GSK announces GLISTEN phase III trial met primary, key secondary endpoints

GSK (GSK) announced positive results from the GLISTEN phase III trial evaluating linerixibat, an investigational targeted inhibitor of the ileal bile acid transporter, IBAT, in adults with cholestatic pruritus and PBC, a rare autoimmune liver disease. The full data were presented in a late-breaker oral presentation at the EASL Congress 2025. GLISTEN met the primary endpoint of change from baseline in monthly itch score and showed linerixibat significantly improved itch versus placebo over 24-weeks, as measured on a 0-10 numerical rating scale for the worst itch. Monthly itch score evaluated the worst weekly itch of each month over the 24-week treatment period. This finding supports linerixibat’s potential to address a major symptom of PBC, relentless itch. The trial also met key secondary endpoints including itch score at week 2 and itch-related sleep interference NRS over 24 weeks demonstrating: Improvement in itch was rapid with a significant improvement over placebo at week 2 and sustained throughout the trial. Significant improvement in itch-related sleep interference, which impacts patient quality of life, over 24 weeks of treatment with linerixibat compared with placebo. More patients in the linerixibat group had clinically meaningful itch improvement with 56% versus 43% in the placebo group at week 24.