Gilead Sciences: Phase 3 ASSURE Interim data: majority of people in the study with ALP 1-1.67ULN achieved high and sustained composite ALP normalization at 24 months with Gilead's Livdelzi (seladelpar)

[출처/시간] Briefing.com - 6:01 AM ET, 05/27/2026

Co shared new results from a post hoc analysis showing that Livdelzi was associated with high and sustained rates of normalization of a key liver marker (ALP) in people living with primary biliary cholangitis.In an ongoing Phase 3 study, participants with elevated ALP levels (between 1.0 and 1.67ULN) experienced reductions in ALP after treatment. These data highlight the potential role of Livdelzi in people with PBC who continue to have elevated ALP despite prior treatment with first-line therapy.These findings are highly relevant for people living with PBC with inadequately controlled disease based on elevated ALP levels-a population historically underrepresented in randomized clinical trials. The data will be presented at the European Association for the Study of the Liver Congress 2026, held May 27--30 in Barcelona, Spain."Achieving ALP normalization is increasingly recognized as a key treatment goal in PBC due to its association with improved long-term clinical outcomes," said Cynthia Levy, MD, Professor of Medicine in the Division of Digestive Health and Liver Diseases, and Associate Director of the Schiff Center for Liver Diseases at the University of Miami. "These data show that seladelpar can help people who have not reached ALP normalization achieve this important biochemical target and support its potential role across a broader range of people living with PBC, including those with lower ALP levels."
ASSURE is an ongoing, open-label Phase 3 study evaluating the long-term safety and efficacy of Livdelzi in people living with PBC who previously participated in Livdelzi clinical trials. In an interim post hoc analysis, a high and sustained reduction in ALP was observed with Livdelzi treatment in participants with elevated baseline ALP levels between 1.0 and 1.67ULN. Among 50 participants, 83% of evaluable participants achieved composite ALP normalization-defined as ALP =1ULN with =15% reduction-at 12 months, and 74% achieved the same endpoint at 24 months, demonstrating a persistent response over two years of treatment.Mean ALP levels declined substantially from baseline and remained reduced through long-term follow-up. Improvements were also observed in other markers of cholestasis, including gamma-glutamyl transferase, and total bilirubin remained stable overall.This population included individuals with recognized risk factors for disease progression, including cirrhosis and younger age at diagnosis. Livdelzi was found to be generally well tolerated, with no treatment discontinuations due to adverse events with up to two years of follow-up and no new safety signals observed, consistent with previously reported findings.Separately, in an exploratory analysis across the full ASSURE population, 85% (n=77/91) of participants who achieved biochemical response at 12 months and were followed up through 3 years maintained or improved liver stiffness measurements. Liver stiffness stability is a commonly used non-invasive marker associated with long-term outcomes and is descriptive in nature in this open-label analysis.