GSK (GSK) said Thursday that its phase 3 trial evaluating linerixibat as potential treatment for cholestatic pruritus, or relentless itch, in primary biliary cholangitis patients met the primary and key secondary endpoints.
The company said the trial met the primary endpoint of change from baseline in monthly itch score, with linerixibat significantly improving itch versus placebo over a 24-week period.
The trial also met key secondary endpoints, including "significant" improvements in itch score at week two and itch-related sleep interference over 24 weeks compared with placebo.
GSK also said the investigational drug's safety profile was consistent with data from previous studies.
GSK said linerixibat was granted orphan drug designation in cholestatic pruritus in PBC by the US Food and Drug Administration and European Medicines Agency.
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