On November 19, GlaxoSmithKline (GSK.US) announced the positive results of the Phase III GLISTEN study.
The Zhitong Finance App learned that 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 ileo-bile acid transport protein (IBAT) inhibitor Linerixibat in adult patients with cholestatic pruritus (persistent pruritus) associated with primary biliary cholangitis (PBC, a rare autoimmune liver disease).
PBC is a rare biliary disease that mainly affects women and can cause liver damage or even liver failure if left untreated. One of the most common symptoms is constant, unbearable itching and fatigue, which often intensifies the feeling of fatigue at night. Currently, there is no cure for this disease. By 2030, 0.51 million cases of PBC will be diagnosed globally, and more than 0.24 million of them will suffer from unbearable itching and will need treatment, which means there is a huge unmet need for medical treatment. The treatments recommended in current guidelines for cholestatic pruritus are inadequate, have limited relief for itching, and are poorly tolerated.
Linerixibat is an oral IBAT inhibitor designed to fundamentally address cholestatic itching by inhibiting bile acid reuptake.