Anacor Pharmaceuticals (NASDAQ:ANAC) today 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 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 3 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.
In addition to the primary and secondary endpoints noted above, 87.0% of patients treated with tavaborole 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.“We are pleased that tavaborole met all of the parameters outlined in our Special Protocol Assessment with the FDA with a high degree of statistical significance in this first Phase 3 trial. With its high rates of ‘completely clear’ or ‘almost clear’ nails, high negative culture rates, demonstrated safety and ease of use, we believe tavaborole could offer significant advantages over currently approved treatments for onychomycosis,” said David Perry, Chief Executive Officer of Anacor.
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