Gilead's Livdelzi Shows Positive Phase 3 IDEAL Trial Results In Biliary Cholangitis

Gilead's Livdelzi demonstrates encouraging Phase 3 IDEAL results for primary biliary cholangitis, a chronic autoimmune liver disease. The double-blind, placebo-controlled IDEAL trial enrolled 96 adults aged 18 to 75 who had elevated alkaline phosphatase levels despite UDCA therapy or intolerance, and followed them for 52 weeks. The primary endpoint was ALP normalization, defined as ALP at or below 1.0× ULN with a concurrent ≥15% reduction from baseline for those above ULN. In the results disclosed by Gilead, significantly more patients on Livdelzi achieved ALP normalization compared with placebo. Livdelzi, also known as seladelpar, is an investigational oral PPAR-delta agonist being developed for PBC. Full IDEAL data will be presented at an upcoming medical congress and discussed with global regulators.