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LONDON - GSK plc (LSE/NYSE:GSK) has announced successful results from the GLISTEN phase III trial for linerixibat, a treatment aimed at relieving cholestatic pruritus in patients with primary biliary cholangitis (PBC), a rare autoimmune liver disease. The findings, presented at the European Association for the Study of the Liver (EASL) Congress 2025, highlighted that linerixibat met its primary and key secondary endpoints, showing a significant improvement in itch and sleep interference compared to placebo.
The study involved 238 patients, equally divided into linerixibat and placebo groups. Over a 24-week period, linerixibat demonstrated a notable reduction in the monthly itch score, with a significant difference from placebo as early as week two. The treatment also led to better sleep quality due to less itch-related disturbance.
GSK’s linerixibat, an ileal bile acid transporter (IBAT) inhibitor, is specifically designed to reduce bile acids in circulation, which are believed to cause the relentless internal itch experienced by PBC patients. This symptom can severely affect patients’ sleep, mental health, and overall quality of life. Despite 70% of PBC patients having controlled disease with first-line treatment, pruritus often remains unaddressed.
The safety profile of linerixibat aligned with expectations, with gastrointestinal side effects being more common in the treatment group. Diarrhea was the most frequent adverse event but was predominantly mild, leading to a 4% discontinuation rate in the linerixibat group compared to less than 1% in the placebo group.
Kaivan Khavandi, SVP at GSK, emphasized the importance of addressing the high unmet need for treating pruritus and its associated sleep interference in PBC patients. The trial’s lead author, Gideon Hirschfield, also recognized the significance of these improvements, considering the limited options currently available for pruritus in PBC.
While linerixibat is not yet approved for use, it has received orphan drug designation from the US Food and Drug Administration and the European Medicines Agency for the treatment of cholestatic pruritus in PBC patients. The results from the GLISTEN trial represent a potential step forward for those suffering from this debilitating condition.
This report is based on a press release statement and aims to provide an unbiased overview of the GLISTEN trial’s outcomes.
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