ASSURE Study Overview

ASSURE: An open-label, long-term extension study1

ASSURE is an ongoing, open-label, long-term extension study to evaluate the safety and efficacy of LIVDELZI. Patients from both arms of the pivotal study, RESPONSE, or who participated in a prior LIVDELZI primary biliary cholangitis (PBC) clinical study were invited to participate. Interim 2-year efficacy and safety results through January 31, 2024, have been reported.1,2

Diagram depicting the study design of the ASSURE trial. ASSURE is an ongoing, phase 3 open-­label study including 337 participants from legacy studies and the RESPONSE Pivotal Study.Diagram depicting the study design of the ASSURE trial. ASSURE is an ongoing, phase 3 open-­label study including 337 participants from legacy studies and the RESPONSE Pivotal Study.

ALT=alanine aminotransferase; AST=aspartate aminotransferase; eGFR=estimated glomerular filtration rate; MELD=Model for End-Stage Liver Disease; TB=total bilirubin; ULN=upper limit of normal.

Exclusion criteria are only applicable when patients have a study drug interruption of >4 weeks prior to day 1 and for patients who participated in CB8025-21838.2

†Legacy seladelpar studies include Dose Ranging Phase 2 (NCT02955602), Phase 3 Long-Term Safety Study (NCT03301506), Phase 3 ENHANCE (NCT03602560), and Phase 1b Hepatic Impairment (NCT04950764). Most patients from legacy studies had a treatment gap between their initial use of LIVDELZI and entering the ASSURE study.1,2

‡Patients from the placebo arm of the RESPONSE Pivotal Study switched to active treatment with LIVDELZI in the ASSURE study. This is referred to as the “rollover” arm of ASSURE.2

§54 patients rolled over from the RESPONSE placebo arm and 104 patients rolled over from the RESPONSE LIVDELZI 10 mg arm.1

References: 1. Trivedi PJ, Levy C, Kowdley Kris V, et al. Long-term efficacy and safety of open-label seladelpar treatment in patients with primary biliary cholangitis (PBC): interim results for 2 years from the ASSURE study. Poster presented at: European Association for the Study of the Liver Congress; June 5-8, 2024; Milan, Italy. 2. Yimam K, Levy C, Kowdley KV, et al. ASSURE study in progress: an open-label long-term extension study to evaluate the safety and tolerability of seladelpar in subjects with primary biliary cholangitis (PBC). Poster presented at: Liver Connect Conference; April 4-6, 2024; Scottsdale, AZ.