GSK today announced positive headline results of GLISTEN, the ongoing global phase III clinical trial evaluating linerixibat, an investigational targeted inhibitor of the ileal bile acid transporter (IBAT), in adults with cholestatic pruritus (relentless itch) associated with primary biliary cholangitis (PBC), a rare autoimmune liver disease.
GLISTEN met its primary endpoint, with linerixibat resulting in an improvement in itch, as demonstrated by a statistically significant reduction from baseline in monthly itch score over 24 weeks versus placebo. The trial recruited PBC patients with moderate to severe itch, who were receiving stable doses of guideline-suggested therapies for pruritus, or were treatment naïve, or had been previously treated. The preliminary safety results are generally consistent with those seen in prior studies of linerixibat. Further analysis of these data is ongoing.
Kaivan Khavandi, SVP & Global Head, Respiratory/Immunology R&D, GSK, said: “Linerixibat has the potential to be the first global therapy specifically developed to treat itch in PBC. These positive data suggest that it could have a place in supporting patients whose quality of life is significantly affected in multiple ways by persistent itching.”
People who have been diagnosed with PBC will reach 510,000 globally by 2030, and more than 240,000 people will experience relentless itch requiring treatment, representing a significant unmet need. Current guideline suggested therapies available for cholestatic pruritus are inadequate, with known limited impact on itch, and poor tolerability. PBC is a rare disease of the bile ducts that primarily affects women and can cause liver damage and possible liver failure if untreated. One of the most common symptoms is constant, relentless itching or skin-crawling sensations, as well as fatigue that is often made worse by itching at night. The disease currently has no cure.
Carol Roberts, President, The PBCers Organization, said: “The itch associated with PBC for many patients is unrelenting and often severe but is a symptom that is frequently overlooked or dismissed. It has a significant impact on quality of life and mental health for people with PBC. The potential of a treatment option that addresses a root cause of itch answers a previously unmet need for people with PBC.”
