GlaxoSmithKline plc Sponsored ADR (GSK.US) IBAT inhibitor successfully treats PBC-related bile accumulation related itching Phase III study.

On November 19th, GlaxoSmithKline plc Sponsored ADR (GSK.US) announced positive results from the Phase III GLISTEN study. The study aimed to evaluate the efficacy and safety of the ileal bile acid transporter (IBAT) inhibitor Linerixibat in treating cholestatic pruritus (persistent itching) in adults with primary biliary cholangitis (PBC), a rare autoimmune liver disease. PBC is a rare biliary tract disease that mainly affects women and if left untreated, can lead to liver damage and even liver failure. One of its most common symptoms is persistent, unbearable itching and fatigue, with nighttime itching often exacerbating fatigue. Currently, there is no cure for the disease. By 2030, there will be an estimated 510,000 diagnosed PBC patients worldwide, with over 240,000 experiencing unbearable itching symptoms requiring treatment, indicating a significant unmet medical need. Current therapies recommended in guidelines for cholestatic pruritus are not sufficient, providing limited relief and poor tolerability. Linerixibat is an oral IBAT inhibitor that aims to address cholestatic pruritus at its root by inhibiting the reabsorption of bile acids.