Clinical Trials

Global biopharma company GSK has announced positive phase 3 results for its cholestatic pruritus (relentless itch) in primary biliary cholangitis (PBC) treatment, linerixibat, which is currently being studied in the GLISTEN trial.

Cholestatic pruritus is an internal itch experienced by people with PBC, a rare disease of the bile ducts where bile flow to the liver is disrupted, causing liver damage and, potentially, liver failure. Cholestatic pruritus causes sleep disturbance, fatigue, impaired quality of life and, in some cases, the need for a liver transplant in the absence of live failure. Linerixibat is an ileal bile acid transporter (IBAT) inhibitor, aiming to treat cholestatic pruritus at its root.

GLISTEN, an ongoing doubleblind, randomised, placebo-controlled phase 3 trial, met its primary endpoint of a statistically significant reduction from baseline in monthly itch score over 24 weeks versus placebo.

Kaivan Khavandi, SVP & global head of Respiratory Immunology R&D at GSK, said, “Linerixibat has the potential to be the first global therapy specifically developed to treat itch in PBC. This positive data suggests that it could have a place in supporting patients whose quality of life is significantly affected in multiple ways by persistent itching.”