Anacor Pharmaceuticals (NASDAQ:ANAC) announced today that it has completed enrollment in the first of two Phase 3 trials of tavaborole (formerly known as AN2690), a topical anti-fungal product candidate for the treatment of onychomycosis. Onychomycosis is a fungal infection of the nail and nail bed that affects approximately 35 million people in the United States.
"We have completed enrollment of approximately 600 patients in the first of two Phase 3 trials for tavaborole. We expect to complete enrollment in our second Phase 3 trial by year-end 2011," said David Perry, Chief Executive Officer of Anacor Pharmaceuticals. "We believe that tavaborole can potentially offer significant improvements over the current standards of care for onychomycosis by combining the safety of a topical drug with significant efficacy. We anticipate top-line data from the first trial around year-end 2012."
The tavaborole Phase 3 program consists of two double-blind, vehicle-controlled trials with two-to-one randomization between tavaborole and vehicle (the topical formulation without the active ingredient). The tavaborole Phase 3 treatment regimen involves once-daily dosing for 48 weeks. The primary efficacy endpoint is a complete cure of the great toenail at week 52 as agreed upon under a Special Protocol Assessment with the FDA. Complete cure is a composite endpoint which requires both a mycologic cure and a completely clear nail. The length of the trial is determined primarily by the typical length of time that is required for new, clear nail to grow out to replace the diseased nail.
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