GSK's IBAT inhibitor treatment for PBC-related pruritus in phase III trial succeeds
On November 19, GSK (US) announced positive results from the Phase III GLISTEN study, which was designed to evaluate the efficacy and safety of Linerixibat, an inhibitor of the ileal bile acid transporter (IBAT), in treating pruritus associated with primary biliary cholangitis (PBC, a rare autoimmune liver disease) in adult patients. PBC is a rare bile duct disease that mainly affects women and, if left untreated, can lead to liver damage or even liver failure. One of its most common symptoms is a persistent, intolerable itch, which is often exacerbated by fatigue, especially at night. Currently, there is no cure for this disease. By 2030, there will be 510,000 patients worldwide diagnosed with PBC, of whom more than 24,000 will suffer from intolerable itch symptoms that require treatment, representing a significant unmet medical need. The current guidelines-recommended therapies for pruritus associated with bile stasis are not sufficient, with limited relief of itch and poor tolerability. Linerixibat is an oral IBAT inhibitor that aims to address the root cause of bile stasis pruritus by inhibiting bile acid reuptake.