Anacor Pharmaceuticals (NASDAQ:ANAC) announced today that it has completed the enrollment of approximately 600 patients in the second of its two Phase 3 trials of tavaborole (formerly known as AN2690), a topical anti-fungal product candidate for the treatment of onychomycosis, a fungal infection of the nail and nail bed that affects approximately 35 million people in the United States.
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. Top-line data from the first Phase 3 trial is expected around the end of 2012 and from the second Phase 3 trial in early 2013.
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