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Thu, December 16, 2010 Anacor Pharmaceuticals Announces First Patient Dosed in a Phase 3 Trial of AN2690 For Onychomycosis
PALO ALTO, Calif.--([ BUSINESS WIRE ])--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.
"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"
aWe 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,a said David Perry, Anacora™s Chief Executive Officer. aExisting 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.a
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.
aOur 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,a continued David Perry. aAchieving 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.a
About Anacor Pharmaceuticals
Anacor is a biopharmaceutical company focused on discovering, developing and commercializing novel small-molecule therapeutics derived from its boron chemistry platform. Anacor has discovered and is developing five clinical compounds, including its three lead programs: AN2690, a topical antifungal for the treatment of onychomycosis; AN2728, a topical anti-inflammatory PDE-4 inhibitor for the treatment of psoriasis; and GSK 2251052, or GSK a052 (formerly referred to as AN3365), a systemic antibiotic for the treatment of infections caused by Gram-negative bacteria, which has been licensed to GlaxoSmithKline under the companies' research and development agreement. In addition, Anacor is developing AN2718 as a topical antifungal product candidate for the treatment of onychomycosis and skin fungal infections, and AN2898 as a topical anti-inflammatory product candidate for the treatment of psoriasis and atopic dermatitis. For more information visit [ http://www.anacor.com ].
Forward-Looking Statements
This press release may contain forward-looking statements that relate to future events, including the development and commercialization of AN2690 and, more specifically, the enrollment and conduct of the AN2690 Phase 3 program. These forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause actual levels of activity, performance or achievement to differ materially from those expressed or implied by these forward-looking statements, including risks related to enrollment and successful completion of clinical trials, our lack of experience in conducting a Phase 3 clinical trial, risk of unforeseen side effects and risks related to regulatory approval for new drug candidates. These statements reflect the views of Anacor as of the date of this press release with respect to future events and, except as required by law, it undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this press release.
