Gilead Sciences, Inc. (NASDAQ) on Tuesday released results from the Phase 3 IDEAL study in people with primary biliary cholangitis (PBC).

The study showed that treatment with Livdelzi (seladelpar) resulted in significantly more patients achieving normalization of alkaline phosphatase (ALP), a key liver marker associated with disease progression, compared with placebo after 52 weeks.

The primary endpoint was defined as a composite of ALP ≤1.0× the upper limit of normal (ULN) and a ≥15% decrease from baseline.

Results Support Use In Underrepresented PBC Patient Population

The findings were observed in people with inadequately controlled disease, defined as having ALP levels above the ULN and below 1.67×ULN, with an incomplete response or intolerance to ursodeoxycholic acid (UDCA).

This patient population has been underrepresented in previous randomized trials despite being commonly encountered in clinical practice.

The safety profile of seladelpar observed in the IDEAL study was consistent with previously reported Livdelzi studies, with no new safety concerns identified.

Experts Highlight Growing Evidence For Livdelzi

"These results extend the evidence base for Livdelzi to a broader population of people living with PBC and support ALP normalization as an achievable therapeutic goal in patients with ALP between 1 to 1.67xULN," said Cynthia Levy, Professor of Clinical Medicine and Hepatology, University of Miami Miller School of Medicine.

ALP Normalization Emerges As Key Treatment Goal

In PBC, ALP is a key disease marker associated with disease activity and long-term outcomes.

ALP levels above normal, including those in the 1.0 to 1.67×ULN range, are associated with a higher risk of progression to liver transplant or death compared with normalized ALP levels.

Regulatory Discussions Planned Following Data Presentation

Gilead said full data from the IDEAL study will be presented at an upcoming medical congress. The company also plans to engage with global regulatory authorities to discuss the results.

Last week, Gilead Sciences shared new results from a post hoc analysis showing that Livdelzi was associated with high and sustained rates of normalization of a key liver marker (ALP) for PBC.

In an ongoing ASSURE Phase 3 study, participants with elevated ALP levels (between 1.0 and 1.67×ULN) experienced reductions in ALP after treatment.

Among 50 participants, 83% of evaluable participants achieved composite ALP normalization at 12 months, and 74% achieved the same endpoint at 24 months, demonstrating a persistent response over two years of treatment.

GILD Price Action: Gilead Sciences shares were down 2.01% at $128.47 at the time of publication on Tuesday, according to Benzinga Pro data.

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