Gilead Sciences Inc. (GILD) has released findings from a two-and-a-half-year interim analysis of the ongoing Phase 3 ASSURE study. The results indicate that 81% of participants with primary biliary cholangitis (PBC) treated with Livdelzi (seladelpar) achieved a composite biochemical response (CBR), highlighting significant improvements in critical measures of PBC progression. Notably, 41% of participants reached normalization of alkaline phosphatase (ALP) levels, a crucial biomarker for liver function.
The interim analysis, which utilized a data cutoff of January 31, 2024, encompassed all participants in the ASSURE study, including those from previous clinical trials of Livdelzi (legacy studies) and participants from the pivotal Phase 3 RESPONSE study. The study attests to the robust safety profile of Livdelzi, with no treatment-related serious adverse events (SAEs) reported throughout its duration. The exposure-adjusted incidence of adverse events diminished over time, with observed rates of 86, 70, and 63 participants per 100 patient-years in the first, second, and third years of treatment, respectively.
Gilead emphasized that Livdelzi continues to be generally well tolerated, with no new safety concerns or changes in the frequency of adverse events over a treatment span of up to three years. These findings are in line with the results previously presented at the European Association for the Study of the Liver (EASL) Congress earlier this year.