Anacor Pharmaceuticals (NASDAQ:ANAC) announced today that it has
completed enrollment in the first of two Phase 3 trials of tavaborole
(formerly known as AN2690), a topical anti-fungal 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 have completed enrollment of approximately 600 patients in the first
of two Phase 3 trials for tavaborole. We expect to complete enrollment
in our second Phase 3 trial by year-end 2011,” said David Perry, Chief
Executive Officer of Anacor Pharmaceuticals. "We believe that tavaborole
can potentially offer significant improvements over the current
standards of care for onychomycosis by combining the safety of a topical
drug with significant efficacy. We anticipate top-line data from the
first trial around year-end 2012.”
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.
Tavaborole granted as generic name for AN2690
Anacor also announced that the United States Adopted Name (USAN) Council
has granted tavaborole as the generic name for AN2690. The USAN Council
serves health professions of the United States by selecting simple,
informative and unique nonproprietary names for drugs by establishing
logical nomenclature classifications based on pharmacological and/or
chemical relationships.
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 five compounds that are
currently in clinical development, including its three lead programs:
tavaborole, 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 ‘052 (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
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.
