Gilead's Livdelzi Shows Long-Term Efficacy and Safety in Primary Biliary Cholangitis

Gilead Sciences, Inc. shared two-and-a-half-year interim results from the Phase 3 ASSURE study, revealing that 81% of participants with primary biliary cholangitis (PBC) treated with Livdelzi (seladelpar) achieved a significant composite biochemical response (CBR). Additionally, 41% saw normalization of alkaline phosphatase (ALP) levels, a key liver function biomarker. These results were presented at The Liver Meeting 2024 hosted by the American Association for the Study of Liver Diseases (AASLD) in San Diego.

The ASSURE study, an open-label trial with ongoing enrollment, is assessing the long-term efficacy and safety of Livdelzi in adults with PBC who had an inadequate response or intolerance to ursodeoxycholic acid (UDCA). This interim analysis, based on data up to January 31, 2024, included participants from previous Livdelzi clinical studies and the pivotal Phase 3 RESPONSE study. The safety profile of Livdelzi remains strong, showing no treatment-related serious adverse events (SAEs) throughout the study. The incidence of adverse events decreased over time, indicating Livdelzi's general tolerability over three years of exposure.

Dr. Eric J. Lawitz, principal investigator and Medical Director of the Texas Liver Institute, emphasized the significance of these findings, noting that consistent ALP reduction offers a promising treatment option for those with PBC. He highlighted that ALP levels are critical markers for liver health, and normalizing these levels can substantially improve disease management for patients not responding to first-line therapies.

Additional data from the Phase 3 RESPONSE trial were also showcased, including a subgroup analysis of Livdelzi's efficacy and safety in PBC patients with compensated cirrhosis. Results demonstrated substantial ALP reductions compared to placebo, with adverse event rates similar across both groups. Another analysis focused on pruritus showed Livdelzi significantly alleviated itching compared to placebo, contributing to improved quality of life for participants.

Timothy Watkins, MD, Vice President of Clinical Development at Gilead Sciences, highlighted Livdelzi’s groundbreaking role as the first treatment to show significant improvements in both pruritus and markers of cholestasis. He underlined Gilead's commitment to providing innovative therapies that offer hope and better outcomes for those with PBC.

Gilead also presented a separate analysis from a comprehensive safety database, demonstrating Livdelzi's tolerability over five years of treatment. The data encompassed 486 participants who received Livdelzi and 152 who received placebo, showing no treatment-related SAEs.

Livdelzi, an oral PPAR-delta agonist, received accelerated approval from the U.S. Food and Drug Administration (FDA) in August 2024 for treating PBC. The approval was based on its ability to significantly reduce ALP levels, with further long-term outcomes studies required to confirm its clinical benefits. Livdelzi has also been granted FDA Breakthrough Therapy Designation and Orphan Drug Designation, and it is under review by the UK Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA).

Gilead Sciences, headquartered in Foster City, California, has a long-standing history of innovative treatments for liver diseases. The company’s achievements include transforming hepatitis C into a curable condition and advancing treatments for hepatitis B and D. Gilead continues to strive for a future without liver disease through its pioneering science and collaborative efforts.