Chugai Pharmaceutical Co., Ltd. announced that the long-term data from a global phase II study (the XCIMA study) for nemolisumab (CIM331) was published in Journal of Allergy and Clinical Immunology Online on May 9, 2018.“Nemolisumab in moderate-to-severe atopic dermatitis: Randomised, phase II, long-term extension study” Kenji Kabashima, M.D., Ph.D.,“Control of chronic pruritus and inflammation of the skin is crucial for patients with atopic dermatitis (AD). This long-term extension data which demonstrated efficacy and safety of nemolisumab reinforced anticipation that nemolisumab may offer a novel treatment option for the disease,” said Dr. Yasushi Ito, executive vice president, co-head of project & lifecycle Management Unit. “Chugai’s mission is to contribute to patients through innovative medicines. We will closely work together with our partners - Galderma and Maruho, towards helping AD patients by developing this new treatment option as quickly as possible.”
“I am delighted to see a steady development of the novel treatment which addresses pathogenesis of pruritus in atopic dermatitis,” said, Professor Kenji Kabashima, Kyoto University, the first author of the article. “I would like to carefully examine safety and efficacy of nemolisumab further, in the expectation of future clinical use.”
The study was conducted to evaluate safety and efficacy of nemolisumab in 264 patients with moderate-to-severe AD. The safety and efficacy of nemolisumab at 12 weeks, the study’s primary endpoint, were confirmed and published in The New England Journal of Medicine Online in March 2017. The data published this time was obtained to assess safety and efficacy of long-term administration. It confirmed that nemolisumab maintained its safety and efficacy after one year of continuous treatment.