Phase IV study shows Eucrisa well tolerated in young patients with atopic dermatitis

Pfizer announced top-line results from a Phase IV study (CrisADe CARE 1) which showed that Eucrisa (crisaborole ointment, 2%) was well-tolerated in children aged 3 months to less than 24 months with mild to moderate atopic dermatitis (AD), also known as eczema. The data from the trial are supportive of the primary study objective to examine the safety of crisaborole ointment 2% in this patient population, and are consistent with previous clinical trial experience. Crisaborole ointment 2% is currently approved in select countries for mild to moderate AD in patients two years of age and older. The primary endpoints of CrisADe CARE 1 were the number of patients with treatment-emergent adverse events (AEs) and severe adverse events (SAEs) and number of patients with clinically significant changes from baseline in height, weight, vital signs, electrocardiogram (ECG), and clinical laboratory parameters. Detailed analyses of the study will be submitted for presentation at a future scientific meeting.

Comment: Crisaborole is a novel boron-containing small molecule and, although the specific mechanism of action is not yet completely defined, Anacor believes that crisaborole inhibits PDE-4 in target cells, which reduces the production of pro-inflammatory cytokines thought to cause the signs and symptoms of atopic dermatitis.