression of fibrosis by histology at month 24 will serve as the basis for potential accelerated approval with clinical outcomes to support the potential for confirmatory or full approval—

SAN FRANCISCO, May 14, 2024 (GLOBE NEWSWIRE) -- 89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardiometabolic diseases, today announced the initiation of ENLIGHTEN-Cirrhosis, a Phase 3 trial of pegozafermin in patients with MASH with compensated cirrhosis (F4).

“MASH patients with compensated cirrhosis are in critical need of effective therapies that can halt and ideally reverse the progression of fibrosis to prevent the onset of liver decompensation,” said Arun J. Sanyal, MBBS, M.D., Director of the Stravitz-Sanyal Institute for Liver Disease and Metabolic Health, Virginia Commonwealth University. “Due to its demonstrated anti-fibrotic benefits, pegozafermin has the potential to be uniquely positioned to meet the needs of compensated cirrhotic MASH patients and could reduce the risk of decompensation. I look forward to evaluating the potential benefits of pegozafermin in this Phase 3 trial given the severity of symptoms this patient population experiences.”

ENLIGHTEN-Cirrhosis is a global Phase 3, randomized, double-blind, placebo-controlled trial evaluating pegozafermin for the treatment of MASH patients with compensated cirrhosis (F4). The trial will enroll approximately 760 patients, who will be randomized in a 1:1 ratio to either receive 30mg of pegozafermin administered weekly or a placebo. The interim analysis primary endpoint of fibrosis regression is defined as improvement in fibrosis from F4 to an earlier stage. A subset of the 760 patients will be evaluated at 24 months to assess fibrosis regression, potentially supporting an accelerated approval filing in the United States and conditional approval in Europe. The trial will continue to monitor all participants until a pre-defined number of clinical outcome events are observed. The primary endpoint for the final analysis will be a clinical outcome composite and is expected to form the basis for confirmatory or full approval for MASH patients at both stage F4 and as well as stages F2-F3. Based on prior discussions and alignment with regulatory agencies on the modified definitions of cirrhosis clinical outcome events, the timeline for reaching the expected number of events could be expedited compared to previous Phase 3 trials that have been conducted in MASH patients with compensated cirrhosis.