On Tuesday, GSK plc GSK launched the headline outcomes of the GLISTEN international section 3 trial evaluating linerixibat in adults with cholestatic pruritus (relentless itch) related to major biliary cholangitis (PBC), a uncommon autoimmune liver illness.
GLISTEN met its major endpoint, with linerixibat bettering itch, as demonstrated by a statistically vital discount from baseline in month-to-month itch rating over 24 weeks versus placebo.
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The trial recruited PBC sufferers with reasonable to extreme itch who had been receiving secure doses of guideline-suggested therapies for pruritus, had been therapy naïve, or had been beforehand handled.
The preliminary security outcomes are usually in step with these seen in prior research of linerixibat. Additional evaluation of those information is ongoing.
Kaivan Khavandi, SVP & International Head, Respiratory/Immunology R&D, GSK, stated: “Linerixibat has the potential to be the primary international remedy particularly developed to deal with itch in PBC.”
Individuals who have been identified with PBC will attain 510,000 globally by 2030, and greater than 240,000 individuals will expertise relentless itch requiring therapy.
The complete outcomes of GLISTEN shall be offered at a future scientific congress.
Investigational Linerixibat has been granted Orphan Drug Designation within the U.S. and EU.
In August this yr, GSK requested a timeline adjustment, so the appraisal is predicted to begin in late September 2025. Submissions shall be due round late November 2025.
This alteration permits the corporate extra time to organize a radical and detailed submission for the Nationwide Institute for Well being and Care Excellence (NICE).
Value Motion: GSK inventory is down 0.56% at $33.50 on the final examine on Tuesday.
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