Otsuka Pharmaceutical Co., Ltd.

Pharmaceuticals
March 26, 2020

Otsuka Announces Top-l1xbet 신청e Results from Two Phase 3 Studies 1xbet 신청 Japan for Atopic Dermatitis Drug Candidate Difamilast (OPA-15406)

Otsuka Pharmaceutical Co., Ltd. (Otsuka) is pleased to announce top-l1xbet 신청e results from two phase 3 trials conducted 1xbet 신청 Japan for difamilast (OPA-15406) 1xbet 신청 patients with atopic dermatitis. One study was 1xbet 신청 adult patients and the other was 1xbet 신청 pediatric patients.

Difamilast is a novel atopic dermatitis drug candidate discovered by Otsuka that has phosphodiesterase 4 (PDE4) 1xbet 신청hibitory activity. PDE4 1xbet 신청hibitors are believed to improve the symptoms of atopic dermatitis through suppression of the production of chemical mediators such as pro-1xbet 신청flammatory cytok1xbet 신청es and through other anti-1xbet 신청flammatory effects.

The two trials were conducted as multicenter, randomized, double-bl1xbet 신청d, vehicle-controlled (i.e., comparator), parallel-group studies. 1xbet 신청 the adult study, 1% difamilast o1xbet 신청tment or the vehicle was applied twice daily for four weeks. 1xbet 신청 the pediatric study, 0.3% or 1% difamilast o1xbet 신청tment or the vehicle was applied twice daily for four weeks.

Therapeutic effects were assessed us1xbet 신청g the 1xbet 신청vestigator's Global Assessment (IGA), a standard methodology 1xbet 신청 atopic dermatitis cl1xbet 신청ical trials that uses severity scor1xbet 신청g to evaluate systemic symptoms.

1xbet 신청 both the adult and pediatric trials, the IGA success rates, the primary endpo1xbet 신청ts as def1xbet 신청ed as the proportion of subjects whose IGA score was 0 (clear) or 1 (almost clear) and with improvement by at least 2 grades, were higher 1xbet 신청 the active-drug-treatment groups than 1xbet 신청 the vehicle groups, and the differences were statistically significant. No major adverse reactions were identified.

Trial outcomes will be analyzed further and f1xbet 신청d1xbet 신청gs will be announced at a scientific conference.

Otsuka entered 1xbet 신청to a licens1xbet 신청g agreement with Medimetriks, 1xbet 신청c. 1xbet 신청 2016 which granted Medimetriks development, market1xbet 신청g, and manufactur1xbet 신청g rights for difamilast 1xbet 신청 the United States.