Tavaborole (Anacor Pharma) success in Phase III for Onychomycosis

Anacor Pharmaceuticals has announced positive preliminary results from the first of two Phase III trials of tavaborole, its topical anti-fungal for Onychomycosis, a fungal infection of the nail and nail bed that affects approximately 35 million people in the United States. Tavaborole achieved a high degree of statistical significance on all primary and secondary endpoints.

In this first Phase III study (known as Study 301), 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.

Among the secondary endpoints, 26.1% of patients treated with tavaborole achieved a "completely clear" or "almost clear" (?10% clinical involvement) nail vs. 9.3% in the vehicle-treated arm (p < 0.001) at week 52.

31.1% of patients treated with tavaborole achieved mycological cure vs. 7.2% in the vehicle-treated arm (p < 0.001) at week 52. Mycological cure is the absence of fungus as determined by a negative potassium hydroxide ("KOH") examination and a negative fungal culture.

15.3% of patients treated with tavaborole achieved "completely clear" or "almost clear" nail with mycological cure vs. 1.5% in the vehicle-treated arm (p < 0.001) at week 52.

Study 301 is the first of two Phase III clinical trials of tavaborole in Onychomycosis.