GSK announces phase III trial of linerixibat met primary endpoint

GSK (GSK) announced headline results of GLISTEN, the ongoing global phase III clinical trial evaluating linerixibat, an investigational targeted inhibitor of the ileal bile acid transporter, IBAT, in adults with cholestatic pruritus associated with primary biliary cholangitis, 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 naive, 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. The full results of GLISTEN will be presented at a future scientific congress. Linerixibat is currently not approved anywhere in the world; it has been granted Orphan Drug Designation in both the US and EU.