Phase III results significant for crisaborole in atopic dermatitis- Anacor Pharma

Anacor Pharmaceuticals announced preliminary top-line results from its two Phase III pivotal studies of Crisaborole Topical Ointment, 2% (formerly AN 2728), for the potential treatment of mild-to-moderate atopic dermatitis in children and adults. In both studies, crisaborole achieved statistically significant results on all primary and secondary endpoints and demonstrated a safety profile consistent with previous studies. The pivotal studies of crisaborole consisted of two multi-center, double-blind, vehicle-controlled studies of over 750 patients each, aged 2 years and older with mild-to-moderate atopic dermatitis (defined as an ISGA score of 2 (mild) or 3 (moderate)). The primary efficacy endpoint was success in ISGA at day 29 (defined as the proportion of patients achieving an ISGA score of 0 (clear) or 1 (almost clear) with at least a 2-grade improvement from baseline). Secondary endpoints included the proportion of patients achieving an ISGA score of 0 or 1, irrespective of a minimum 2-grade improvement, at day 29 and time to success in ISGA.

The safety results were consistent with previous studies. The majority of adverse events in crisaborole-treated patients were graded as mild in severity. The most common adverse events occurring on a pooled basis across both studies in ? 2% of patients were application site pain (4.4% and 1.2% for crisaborole and vehicle, respectively) and upper respiratory tract infections (3.0% and 3.0% for crisaborole and vehicle, respectively). There were no treatment-related serious adverse events among patients treated with crisaborole.