Gilead's Livdelzi Shows Sustained Efficacy, Long-Term Safety In PBC Management

(RTTNews) - Gilead Sciences Inc. (GILD) announced data from a two-and-a-half-year interim analysis from the ongoing Phase 3 ASSURE study, which showed that 81% of participants with primary biliary cholangitis or PBC treated with Livdelzi (seladelpar) achieved a composite biochemical response or CBR, demonstrating significant improvements in a key measures of PBC progression. Additionally, 41% of participants achieved normalization of alkaline phosphatase or ALP levels, a critical biomarker of liver function.

Using a data cutoff of January 31, 2024, the interim analysis represented all participants in the ASSURE study, including those who participated in prior clinical studies of Livdelzi (legacy studies) and participants from the pivotal Phase 3 RESPONSE study. Results demonstrate the safety profile of Livdelzi remains robust, with no treatment-related serious adverse events (SAEs) reported throughout the study duration. The exposure-adjusted incidence of adverse events decreased over time, with 86, 70, and 63 participants per 100 patient-years observed in years 1, 2 and 3 of treatment, respectively.

The company noted that Livdelzi continues to appear generally well tolerated, with no new safety signals or change in frequency of adverse events (AEs) with up to three years of exposure. The results are consistent with the results presented at the European Association for the Study of the Liver (EASL) Congress earlier this year.

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