Anacor Pharmaceuticals (NASDAQ:ANAC) announced today that enrollment has been initiated and the first patient has been dosed in the Phase 3 program of AN2690, a topical antifungal product candidate for the treatment of onychomycosis. Onychomycosis is a fungal infection of the nail and nail bed that affects approximately 35 million people in the United States.
“We believe AN2690, with its unique antifungal mechanism of action and nail penetration qualities, could become a safe and effective topical treatment option for the tens of millions of people who suffer from onychomycosis,” said David Perry, Anacor’s Chief Executive Officer.
“Existing topical therapies for onychomycosis have demonstrated relatively low levels of efficacy and existing oral therapies for onychomycosis have been associated with rare but serious safety issues.”
The AN2690 Phase 3 program will consist of two double-blind, vehicle-controlled trials enrolling approximately 600 patients each. Two-thirds of the patients will be randomized to receive AN2690 while one-third will receive vehicle (the topical formulation without the active ingredient). The AN2690 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.
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.
“Our first clinical development goal following our IPO, which we closed on November 30th, was to begin enrollment in this Phase 3 program for AN2690 by the end of 2010,” continued David Perry. “Achieving this milestone keeps us on track to complete enrollment in this program in the second half of 2011 and report top-line Phase 3 data for AN2690 in the second half of 2012.”
Source: Anacor Pharmaceuticals