Gilead Announces Long-term Safety And Efficacy Data For Seladelpar In Primary Biliary Cholangitis

(RTTNews) - Gilead Sciences, Inc. (GILD) Wednesday announced positive results from two-year interim analysis of the ongoing ASSURE study evaluating the company's investigational drug seladelpar for the treatment of primary biliary cholangitis (PBC), a rare, chronic inflammatory liver disease.

The two-year interim analysis included patients who participated in any prior clinical studies of seladelpar (legacy studies) and participants from the pivotal Phase 3 RESPONSE study. The positive results from the two-year interim analysis were highly consistent with one-year interim analysis.

Results from the study showed rapid and sustained improvements in markers of cholestasis, including high rates of normalization of liver biomarkers and a clinically meaningful reduction in pruritus in patients treated with seladelpar.

These data were shared in a presentation during the European Association for the Study of the Liver (EASL) Congress 2024 in Milan, Italy.