Alkaline phosphatase changes with seladelpar across subgroups of primary biliary cholangitis patients in the response trial

Introduction: Alkaline phosphatase (ALP) is an important marker in primary biliary cholangitis (PBC) associated with risk for disease progression. In the pivotal, Phase 3, placebo-controlled RESPONSE trial (NCT04620733), seladelpar, a first-in-class delpar (selective PPAR-delta agonist), led to a significantly higher percentage of PBC patients (pts) achieving the composite biochemical endpoint (ALP<1.67x upper limit of normal [ULN], ALP decrease≥15%, and total bilirubin [TB]≤ULN) compared to placebo (61.7% vs 20%) and decreased mean ALP levels after one year (-42.4% vs -4.3%, respectively).