Gilead Sciences Reports Phase 3 IDEAL Success For Livdelzi In PBC, With 75.4% Achieving ALP Normalization At Week 52 Vs 16.1% Placebo; Serious Adverse Events 3.1% Livdelzi Vs 12.9% Placebo; None Related To Drug
Benzinga Newsdesk 3 hours ago
BiotechGeneralNews
- Data to be Presented at The Liver Meeting® Demonstrate Rapid and Sustained Improvements in ALP Levels with Livdelzi in Adults with PBC and ALP Levels Between 1-1.67× ULN, Despite Receiving UDCA or with Intolerance to
- Data to be Presented at The Liver Meeting® Demonstrate Rapid and Sustained Improvements in ALP Levels with Livdelzi in Adults with PBC and ALP Levels Between 1-1.67× ULN, Despite Receiving UDCA or with Intolerance to UDCA -
- Gilead Will Engage Global Regulatory Authorities Based on These Results -
Gilead Sciences, Inc. (NASDAQ:GILD) today announced the detailed results from the Phase 3 IDEAL study, which demonstrated that the majority of participants living with PBC and treated with Livdelzi® (seladelpar) achieved the alkaline phosphatase (ALP) normalization composite endpoint defined as a composite of ALP ≤ 1.0× upper limit of normal (ULN) and a ≥ 15% decrease from baseline. ALP is a key marker of disease activity and long-term outcomes in PBC. These results can expand understanding of treatment effects and inform evolving treatment goals for people living with PBC.
Key Highlights
- At Week 52, 75.4% (49/65) of participants who received Livdelzi achieved the ALP normalization composite endpoint versus 16.1% (5/31) of participants receiving placebo.
- Results will be presented at The Liver Meeting® 2026, hosted by the American Association for the Study of Liver Diseases (AASLD), November 5-9 in Denver, Colorado, and have been accepted for upcoming publication in the Journal of Hepatology.
- Gilead is engaging with global regulatory authorities to discuss these results.
IDEAL is a Phase 3, randomized, double‑blind, placebo‑controlled clinical study evaluating Livdelzi in adults living with PBC who have ALP levels above normal yet below the 1.67× ULN threshold typically required for inclusion in other PBC randomized controlled trials (RCTs). It is the first clinical trial to evaluate Livdelzi in people with inadequately controlled disease defined as ALP levels of 1-1.67× ULN despite receiving ursodeoxycholic acid (UDCA) for 12 months or with intolerance to UDCA.