Policy & Regulation
Chugai Data from Global Phase II Study Confirm Safety and Efficacy of Long Term Nemolizumab in Atopic Dermatitis
15 May 2018 - - Tokyo, Japan-based pharmaceutical company Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) has published long-term data from a global phase II study (the XCIMA study) for nemolizumab (CIM331) in Journal of Allergy and Clinical Immunology Online, the company said.
The study was conducted to evaluate safety and efficacy of long-term administration of nemolizumab in 264 patients with moderate-to-severe atopic dermatitis (AD). It confirmed that nemolizumab maintained its safety and efficacy after one year of continuous treatment.
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. Currently, Galderma is conducting a phase 2b study and Maruho is conducting a phase 3 study.
Nemolizumab (CIM331) is a humanized anti-human IL-31 receptor A (IL-31RA) monoclonal antibody intending to be a first-in-class treatment. IL-31 is identified as a pro-inflammatory cytokine that can induce pruritus, inflammation, and skin barrier dysfunction in atopic dermatitis, as well as pruritus in dialysis patients.
Nemolizumab is thought to work by inhibiting biological activity of IL-31 through competitively blocking the binding of IL-31 to its receptor.
Chugai specialises in prescription pharmaceuticals; it is working to develop innovative products which may satisfy unmet medical needs, mainly focusing on the oncology area.
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