UK-based pharmaceutical giant GlaxoSmithKline (GSK; NYSE: GSK) has announced positive headline results from the Phase III GLISTEN study, which assessed the efficacy of its ileal bile acid transporter (IBAT) inhibitor, linerixibat, in treating cholestatic pruritus (relentless itch) associated with primary biliary cholangitis (PBC).
Study Design and Primary Endpoint Achievement
The GLISTEN study was designed to evaluate the efficacy of linerixibat in adult patients suffering from PBC-associated cholestatic pruritus. The study successfully met its primary endpoint, with data indicating that linerixibat resulted in a statistically significant reduction from baseline in monthly itch scores over a 24-week period compared to placebo. This significant improvement suggests that linerixibat could offer a meaningful therapeutic option for patients dealing with the persistent itch associated with PBC.
Safety Profile Consistent with Previous Findings
Furthermore, the safety profile of linerixibat, as observed in the GLISTEN study, was found to be consistent with previous findings. This consistency in safety data is an important factor in the drug’s potential for regulatory approval and subsequent use in clinical settings.-Fineline Info & Tech
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