Japan Tobacco Inc. (JT)(TSE:2914) and Torii Pharmaceutical Co., Ltd. (Torii) (TSE:4551) announced today the top-line results of Phase 3 study in infant patients with atopic dermatitis in Japan for JTE-052 (generic name: delgocitinib) ointment, a Janus kinase (JAK) inhibitor. Delgocitinib ointment has been developed in Japan for patients with atopic dermatitis by JT and Torii under the terms of an agreement for co-development and marketing in Japan, signed in October 2016.
This study is an open-label, uncontrolled study to evaluate the efficacy and safety of delgocitinib ointment 0.25% and 0.5% over 52 weeks in infant patients with atopic dermatitis (aged 6 to <24 months), conducted in Japan. The top-line results as of the 28th week of treatment show the delgocitinib ointment's effect in improving skin eczema. The safety of the ointment within the treatment period was also confirmed. Based on these results and other clinical studies, JT and Torii will aim to submit a manufacturing and marketing application for delgocitinib ointment in Japan.
Torii also distributes delgocitinib ointment under the brand name CORECTIM®in Japan, where CORECTIM®Ointment 0.5% is approved for the treatment of adults and pediatric atopic dermatitis, and CORECTIM®Ointment 0.25% is approved for the treatment of pediatric atopic dermatitis.
ABOUT Atopic Dermatitis
Atopic dermatitis is a chronic and pruritic inflammatory skin disease. It is thought to develop through exposure to various irritation or allergens for patients with a physiological abnormality of the skin (dry skin and abnormal skin barrier function).
Japan Tobacco Inc. is a leading international tobacco company with operations in more than 130 countries. With approximately 58,000 employees, it manufactures and sells some of the world's best-known brands including Winston, Camel, MEVIUS and LD. The JT Group is committed to investing in Reduced-Risk Products (RRP) and currently markets its heated tobacco products under the Ploom brand and various e-cigarette products under its Logic brand. The Group is also present in the pharmaceutical and processed food businesses.
Japan Tobacco Inc. published this content on 14 December 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 14 December 2021 06:07:06 UTC.