Gilead's Seladelpar Shows Major Liver Disease Progression Improvement, Itch Reduction In PBC Study

(RTTNews) - Gilead Sciences Inc. (GILD) announced interim results from the ongoing ASSURE study demonstrating treatment with seladelpar, an investigational PPAR delta agonist, led to improvements in markers of cholestasis and reduced inflammation.

Additional findings demonstrate that seladelpar can help reduce pruritus (itch) in people living with primary biliary cholangitis or PBC. There are currently no treatments indicated to treat primary biliary cholangitis-related pruritis.

The company noted that the interim data analysis did not include patients from the Phase 3 RESPONSE study, which will be reported separately. Of the 174 patients included, the majority had a gap of one year or more between completion of the respective primary study (seladelpar or placebo) and enrollment into ASSURE. Enrolled patients received an open-label oral dose of 10 mg seladelpar once daily, with the majority (97%) also receiving ursodeoxycholic acid or UDCA treatment.

Seventy percent of the 148 patients receiving Seladelpar 10mg achieved the clinically meaningful composite response endpoint. Among those receiving seladelpar, 37% experienced alkaline phosphatase or ALP normalization, with a mean ALP change from baseline of -44%. The patients completed 12 months of treatment.

Seladelpar also reduced other important biomarkers of liver injury including TB, gamma-glutamyl transferase (GGT) and alanine aminotransferase (ALT) levels by 9%, 36%, and 25% from baseline, respectively. There were no treatment-related serious adverse events in the study, as determined by the study investigators. Seladelpar was generally well tolerated, with discontinuation due to adverse events occurring in 4.6% of patients.

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