Phase 3 Results Announced for Tavaborole in Onychomycosis

Anacor Pharmaceuticals announced positive preliminary results from the first of two Phase 3 trials of tavaborole, its topical anti-fungal for onychomycosis, a fungal infection of the nail and nail bed.

The study (known as Study 301) is a Phase 3 study which enrolled 594 patients in the United States and Mexico with distal subungual onchomycosis, randomized 2:1 to receive either tavaborole, 5% solution or vehicle.

In this first Phase 3 study, 6.5% of patients treated with tavaborole met the primary endpoint of “complete cure” vs. 0.5% of patients treated with vehicle (P=0.001) at week 52. “Complete cure” is a composite endpoint that requires both a mycological cure and a completely clear nail. In the patients treated with tavaborole, 87% had a negative fungal culture vs. 47.9% in the vehicle-treated arm (p<0.001) at week 52, and 24.6% of patients treated with tavaborole achieved “completely clear” or “almost clear” nail and negative culture vs. 5.7% in the vehicle-treated arm (p<0.001) at week 52.

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