ASSURE Long-Term Results

Observed biochemical response at 2 years1

Bar chart entitled “Composite Response” conveying the percentage of patients achieving the composite biochemical endpoint on a month-­by-month basis in the 2-­year interim analysis of the ASSURE trial. Treatment arms depicted include the placebo ± UDCA arm, the LIVDELZI ± UDCA arm, and patients who crossed over from placebo to LIVDELZI. Subpopulations include patients who rolled over from the RESPONSE trial, and patients from legacy studies.Bar chart entitled “Composite Response” conveying the percentage of patients achieving the composite biochemical endpoint on a month-­by-month basis in the 2-­year interim analysis of the ASSURE trial. Treatment arms depicted include the placebo ± UDCA arm, the LIVDELZI ± UDCA arm, and patients who crossed over from placebo to LIVDELZI. Subpopulations include patients who rolled over from the RESPONSE trial, and patients from legacy studies.

~7 out of 10 patients

72% (n=21/29) of patients continuing from the LIVDELZI arm of the RESPONSE study achieved the composite biochemical response at month 241

~9 out of 10 patients

94% (n=15/16) of patients who crossed over from the placebo arm of the RESPONSE study to receive LIVDELZI achieved the composite biochemical response at month 241

70% (n=69/99) of patients in the legacy arm achieved the composite biochemical response at month 241

Alkaline phosphatase (ALP) normalization1

Bar chart entitled “ALP Normalization” conveying the percentage of patients achieving the composite biochemical endpoint on a month-by-month basis in the 2-year interim analysis of the ASSURE trial. Treatment arms depicted include the placebo ± UDCA arm, the LIVDELZI ± UDCA arm, and patients who crossed over from placebo to LIVDELZI. Subpopulations include patients who rolled over from the RESPONSE trial, and patients from legacy studies.Bar chart entitled “ALP Normalization” conveying the percentage of patients achieving the composite biochemical endpoint on a month-by-month basis in the 2-year interim analysis of the ASSURE trial. Treatment arms depicted include the placebo ± UDCA arm, the LIVDELZI ± UDCA arm, and patients who crossed over from placebo to LIVDELZI. Subpopulations include patients who rolled over from the RESPONSE trial, and patients from legacy studies.

~2 out of 10 patients

17% (n=5/29) of patients continuing from the LIVDELZI arm of the RESPONSE study achieved ALP normalization by month 241

5 out of 10 patients

50% (n=8/16) of patients who crossed over from the placebo arm of the RESPONSE study to receive LIVDELZI achieved ALP normalization by month 241

42% (n=42/99) of patients in the legacy arm achieved ALP normalization at month 241

Reference: 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.