Anacor Pharmaceuticals (NASDAQ:ANAC) today announced positive preliminary results from the second of two Phase 3 trials of tavaborole (known as Study 302). Tavaborole is a topical anti-fungal for the treatment of onychomycosis, a fungal infection of the nail and nail bed that affects approximately 35 million people in the United States. Results from the first Phase 3 trial (known as Study 301) were announced on January 29, 2013. In both studies, tavaborole achieved statistically significant and clinically meaningful results on all primary and secondary endpoints.
“We are pleased with the results of this study and we are on track with our plans to file an NDA in the middle of this year,” said David Perry, Chief Executive Officer of Anacor. “In both Phase 3 trials, tavaborole demonstrated better efficacy than ciclopirox lacquer, the only approved topical treatment for onychomycosis. Importantly, ciclopirox lacquer requires concomitant nail debridement. If approved, tavaborole could offer patients and prescribers a safe, effective and convenient topical treatment option for onychomycosis.”
“In Study 302, tavaborole achieved a complete cure rate of 9.1% in a patient population that we believe represents the majority of onychomycosis patients. In both of our Phase 3 studies, we allowed enrollment of adult patients of all ages who had up to 60% of their toenail affected by disease. While older patients and those with more extensive disease may be tougher to treat, we believe they represent an important and significant segment of the patient population. Approximately fifty percent of people over the age of 70 have onychomycosis, and often patients don’t seek treatment until the infection has progressed and involves a significant portion of the nail,” said Lee Zane, MD, Vice President of Clinical Development of Anacor. “In addition, 27.5% of patients in Study 302 achieved a completely clear or almost clear nail, which is a very meaningful endpoint to physicians and patients because it represents an excellent clinical response.”