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www.fdanews.com/articles/62851-anacor-s-topical-antifungal-study-shows-efficacy

ANACOR'S TOPICAL ANTIFUNGAL STUDY SHOWS EFFICACY

September 27, 2006

Anacor Pharmaceuticals has announced the end-of-treatment results from a 60-patient, Phase II, open-label study of 5 percent and 7.5 percent solutions AN2690 in onychomycosis, a fungal infection of the nail and nail bed. At six months, halfway through the study, 50 percent of patients in the 7.5 percent group and 45 percent of patients in the 5 percent dose group met the primary endpoint of the study, which was more than 2 mm of clear nail growth and a negative fungal culture.

Subjects were treated once daily with AN2690, a topical antifungal drug, and evaluated for both a clinical response by measuring the length of new clear nail growth as well as for the presence of fungi by culture and direct microscopic evaluation. Eight patients in the 7.5 percent group and seven patients in the 5 percent group had greater than 5 mm clear nail growth and negative fungal cultures.

The open-label study of AN2690 is one of three fully enrolled Phase II studies being conducted by Anacor. The second study is a double-blind, placebo-controlled, six-month trial of 180 patients who will receive 2.5 percent, 5 percent or 7.5 percent solutions of AN2690 or a placebo. The third trial is an open-label study of 60 patients with onychomycosis who will receive either a 1 percent dose of AN2690 daily for six months or a 5 percent dose AN2690 daily for one month followed by thrice-weekly treatment for an additional five months.