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Anacor Pharmaceuticals Completes Enrollment in Second of Two Phase 3 Trials of Tavaborole for Onychomycosis


//health-fitness.news-articles.net/content/2011/ .. se-3-trials-of-tavaborole-for-onychomycosis.html
Published in Health and Fitness on Thursday, December 22nd 2011 at 13:12 GMT by Market Wire   Print publication without navigation


PALO ALTO, Calif.--([ ])--Anacor Pharmaceuticals (NASDAQ:ANAC) announced today that it has completed the enrollment of approximately 600 patients in the second of its two Phase 3 trials of tavaborole (formerly known as AN2690), a topical anti-fungal product candidate for the treatment of onychomycosis, a fungal infection of the nail and nail bed that affects approximately 35 million people in the United States.

The tavaborole Phase 3 program consists of two double-blind, vehicle-controlled trials with two-to-one randomization between tavaborole and vehicle (the topical formulation without the active ingredient). The tavaborole 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 as agreed upon under a Special Protocol Assessment with the FDA. 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. Top-line data from the first Phase 3 trial is expected around the end of 2012 and from the second Phase 3 trial in early 2013.

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 six compounds that are currently in development including its lead compounds: tavaborole, a topical antifungal for the treatment of onychomycosis; AN2728 and AN2898, topical anti-inflammatory PDE-4 inhibitors for the treatment of psoriasis and atopic dermatitis; 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; and AN8194 which has been licensed to Eli Lilly and Company for an animal health application. Anacor is also developing AN2718 as a topical antifungal product candidate for the treatment of onychomycosis and skin fungal infections. 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 tavaborole, and more specifically, the conduct of the tavaborole Phase 3 programs. 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 our trials, risk of unforeseen side effects and risks related to regulatory approval of 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.


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