GlaxoSmithKline (GSK) has reported positive data from the Phase IIb study of its investigational product, linerixibat, to treat cholestatic pruritus in primary biliary cholangitis (PBC), a cholestatic liver disease.
Linerixibat is an oral ileal bile acid transporter (IBAT) inhibitor.
The study ‘GSK2330672 trial of IBAT inhibition with Multidose Measurement for Evaluation of Response’ (GLIMMER) of linerixibat in patients with PBC showed that the drug significantly improved itch or cholestatic pruritus in some treatment groups compared to placebo.
The double-blind, randomised, placebo-controlled, Phase IIb study enrolled a total of 147 patients with cholestatic pruritus associated with PBC.
It assessed dose response and tolerability of linerixibat at doses of 20mg, 90mg, or 180mg once daily, or 40mg or 90mg twice daily, or placebo, for 12 weeks.
GLIMMER is the first study to leverage GSK-23andMe collaboration as a pilot to accelerate clinical trial.
The trial data showed that three linerixibat groups, 40mg and 90mg twice daily and 180mg daily, demonstrated significant improvement in itch over placebo.
A significant difference in itch was achieved in patients with moderate to severe pruritus in the 40mg twice daily group over placebo.
This dose also demonstrated significant improvements from baseline in measures of quality of life.
Safety and tolerability profiles of linerixibat were acceptable to progress to Phase III study in 2021.
GlaxoSmithKline Development senior vice-president Christopher Corsico said: “With no new treatment advances in the last 60 years, these data suggest that linerixibat may provide relief to patients suffering the debilitating impact of cholestatic pruritus associated with primary biliary cholangitis.
“The GLIMMER study also marks the first time we have collaborated with 23andMe to support patient recruitment.”