Maruho says late-stage trial of experimental drug nemolizumab in pruritus hits main goal

Maruho announced Thursday that a Phase III study investigating the experimental drug nemolizumab for the treatment of pruritus associated with atopic dermatitis met its primary endpoint. Results showed that patients treated with the anti-IL-31 receptor A humanised monoclonal antibody had significant improvements versus placebo in the change rate of pruritus visual analogue scale 16 weeks after administration.

The study, which was conducted in Japan, included 215 subjects over 13 years of age with atopic dermatitis who had moderate-to-severe pruritus. Along with the main goal, nemolizumab demonstrated significant improvements compared to placebo in the rate of change in the eczema area and severity index (EASI) 16 weeks after administration, a secondary endpoint of the trial. Maruho added that the drug was well tolerated in the study.

Maruho plans to seek approval of nemolizumab in Japan based on the results of the trial and other ongoing studies. The company licensed Japanese rights to nemolizumab from Chugai Pharmaceutical in 2016, while Galderma has rights in the rest of the world, excluding Taiwan.

Galderma is preparing to start a pivotal Phase III programme for nemolizumab in moderate-to-severe atopic dermatitis by mid-2019 having reported last month that a Phase IIb study of the drug met its primary endpoint of a greater improvement in EASI versus placebo. Results showed that a 73-percent reduction in mean EASI score was observed at week 24 with nemolizumab compared with 58 percent for placebo.

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