Gilead Sciences Inc. (GILD) has reported interim results from the ongoing ASSURE study, which indicate that treatment with seladelpar, an investigational PPAR delta agonist, has led to improvements in cholestasis markers and reduced inflammation.
The study also revealed that seladelpar may alleviate pruritus (itch) in individuals with primary biliary cholangitis (PBC), a condition for which no current treatments are specifically indicated.
The company clarified that the interim data analysis did not incorporate patients from the Phase 3 RESPONSE study, which will be detailed separately. Among the 174 patients included in ASSURE, most had a gap of one year or more between completing the primary study (whether seladelpar or placebo) and enrolling in ASSURE. Participants received an open-label oral dose of 10 mg seladelpar once daily, with 97% also receiving ursodeoxycholic acid (UDCA).
Of the 148 patients treated with Seladelpar 10mg, 70% met the clinically meaningful composite response endpoint. Among these, 37% achieved normalization in alkaline phosphatase (ALP) levels, with a mean ALP reduction of -44% from baseline after 12 months of treatment.
Seladelpar further reduced other critical liver injury biomarkers: total bilirubin (TB) by 9%, gamma-glutamyl transferase (GGT) by 36%, and alanine aminotransferase (ALT) by 25% from baseline. Study investigators reported no treatment-related serious adverse events. Seladelpar was generally well tolerated, with a 4.6% incidence of patient discontinuation due to adverse events.
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