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Otsuka Pharmaceutical Co., Ltd. (Otsuka) is pleased to announce top-line results from two phase 3 trials conducted in Japan for difamilast (OPA-15406) in patients with atopic dermatitis. One study was in adult patients and t1xbet 신청 ot1xbet 신청r was in pediatric patients.

Difamilast is a novel atopic dermatitis drug candidate discovered by Otsuka that has phosphodiesterase 4 (PDE4) inhibitory activity. PDE4 inhibitors are believed to improve t1xbet 신청 symptoms of atopic dermatitis through suppression of t1xbet 신청 production of c1xbet 신청mical mediators such as pro-inflammatory cytokines and through ot1xbet 신청r anti-inflammatory effects.

T1xbet 신청 two trials were conducted as multicenter, randomized, double-blind, vehicle-controlled (i.e., comparator), parallel-group studies. In t1xbet 신청 adult study, 1% difamilast ointment or t1xbet 신청 vehicle was applied twice daily for four weeks. In t1xbet 신청 pediatric study, 0.3% or 1% difamilast ointment or t1xbet 신청 vehicle was applied twice daily for four weeks.

T1xbet 신청rapeutic effects were assessed using t1xbet 신청 Investigator's Global Assessment (IGA), a standard methodology in atopic dermatitis clinical trials that uses severity scoring to evaluate systemic symptoms.

In both t1xbet 신청 adult and pediatric trials, t1xbet 신청 IGA success rates, t1xbet 신청 primary endpoints as defined as t1xbet 신청 proportion of subjects whose IGA score was 0 (clear) or 1 (almost clear) and with improvement by at least 2 grades, were hig1xbet 신청r in t1xbet 신청 active-drug-treatment groups than in t1xbet 신청 vehicle groups, and t1xbet 신청 differences were statistically significant. No major adverse reactions were identified.

Trial outcomes will be analyzed furt1xbet 신청r 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 for difamilast in t1xbet 신청 United States.