GSK's Investigational Liver Disease Candidate Hits Primary Goal In Late-Stage Study To Treat Relentless Itch In Some Patients

On Tuesday, GSK plc GSK released the headline results of the GLISTEN global phase 3 trial evaluating linerixibat 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 improving itch, as demonstrated by a statistically significant reduction from baseline in monthly itch score over 24 weeks versus placebo.

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The trial recruited 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 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.”

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.

The full results of GLISTEN will be presented at a future scientific congress.

Investigational Linerixibat has been granted Orphan Drug Designation in the U.S. and EU.

In August this year, GSK requested a timeline adjustment, so the appraisal is expected to start in late September 2025. Submissions will be due around late November 2025.

This change allows the company more time to prepare a thorough and detailed submission for the National Institute for Health and Care Excellence (NICE).

Price Action: GSK stock is down 0.56% at $33.50 at the last check on Tuesday.

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