Gilead Sciences has debuted 52-week data from a late-stage study on its primary biliary cholangitis (PBC) therapy, Livdelzi (seladelpar), demonstrating the drug’s ability to normalise the levels of a liver enzyme associated with disease progression.
In the Phase III IDEAL study (NCT06060665), Gilead pitted Livdelzi, a selective peroxisome proliferator-activated receptor delta (PPAR-δ) agonist, against placebo in 96 PBC patients with inadequately controlled disease. This means their levels of the liver enzyme, alkaline phosphatase (ALP), were above normal at baseline, despite prior treatment.
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After 52 weeks, significantly more patients in the Livdelzi arm of the trial achieved ALP normalisation compared with placebo. This outcome is often associated with a reduction in the risk of progression to liver transplant or death in PBC.
Livdelzi’s safety and tolerability profile remained similar to prior studies on the drug, with Gilead identifying no new safety concerns tied to its use.
While Gilead has only provided a teaser of the full IDEAL dataset at this time, the company plans to present the full results from the trial at an upcoming medical congress. Gilead will also discuss these results with global regulators.
The topline results debut less than a week after Gilead debuted interim data from the open-label ASSURE study (NCT04620733) on Livdelzi, which found that 74% of patients achieved composite ALP normalisation at the 24-month mark.
These positive outcomes could support Gilead’s ploy to boost Livdelzi’s uptake within the PBC indication, as the company looks to reach a broader group of patients living with the disease.
According to Cynthia Levy, professor of Clinical Medicine and Hepatology, University of Miami Miller School of Medicine, the IDEAL study results “further strengthen support” for Livdelzi’s efficacy and safety in PBC, while “extending the evidence base to a broader population and supporting ALP normalisation as an achievable therapeutic goal” in patients with high levels of the liver enzyme.
Addressing unmet needs in PBC
Currently, the standard of care (SoC) for PBC is ursodeoxycholic acid (UDCA), a naturally occurring bile secretion that acts by improving bile flow and diluting toxic, liver-damaging bile acids to prevent progression.
However, according to clinical practice guidelines from the European Association for the Study of the Liver (EASL), approximately 40% of patients with PBC either exhibit an incomplete response to UDCA or have an intolerance to the drug.
Currently, Gilead claims that Livdelzi is the only drug to have offered statistically significant reductions in PBC disease markers and related itching versus placebo, though it is not the only drug vying for market share in the indication.
Livdelzi is facing direct competition from Ipsen Pharmaceuticals’ PPAR-α/PPAR-δ agonist Iqirvo (elafibranor), which received accelerated approval for use in patients with PBC back in 2024.
However, a new drug, Zydus Therapeutics’ saroglitazar magnesium, could also be set to make a debut on the PBC market. This comes after the therapy posted a win in the Phase IIb/III EPICS-III study (NCT05133336). The fellow PPAR agonist is currently under priority review by US regulators. Zydus expects a decision from the US Food and Drug Administration (FDA) by 27 November 2026.
