ETNB - 89bio to Present 48-Week Data from ENLIVEN Phase 2b Pegozafermin Trial in Metabolic Dysfunction-Associated Steatohepatitis (MASH) at EASL International Liver Congress | Benzinga
SAN FRANCISCO, May 22, 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 data from the 48-week extension phase of the Phase 2b ENLIVEN trial evaluating pegozafermin in patients with metabolic dysfunction-associated steatohepatitis (MASH) with fibrosis will be presented in an oral and poster presentation at the European Association for the Study of the Liver (EASL) Congress to be held June 5 to 8, 2024 in Milan, Italy.
"These data, which are being presented for the first time in a scientific setting, establish pegozafermin as the first FGF21 analog candidate to demonstrate positive, sustained benefits over a 48-week period in patients with advanced MASH," said Hank Mansbach, Chief Medical Officer of 89bio. "In addition, these data highlight the observed long-term efficacy, tolerability and sustained improvement in key liver health markers, that we aim to confirm in our ongoing Phase 3 program."
Presentation details are as follows:
Abstract Title: Week 48 results from the Phase 2b ENLIVEN extension study investigating pegozafermin for the treatment of metabolic dysfunction-associated steatohepatitis with fibrosis
Abstract Number: 943
Format: Oral presentation
Presenting Author: Rohit Loomba, M.D., MHSc, Chief of the Division of Gastroenterology and Hepatology at University of California San Diego School of Medicine, and lead investigator of the ENLIGHTEN program
Presentation Date and Time: Saturday, June 8th 10:45-12:00 CET
About the Abstract: The Phase 2b ENLIVEN trial evaluated the efficacy and safety of pegozafermin in MASH patients with biopsy-proven F2/F3 fibrosis. After the main study, patients began a 24-week blinded extension phase for a total of 48 weeks of treatment. At week 48, both the 30mg weekly and 44mg every-two-week dosing schedules of pegozafermin demonstrated statistically significant improvements across key markers of liver health. The benefits observed at week 48 were consistent with the results observed at week 24, indicating sustained benefits over time.
Abstract Title: Pegozafermin added to background GLP-1 therapy in patients with metabolic dysfunction-associated steatohepatitis with F2/F3 fibrosis: ENLIVEN 48-week extension data
Abstract Number: 1268
Format: Poster presentation
Presenting Author: Arun J. Sanyal, MBBS, M.D., Professor, Departments of Medicine, Physiology, and Molecular Pathology, Virginia Commonwealth University and lead investigator of the ENLIVEN trial
Presentation Date and Time: Saturday, June 8th 8:30-17:00 CET
About the Abstract: A sub analysis of the Phase 2b ENLIVEN trial extension phase was conducted for patients on background GLP-1 therapy. Patients entering ENLIVEN on background GLP-1 therapies were required to have been on a stable regimen for at least six months. Consistent with results observed in the Main Study, patients on background GLP-1 therapy who received pegozafermin continue to derive a greater benefit on markers of liver fibrosis, liver injury/inflammation, liver fat and lipids, compared to patients who continued GLP-1 therapy in the placebo group.
Poster Tour: ...