Gilead’s Livdelzi Achieves Significant ALP Normalization in 52-Week Trial
GILD•Livdelzi normalized alkaline phosphatase in significantly more of 96 PBC patients after 52 weeks in the Phase III IDEAL trial versus placebo. Safety and tolerability matched previous studies, and Gilead plans to present full IDEAL results at an upcoming medical congress while engaging regulators.
1. IDEAL Study Demonstrates ALP Normalization
In the 96-patient Phase III IDEAL study, 52-week data show a statistically significant increase in alkaline phosphatase normalization rates for Livdelzi versus placebo in patients with inadequately controlled PBC, indicating potential to reduce progression risk.
2. Consistent Safety and Tolerability Profile
Livdelzi’s safety and tolerability in the IDEAL trial aligned with prior studies, with no new adverse events identified, supporting the drug’s established risk profile for PBC patients.
3. Full Data Release and Regulatory Strategy
Gilead will present the complete IDEAL dataset at an upcoming medical congress and is engaging global regulators to review the full results, paving the way for potential label expansions.
4. Expansion Potential in PBC Market
Positive IDEAL results and interim ASSURE findings showing 74% composite ALP normalization at 24 months could help Livdelzi address the estimated 40% of PBC patients with inadequate response to standard UDCA therapy and strengthen Gilead’s position in the market.
