89bio Receives EMA PRIME Status for Pegozafermin in the Treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH) with Fibrosis and Compensated Cirrhosis

–PRIME status is supported by positive data from the Phase 2b ENLIVEN trial of pegozafermin–

–Phase 3 ENLIGHTEN-Fibrosis trial in non-cirrhotic MASH (fibrosis stage F2-F3) patients is enrolling and ENLIGHTEN-Cirrhosis in MASH patients with compensated cirrhosis (F4) is planned to initiate in the second quarter of 2024–

SAN FRANCISCO, March 27, 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 that the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) status to pegozafermin in patients with MASH. The PRIME status was supported by positive data from the Phase 2b ENLIVEN trial of pegozafermin in patients with non-cirrhotic MASH with fibrosis (F2-F3) and MASH with compensated cirrhosis (F4).

“The EMA PRIME status further supports pegozafermin’s positioning as a leading FGF21 analog for the treatment of MASH, which has demonstrated robust anti-fibrotic and metabolic benefits as seen in our Phase 2b ENLIVEN trial,” said Rohan Palekar, Chief Executive Officer of 89bio. “This status recognizes the urgent need for effective treatment options for MASH patients with advanced fibrosis and underscores pegozafermin’s potential to address the targeted unmet medical need. We look forward to working closely with regulatory agencies as we continue to advance our Phase 3 clinical development program, ENLIGHTEN, aimed at potentially benefiting advanced MASH patients and MASH patients with compensated cirrhosis.”

The PRIME status is granted by the EMA to provide early and proactive support to developers of promising medicines that, based on clinical data, may offer a major therapeutic advantage over existing treatments, or benefit patients without treatment options. PRIME aims to provide multiple benefits so that these medicines can reach patients earlier including, enhanced interaction and early dialogue with EMA, guidance on the overall development plan and regulatory strategy, and the potential for accelerated assessment of the time of marketing authorization application.