Nemolizumab Achieves Primary Endpoint in Phase 3 Clinical Study (Comparative Study) in Japan for the Treatment of Atopic Dermatitis
Osaka (Japan), April 18, 2019 - Maruho Co., Ltd. ("Maruho", Head Office: Osaka, Japan, President and CEO: Koichi Takagi) announces that a phase 3 clinical study (comparative study) of nemolizumab conducted in Japan for the treatment of pruritus associated with atopic dermatitis (hereinafter referred to as "the study") has achieved its primary endpoint.
The study included 215 subjects over 13 years of age with atopic dermatitis who had moderate to severe pruritus, and compared the efficacy and safety of nemolizumab with placebo 16 weeks after administration. The nemolizumab-treated subjects showed statistically significant improvements compared with the placebo group at the primary endpoint, the change rate of Pruritus VAS 16 weeks after administration, and at the secondary endpoint, the rate of change in EASI 16 weeks after administration. Also, nemolizumab was found to be well-tolerable in this study.
In the future, Maruho aims to apply for marketing approval in Japan, including the results of other clinical trials currently being conducted.
As a pharmaceutical company specializing in dermatology, Maruho hopes to further contribute to patients suffering from itching from atopic dermatitis through the development of nemolizumab.