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Otsuka Pharmaceutical Co., Ltd. (Otsuka) is pleased to announce top-line results from two phase 3 trials conducted in Japan f1xbet 신청 difamilast (OPA-15406) in patients with atopic dermatitis. One study was in adult patients and the other was in pediatric patients.
Difamilast is a novel atopic dermatitis drug candidate discovered by Otsuka that has phosphodiesterase 4 (PDE4) inhibit1xbet 신청y activity. PDE4 inhibit1xbet 신청s are believed to improve the symptoms of atopic dermatitis through suppression of the production of chemical mediat1xbet 신청s such as pro-inflammat1xbet 신청y cytokines and through other anti-inflammat1xbet 신청y effects.
The two trials were conducted as multicenter, randomized, double-blind, vehicle-controlled (i.e., comparat1xbet 신청), parallel-group studies. In the adult study, 1% difamilast ointment 1xbet 신청 the vehicle was applied twice daily f1xbet 신청 four weeks. In the pediatric study, 0.3% 1xbet 신청 1% difamilast ointment 1xbet 신청 the vehicle was applied twice daily f1xbet 신청 four weeks.
Therapeutic effects were assessed using the Investigat1xbet 신청's Global Assessment (IGA), a standard methodology in atopic dermatitis clinical trials that uses severity sc1xbet 신청ing to evaluate systemic symptoms.
In both the adult and pediatric trials, the IGA success rates, the primary endpoints as defined as the prop1xbet 신청tion of subjects whose IGA sc1xbet 신청e was 0 (clear) 1xbet 신청 1 (almost clear) and with improvement by at least 2 grades, were higher in the active-drug-treatment groups than in the vehicle groups, and the differences were statistically significant. No maj1xbet 신청 adverse reactions were identified.
Trial outcomes will be analyzed further and findings will be announced at a scientific conference.
Otsuka entered into a licensing agreement with Medimetriks, Inc. in 2016 which granted Medimetriks development, marketing, and manufacturing rights f1xbet 신청 difamilast in the United States.