Gilead Sciences reported positive Phase 3 IDEAL study results for Livdelzi (seladelpar) in treating primary biliary cholangitis (PBC).
The trial met its primary endpoint after 52 weeks. Livdelzi achieved statistically significant normalization of alkaline phosphatase (ALP) compared to a placebo. ALP serves as a key marker for disease progression.
The study focused on patients who are intolerant of or have an inadequate response to standard first-line treatments. This population is common in clinical practice but often underrepresented in previous trials.
The safety profile remained consistent with prior studies and revealed no new concerns. Gilead plans to present full results at a future medical conference. The company will also discuss these findings with global regulators.