▎WuXiEdited by Kant Content Team
GSK Announces Positive Topline Results from Ongoing Global Phase 3 Trial GLISTEN. The trial evaluated the efficacy of the ileal bile acid transporter (IBAT) inhibitor linerixibat in adult patients with cholestatic pruritus associated with primary biliary cholangitis (PBC), a rare autoimmune liver disease.GLISTEN Trial Met Primary Endpoint: Linerixibat Significantly Improved Pruritus Symptoms Compared to Placebo, Demonstrated by a Significant Reduction in Monthly Itch Score from Baseline Over 24 Weeks.The trial recruited PBC patients with moderate to severe pruritus who were receiving guideline-recommended treatments for pruritus, including both treatment-naïve and previously treated patients. Preliminary safety outcomes were generally consistent with those observed in prior studies. Further analysis of these data is currently underway. Complete results from the GLISTEN trial will be presented at a future scientific conference.It is estimated that by 2030, more than 500,000 people worldwide will be diagnosed with PBC, of which over 240,000 will experience refractory pruritus requiring treatment, reflecting a significant unmet need. In patients with PBC, bile flow in the liver is obstructed. Excessive levels of bile acids in circulation are considered the main cause of cholestatic pruritus, an internal itching that cannot be relieved by scratching. Pruritus can occur at any stage of PBC and may affect up to 90% of PBC patients. Cholestatic pruritus is a serious condition that can lead to sleep disturbances, fatigue, decreased quality of life, and even the need for liver transplantation in the absence of liver failure.Linerixibat is an oral IBAT inhibitor with the potential to treat cholestatic pruritus associated with PBC. By inhibiting the reabsorption of bile acids, linerixibat aims to address the root cause of cholestatic pruritus.The U.S. FDA and the European Medicines Agency (EMA) have granted linerixibat orphan drug designation for the treatment of cholestatic pruritus associated with PBC.
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References:
[1] Linerixibat shows positive Phase III results in cholestatic pruritus (relentless itch) in primary biliary cholangitis (PBC). Retrieved November 19, 2024, from https://www.gsk.com/en-gb/media/press-releases/linerixibat-shows-positive-phase-iii-results-in-cholestatic-pruritus/
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