Chugai Pharmaceutical Co., Ltd. has announced that the data from the global phase II study (the XCIMA study) for the planned indication of atopic dermatitis (AD) was published in The New England Journal of Medicine Online on March 2, 2017 (EST). The study was conducted to evaluate the safety and efficacy of nemolizumab in 264 patients with moderate-to-severe AD, and the safety and efficacy of nemolizumab at 12 weeks were confirmed.

The efficacy and safety data obtained from a one-year extension of the study will be presented on March 4 at the Late-Breaking Research Forums of the 2017 Annual American Academy of Dermatology (AAD) Meeting which will be held on March 3 to 7 in Orlando, Florida, USA.

“Control of pruritus is crucial for AD patients. It is directly related to their quality of life,” said Dr Yasushi Ito, senior vice president, head of project & lifecycle management unit. “This data emphasizes the importance of controlling IL-31 in AD. It also indicates that nemolizumab, an anti-IL-31 antibody, may offer a promising treatment option for the disease. Chugai will closely work together with its partners - Galderma and Maruho, toward helping AD patients by offering this new treatment option as early as possible.”

“Nemolizumab is the first drug specifically targeting pruritus. Its use is very convenient to patients with one subcutaneous injection per month,” said, Professor Thomas Ruzicka, Ludwig-Maximilian University Munich, the first author of the article. “Since IL-31 is involved in a variety of other pruritic skin diseases, the innovative drug has a large potential in dermatology.”

Chugai granted the exclusive development and marketing rights of nemolizumab worldwide, excluding Japan and Taiwan to Galderma and licensed out the development and marketing rights in the skin disease area to Maruho for the Japanese market respectively.