Linerixibat shows positive Phase III results in PBC, says GSK

UK pharma major GSK (LSE: GSK) today announced positive headline results of GLISTEN, the ongoing global Phase III clinical trial evaluating linerixibat.

The investigational drug is a targeted inhibitor of the ileal bile acid transporter (IBAT), in adults with cholestatic pruritus (relentless itch) associated with primary biliary cholangitis (PBC), a rare autoimmune liver disease.

GLISTEN met its primary endpoint, with linerixibat resulting in an improvement in itch, as demonstrated by a statistically significant reduction from baseline in monthly itch score over 24 weeks versus placebo. The trial recruited PBC patients with moderate to severe itch, who were receiving stable doses of guideline-suggested therapies for pruritus, or were treatment naïve, or had been previously treated. The preliminary safety results are generally consistent with those seen in prior studies of linerixibat. Further analysis of these data is ongoing.