Data from two Phase III trials in adult and pediatric patients for MM 36 showed statistically significant improvements in atopic dermatitis.- Medimetriks Pharmaceuticals

Medimetriks Pharmaceuticals announced that its partner, Otsuka Pharmaceuticals Co. Ltd., achieved positive results in two Phase III Japanese clinical trials in adult and pediatric patients for MM 36 (difamilast), a novel topical, non-steroidal phosphodiesterase IV (PDE4) inhibitor for the treatment of mild to moderate atopic dermatitis. One study was in adult patients and the other was in pediatric patients.

In both the adult and pediatric trials, the success rates of the Investigator’s Global Assessment (IGA), a standard methodology in atopic dermatitis clinical trials that uses severity scoring to evaluate systemic symptoms (the primary endpoints as defined 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 in the active-drug-treatment groups than in the vehicle groups, and the differences were statistically significant. No major adverse reactions were identified. Trial outcomes will be analyzed further and findings will be announced at a scientific conference.

Comment: Difamilast is a novel atopic dermatitis drug candidate discovered by Otsuka that has phosphodiesterase 4 (PDE4) inhibitory activity. PDE4 inhibitors are believed to improve the symptoms of atopic dermatitis through suppression of the production of chemical mediators such as pro-inflammatory cytokines and through other anti-inflammatory effects. The two trials were conducted as multicenter, randomized, double-blind, vehicle-controlled (i.e., comparator), parallel-group studies. In the adult study, 1% difamilast ointment or the vehicle was applied twice daily for four weeks. In the pediatric study, 0.3% or 1% difamilast ointment or the vehicle was applied twice daily for four weeks.