Gilead Sciences has announced positive two-and-a-half-year interim results from the Phase III ASSURE trial, evaluating Livdelzi (seladelpar) for the treatment of primary biliary cholangitis (PBC). The open-label study, designed to assess the long-term efficacy and safety of Livdelzi, enrolled up to 500 participants with PBC across approximately 160 global sites.
Key Findings from the ASSURE Trial
The interim analysis demonstrated that 81% of individuals treated with Livdelzi achieved a composite biochemical response (CBR), indicating significant improvements in markers associated with PBC progression. Furthermore, 41% of participants achieved normalization of alkaline phosphatase (ALP) levels, a critical biomarker of liver function. These data underscore Livdelzi's potential to modify the course of PBC.
The study included adult PBC patients who had an inadequate response or intolerance to ursodeoxycholic acid (UDCA). Data from participants in previous Livdelzi clinical trials, including the pivotal Phase III RESPONSE study, were also incorporated into the analysis.
Safety and Tolerability Profile
Notably, the safety profile of Livdelzi was favorable, with no treatment-related serious adverse events (SAEs) reported. Over time, the incidence of adverse events per 100 patient-years decreased, suggesting good tolerability with up to three years of exposure. An analysis of a prespecified subgroup also highlighted the efficacy and safety of Livdelzi in individuals with PBC and compensated cirrhosis.
Impact on Pruritus
Beyond biochemical markers, a secondary analysis of pruritus (itching) from the RESPONSE study indicated that Livdelzi led to near resolution of itch in a significant proportion of participants, compared to none in the placebo group. This is a particularly important finding, as pruritus is a common and debilitating symptom of PBC.
Additional Safety Data
Gilead also presented findings from a large safety database, demonstrating the therapy’s tolerability over up to five years of treatment across various studies. The exposure-adjusted incidence rates for adverse events were lower for Livdelzi compared to placebo, reinforcing its safety profile.
Expert Commentary
Gilead Sciences Inflammation Therapeutics Clinical Development Vice-President Timothy Watkins stated, "Gilead has a legacy of bringing groundbreaking treatments to people in need, and Livdelzi is the first and only treatment to demonstrate statistically significant and durable improvements in both pruritus and markers of cholestasis related to the risk of disease progression."
He added, "With Livdelzi, we’ve introduced an effective and well-tolerated option for people living with PBC, offering an important novel treatment option. We remain committed to advancing innovative therapies that provide real hope and improved outcomes for people facing this challenging liver disease."
