89bio, Inc. (Nasdaq: ETNB) has announced the completion of enrollment in its Phase 3 ENTRUST trial evaluating pegozafermin for severe hypertriglyceridemia (SHTG) and provided an update on its ongoing ENLIGHTEN Phase 3 program in metabolic dysfunction-associated steatohepatitis (MASH). Topline data from the ENTRUST trial is anticipated in the second half of 2025.
The ENTRUST trial is designed to assess the efficacy, safety, and tolerability of pegozafermin in patients with SHTG. SHTG is a condition characterized by severely elevated triglyceride levels, increasing the risk of cardiovascular events. Currently, treatment options are limited, highlighting the unmet medical need.
ENLIGHTEN Program进展
The ENLIGHTEN program consists of two Phase 3 trials: ENLIGHTEN-Fibrosis, focusing on non-cirrhotic (F2-F3) MASH patients with fibrosis, and ENLIGHTEN-Cirrhosis, targeting compensated cirrhotic (F4) MASH patients. Enrollment is ongoing in both studies, which are being conducted globally. MASH represents a significant and growing health concern, affecting millions worldwide and often progressing to cirrhosis and liver failure.
Regulatory and Financial Updates
89bio has received regulatory feedback from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) regarding clinical and Chemistry, Manufacturing, and Controls (CMC) requirements for potential marketing authorization filings for pegozafermin. The company remains on track for potential Biologics License Application (BLA) and Marketing Authorization Application (MAA) submissions, contingent upon positive clinical data.
As of December 31, 2024, 89bio reported approximately $440 million in cash, cash equivalents, and marketable securities (preliminary unaudited). This strong financial position is supported by a completed equity follow-on offering for $143.8 million and an amended credit facility providing up to $150.0 million.
Executive Leadership
89bio has recently strengthened its executive leadership team with the appointments of Teresa Perney, Ph.D., as Chief Regulatory and Quality Officer, and Francis Sarena as Chief Operating Officer. Additionally, Charles McWherter, Ph.D., and Martin Babler have joined the Board of Directors. These additions bring extensive operational, clinical, regulatory, and commercial expertise to the company.
Pegozafermin: A Novel FGF21 Analog
Pegozafermin is a specifically engineered fibroblast growth factor 21 (FGF21) analog with unique glycoPEGylated technology designed to optimize biological activity through an extended half-life. FGF21 is a metabolic regulator that has shown promise in improving multiple aspects of cardiometabolic health. "We remain confident in pegozafermin’s potential as a potent anti-fibrotic agent with broad cardio-metabolic benefits," said Rohan Palekar, CEO of 89bio.
With Phase 3 trials underway and a solid financial foundation, 89bio is positioning itself to potentially transform the treatment landscape for patients with MASH and SHTG.
