Anacor Pharmaceuticals (ANAC) announced positive results from a Phase 2 dose-ranging trial or AN2728-AD-204 of its topical boron-based phosphodiesterase-4 (PDE-4) inhibitor, AN2728. The study included 86 adolescents (ages 12 - 17) with mild-to-moderate atopic dermatitis, a chronic rash which predominantly affects children and is characterized by inflammation and itching.
In this study, lesions treated with AN2728 ointment, 2.0% twice daily for 28 days achieved a 71% improvement from baseline in their Atopic Dermatitis Severity Index or ADSI score, with 66% of lesions in this treatment group achieving total or partial clearance. AN2728 was generally safe and well-tolerated. Most adverse events were mild and largely unrelated to study drug.
"These results demonstrate a clear dose response across the four dosing regimens and identify the AN2728 ointment, 2.0% BID dosing regimen as optimal for a Phase 3 program, which we expect to initiate around the end of 2013," said David Perry, Chief Executive Officer of Anacor Pharmaceuticals.
The Phase 2 randomized, double-blind, bilateral study enrolled adolescent patients with mild-to-moderate atopic dermatitis. Patients were randomized 1:1 to either once daily (QD) or twice daily (BID) application for 28 days. Patients were instructed to apply AN2728 ointment, 2.0% to one target lesion and AN2728 ointment, 0.5% to a comparable target lesion.
The primary endpoint was the change from baseline ADSI score, which is the sum of the severity scores of five clinical features (erythema, pruritus, exudation, excoriation and lichenification) from 0 (none) to 3 (severe) for each feature, for a total score of 0 to 15. Additional endpoints included differences in ADSI component subscores and safety.
A clear dose response was demonstrated in this study, with AN2728 ointment, 2.0% BID yielding the greatest improvement, the company said.
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