Anacor Pharmaceuticals, Inc.
) recently announced positive preliminary results on tavaborole
(AN2690) from Study 301. Tavaborole is being developed for the
prevention of onychomycosis.
According to information provided by Anacor, roughly 35
million people in the US suffer from onychomycosis, a fungal
infection of the nail and nail bed.
Study 301 is the first of two phase III clinical trials of
tavaborole in onychomycosis. The study was conducted under the US
Food and Drug Administration's (FDA) Special Protocol Assessment
(SPA) program. The double-blind, vehicle-controlled trial
enrolled roughly 594 patients and was conducted in the US and
The study met both the primary and secondary endpoints. The
primary endpoint included the achievement of "complete cure"
(6.5% of patients in the tavaborole arm compared to 0.25% in the
Secondary endpoints included the achievement of a "completely
clear" or "almost clear" nail (26.1% of patients in the
tavaborole arm compared to 9.3% in the vehicle-treated arm),
achievement of mycological cure (31.1% of patients in the
tavaborole arm compared to 7.2% in the vehicle-treated arm) and
the achievement of "completely clear" or "almost clear" nail with
mycological cure (15.3% of patients in the tavaborole arm
compared to 15% in the vehicle-treated arm).
Data from the second phase III double-blind,
vehicle-controlled study (Study 302) conducted in the US and
Canada is expected in Mar 2013.
Despite presenting positive data from the study, Anacor's
shares were down more than 20% on the news. Although tavaborole
met its primary and secondary endpoints, results presented by
) on its onychomycosis candidate, efinaconazole, were much more
favorable (17.8% of patients in the efinaconazole arm were
completely cured compared to only 3.3% in the vehicle arm). As
far as the secondary endpoints of complete or almost complete
cure and complete mycologic cure, the success rates for
efinaconazole were 26.4% and 23.4%, respectively.
Although tavaborole did not achieve the same level of efficacy
as efinaconazole, the positive results and potentially favorable
results from the second phase III study should allow the company
to go ahead with the filing of a new drug application in the US
Anacor carries a Zacks Rank #3 (Hold). Some stocks in the
pharmaceutical sector that currently carry a Zacks Rank #1
(Strong Buy) are
Salix Pharmaceuticals Ltd.
) and Valeant.
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