On November 19, GlaxoSmithKline (GSK.US) announced that the Phase III GLISTEN study had achieved positive results.
According to the Wise News Finance app, on November 19, GlaxoSmithKline (GSK.US) announced that the Phase III GLISTEN study had achieved positive results. The study aimed to evaluate the efficacy and safety of the ileal bile acid transporter (IBAT) inhibitor Linerixibat in treating pruritus associated with primary biliary cholangitis (PBC, a rare autoimmune liver disease) in adult patients with cholestatic itch (chronic itch).
PBC is a rare biliary tract disease that mainly affects women. Without treatment, it may lead to liver damage or even liver failure. One of its most common symptoms is persistent and unbearable itching as well as fatigue, with nocturnal itch often worsening fatigue. Currently, there is no cure for this disease. By 2030, the number of diagnosed PBC patients globally will reach 0.51 million cases, with over 0.24 million individuals suffering from intolerable itching symptoms requiring treatment, indicating a significant unmet medical need. The currently recommended therapies for cholestatic pruritus in guidelines are inadequate, with limited itch relief and poor tolerability.
Linerixibat is an oral IBAT inhibitor aimed at fundamentally addressing cholestatic pruritus by inhibiting the reuptake of bile acids.