GSK’s linerixibat has shown promising results in a late-stage trial of primary biliary cholangitis (PBC) patients with cholestatic pruritus, or relentless itch.
The phase 3 GLISTEN trial has been evaluating the candidate in adult PBC patients with moderate-to-severe itch who were receiving stable doses of guideline-suggested therapies for pruritus, were treatment naïve, or had been previously treated.
The study met its primary endpoint, with linerixibat demonstrating a statistically significant reduction from baseline in monthly itch score over 24 weeks versus placebo.
The preliminary safety results were also found to be generally consistent with those seen in prior studies of the drug, GSK said, adding that full results of the trial will be presented at a future scientific congress.
Approximately 510,000 people globally will be diagnosed with PBC by 2030. The rare cholestatic liver disease of the bile ducts primarily affects women and can cause liver damage, as well as lead to liver failure if left untreated.
Pruritus, which can occur at any stage of the disease, is experienced by up to 90% of patients and is associated with sleep disturbance, fatigue and impaired quality of life.
“The itch associated with PBC for many patients is unrelenting and often severe but is a symptom that is frequently overlooked or dismissed,” explained Carol Roberts, president of the PBCers Organization. “The potential of a treatment option that addresses a root cause of itch answers a previously unmet need for people with PBC.”
GSK’s linerixibat is designed to address a root cause of cholestatic pruritus by inhibiting bile acid re-uptake and has already been granted orphan drug designations by the US Food and Drug Administration and the European Medicines Agency to treat PBC-associated cholestatic pruritus.
Commenting on the latest results for the candidate, Kaivan Khavandi, senior vice president and global head, respiratory/immunology research and development, GSK, said: “Linerixibat has the potential to be the first global therapy specifically developed to treat itch in PBC.
“This positive data suggests that it could have a place in supporting patients whose quality of life is significantly affected in multiple ways by persistent itching.”