FOSTER CITY, Calif., May 28, 2026
Gilead Sciences announced new interim findings from the ongoing Phase 3 ASSURE study showing that Livdelzi® (seladelpar) achieved high and sustained rates of alkaline phosphatase (ALP) normalization in people living with primary biliary cholangitis (PBC). The new post hoc analysis, presented at the European Association for the Study of the Liver (EASL) Congress 2026 in Barcelona, demonstrated that patients with moderately elevated ALP levels achieved durable biochemical improvements over two years of treatment. The findings strengthen the growing body of evidence supporting Livdelzi as a long-term therapeutic option for PBC patients who remain inadequately controlled on first-line treatment with ursodeoxycholic acid (UDCA).
Long-Term ALP Normalization Supports Disease Control
ALP is widely recognized as one of the most important biomarkers of disease activity in PBC, with elevated levels associated with increased risk of liver disease progression, liver failure, and transplant need. In the interim ASSURE analysis, patients entering the study with ALP levels between 1.0 and 1.67 times the upper limit of normal (ULN) showed substantial and sustained reductions after treatment with Livdelzi.
Among 50 evaluable participants, 83% achieved composite ALP normalization at 12 months, defined as ALP ≤1×ULN combined with at least a 15% reduction from baseline. At 24 months, 74% maintained the same endpoint, demonstrating persistent long-term biochemical response. Researchers also reported improvements in other cholestatic markers including gamma-glutamyl transferase (GGT), while total bilirubin levels remained stable throughout follow-up.
The study population included patients with recognized risk factors for disease progression such as cirrhosis and younger age at diagnosis, highlighting the relevance of the findings in more vulnerable patient groups. Investigators noted that Livdelzi was generally well tolerated, with no treatment discontinuations related to adverse events and no new safety concerns identified during up to two years of observation.
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Exploratory Liver Stiffness Findings Add Further Evidence
In addition to ALP normalization data, exploratory analyses from the broader ASSURE population demonstrated encouraging long-term liver outcomes. Among participants who achieved biochemical response at 12 months and were followed for up to three years, 85% maintained or improved liver stiffness measurements, a non-invasive marker commonly associated with long-term liver health and fibrosis progression.
Researchers believe these findings provide supportive evidence that sustained biochemical improvement with Livdelzi may contribute to broader clinical benefits over time. Cynthia Levy, MD, Professor of Medicine at the University of Miami and Associate Director of the Schiff Center for Liver Diseases, stated that achieving ALP normalization is increasingly viewed as a critical treatment goal in PBC because of its association with improved long-term outcomes. She noted that the data demonstrate Livdelzi’s potential role across a broader range of PBC patients, including individuals with lower but still clinically meaningful ALP elevations.
Swati Tole, MD, MS, Clinical Development lead for inflammation at Gilead Sciences, emphasized that combining ALP normalization with symptom management offers a more comprehensive approach to PBC care. She highlighted the importance of addressing both disease progression markers and debilitating symptoms such as chronic pruritus, which significantly affects quality of life in many PBC patients.
Livdelzi Expands Presence in the PBC Treatment Market
Livdelzi, marketed as Lyvdelzi in certain international regions, is an oral PPAR-delta agonist approved for use in combination with UDCA or as monotherapy in patients unable to tolerate UDCA. The therapy is currently approved across multiple major markets including the United States, United Kingdom, European Economic Area, Switzerland, Canada, Australia, and Israel.
The approvals were primarily supported by data from the pivotal RESPONSE Phase 3 study, which demonstrated significant improvements in ALP levels and symptom control. Additional long-term findings from ASSURE continue to reinforce Livdelzi’s safety and efficacy profile across broad PBC patient populations.
Founded as one of the leading global liver disease companies, Gilead Sciences continues expanding its hepatology portfolio beyond viral hepatitis into autoimmune liver diseases such as PBC. The latest EASL 2026 data further strengthen the company’s position in the growing global market for chronic liver disease therapeutics.
Source: Gilead Sciences press release
