GSK plc has announced positive results from its Phase III GLISTEN trial evaluating linerixibat for the treatment of cholestatic pruritus (persistent itching) in patients with primary biliary cholangitis (PBC). The trial achieved its primary endpoint, demonstrating a statistically significant improvement in itch over 24 weeks compared to placebo.
GLISTEN Trial Details
The GLISTEN trial was a double-blind, randomized, placebo-controlled study with a crossover design. It enrolled PBC patients experiencing moderate to severe itch, including those who were treatment-naive, previously treated, or receiving stable doses of guideline-suggested therapies for pruritus. The primary and secondary outcomes were assessed using itch-related measures and quality-of-life questionnaires. Preliminary safety results were consistent with those from prior studies.
Clinical Significance
Kaivan Khavandi, SVP & Global Head of Respiratory/Immunology R&D at GSK, emphasized linerixibat's potential to be the first global therapy specifically developed for PBC-related itch, which could significantly improve patients' quality of life. Up to 90% of individuals with PBC experience cholestatic pruritus, a condition caused by excess bile acids, leading to severe itching that impacts sleep, mental health, and overall well-being. Current treatments often fail to adequately address the severity of this symptom, as PBC has no cure.
Mechanism of Action
Linerixibat is an investigational drug designed to inhibit the ileal bile acid transporter (IBAT), reducing bile acid re-uptake and potentially addressing a root cause of the itch associated with PBC. The drug has been granted Orphan Drug Designation in both the US and EU.
PBC Disease Context
PBC is a rare autoimmune liver disease affecting the liver's bile ducts. This leads to a buildup of bile acids, which are believed to cause cholestatic pruritus. The disease currently has no cure, and existing treatments often fall short of providing adequate relief from the debilitating itch.
