DENVER (UNITED STATES) (TALPRESS) – Gilead Sciences has announced the detailed results of Phase 3’s IDEAL study, which have shown that most participants with primitive biliary colangitis (PBC) treated with Seladelpar have reached the composite endpoint of normalization of alkaline phosphasis (ALP), defined as the combination of achieving ALP = 1 The ALP is an important marker of disease activity and long-term clinical outcomes in the PBC. These results help to broaden the understanding of the effects of treatment and can support the evolution of therapeutic goals for people living with PBC. On week 52, 75.4% (49/65) of participants treated with Seladelpar reached the composite endpoint of standardization of the ALP, compared to 16.1% (5/31) of participants who received placebo. The results were presented during the The Liver Meeting 2026, organized by the American Association for the Study of Liver Diseases (AASLD), held from 5 to 9 November in Denver, Colorado, and were accepted for a forthcoming publication in the Journal of Hepatology.
Gilead is currently engaged in a dialogue with international regulators to discuss these results. The IDEAL study is a clinical trial of Phase 3, randomized, double-blind and placebo-controlled, aimed at evaluating Seladelpar in adults with PBC with ALP levels above the norm but below the threshold of 1,67×ULN, generally required for inclusion in other randomized and controlled clinical trials (RCTs) on PBC.
It is the first clinical study to evaluate Seladelpar in persons with unsuitably controlled disease, defined by ALP levels between 1 and 1,67x ULN, despite at least 12 months of treatment with ursodesoxylic acid (UDCA) or in the presence of UDCA intolerance. “People with PBC who have high alkaline phosphates, but below 1,67x the upper limit of the norm, were largely excluded from previous studies on second-line therapies,” said Cynthia Levy, MD, University of Miami Miller School of Medicine.
“IDEAL provides randomized and placebo controlled evidence that shows how Seladelpar can improve the biochemical response in this population. These results can support customized discussions on treatment, taking into account the individual risk of disease progression, symptoms and potential risks and benefits of additional treatment,” he added. ALP is a fundamental indicator of disease activity; levels above the norm are associated with an increased risk of disease progression and to worse long-term clinical outcomes such as liver failure. Historically, the inclusion threshold in clinical trials was represented by ALP levels higher than 1,67× ULN. The latest clinical guidelines recognize the normalization of the ALP as the ideal therapeutic target in the PBC.
The results of the IDEAL study expand the basis of evidence by demonstrating that a significantly greater proportion of patients with ALP basal values between 1 and 1,67× ULN treated with Seladelpar can achieve the normalization of the ALP compared to the placebo. The answer was evident already after a month of treatment (52.3% vs 6.5% with placebo) and was maintained until week 52. “The IDEAL study assessed the impact of second-line treatment in people with PBC having lower ALP base levels than those observed in previous clinical studies – said Swati Tole, MD, MS, Senior Vice President, Clinical Development, Inflammation, Gilead Sciences –. A significantly higher percentage of patients with high ALP levels, but lower than the generally studied threshold, obtained the normalization of the ALP with Seladelpar, supporting this parameter as a concretely accessible therapeutic target. Along with the broadest clinical program dedicated to Seladelpar, IDEAL reinforces the importance of continuing to raise the PBC cure standards in a wide range of patients.”.
The safety profile of Seladelpar observed in the IDEAL study was consistent with the one that emerged in previous studies on the drug and no new safety signs were identified. The incidence of adverse events was generally similar in Seladelpar and placebo groups; serious adverse events were reported in 3.1% and 12.9% of participants respectively and none of them was considered related to treatment in study.
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