89bio to Present 48-Week Phase 2b Pegozafermin Trial Data in MASH at EASL Congress

89bio, Inc., a clinical-stage biopharmaceutical company, announced the upcoming presentation of data from the 48-week extension phase of its Phase 2b ENLIVEN trial. This study evaluates pegozafermin, a fibroblast growth factor 21 (FGF21) analog, in patients with metabolic dysfunction-associated steatohepatitis (MASH) with fibrosis. The data will be showcased in both oral and poster presentations at the European Association for the Study of the Liver (EASL) Congress, scheduled from June 5 to 8, 2024, in Milan, Italy.

Dr. Hank Mansbach, Chief Medical Officer of 89bio, highlighted the significance of these findings, stating that pegozafermin is the first FGF21 analog to demonstrate consistent, positive outcomes over a 48-week period in advanced MASH patients. These data suggest sustained efficacy and tolerability, underscoring the potential for long-term benefits which will be further examined in the ongoing Phase 3 program.

The ENLIVEN trial involved patients with biopsy-confirmed MASH and F2/F3 fibrosis, who were administered pegozafermin on either a 30mg weekly or 44mg every-two-week dosing schedule. The trial's primary and secondary outcomes included improvements in liver health markers, liver fat reduction, and glycemic control. The 48-week data showed statistically significant benefits consistent with the 24-week results, affirming sustained positive effects over the extended treatment period.

The oral presentation, titled "Week 48 results from the Phase 2b ENLIVEN extension study investigating pegozafermin for the treatment of metabolic dysfunction-associated steatohepatitis with fibrosis," will be delivered by Dr. Rohit Loomba from the University of California San Diego School of Medicine on June 8th. Additionally, Dr. Arun J. Sanyal from Virginia Commonwealth University will present a poster titled "Pegozafermin added to background GLP-1 therapy in patients with metabolic dysfunction-associated steatohepatitis with F2/F3 fibrosis: ENLIVEN 48-week extension data," on the same day.

MASH, also known as nonalcoholic steatohepatitis (NASH), is a severe liver condition characterized by fat accumulation and inflammation, potentially leading to fibrosis and serious complications such as cirrhosis. It is projected to affect over 27 million people in the U.S. by 2030. With limited treatment options available, the development of effective therapies like pegozafermin is crucial.

The ENLIVEN trial was a double-blind, placebo-controlled study involving 192 patients who received varying doses of pegozafermin or a placebo. At the 24-week mark, key liver health markers showed significant improvement in those treated with pegozafermin. During the blinded extension phase, patients continued treatment for an additional 24 weeks. The results confirmed sustained benefits in liver fat and non-invasive markers of liver fibrosis and inflammation. Notably, pegozafermin achieved high statistical significance in primary histology endpoints, and these findings were published in the New England Journal of Medicine.

Pegozafermin, under development for MASH and severe hypertriglyceridemia (SHTG), is a glycoPEGylated FGF21 analog with promising clinical trial results. It has shown direct anti-fibrotic and anti-inflammatory effects, reduced triglyceride levels, improved insulin resistance, and maintained a favorable safety profile. The FDA has granted it Breakthrough Therapy designation, and the European Medicines Agency has given it Priority Medicines status for MASH treatment.

89bio, headquartered in San Francisco, is focused on advancing pegozafermin through clinical trials. The company aims to provide effective therapies for liver and cardiometabolic diseases, addressing significant unmet medical needs.