"We are pleased to announce the
"Onychomycosis is one of the most common diseases diagnosed and treated
by podiatrists. Historically, a large number of patients with
onychomycosis would choose not to treat their infection," said
"I am very excited about the release of this therapy for an infection
that is very difficult to treat," said
"KERYDIN was designed to be convenient for patients to use and has
demonstrated efficacy in the treatment of the fungal infection, thus
allowing growth of new uninfected nail," said
About KERYDIN™ (tavaborole) topical solution, 5%
KERYDIN (tavaborole) topical solution, 5%, is the first oxaborole antifungal agent developed for the topical treatment of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes.
KERYDIN is a clear, colorless, alcohol-based solution applied with a dropper to the infected toenail once daily for 48 weeks. Debridement of the nail is not required during the treatment period. Due to its topical application, KERYDIN has low systemic absorption and has not demonstrated systemic side effects.
The efficacy and safety of KERYDIN was evaluated in two multicenter, double-blind, randomized, vehicle-controlled trials. KERYDIN or vehicle was applied once daily for 48 weeks in subjects with 20% to 60% clinical involvement of the target toenail, without dermatophytomas or lunula (matrix) involvement. A total of 1194 subjects (795 KERYDIN, 399 Vehicle) 18 to 88 years of age, participated in these two trials. Efficacy assessments were made at 52 weeks following a 48-week treatment period.
The primary efficacy endpoint was "Complete Cure" at Week 52. "Complete Cure" is defined as "Completely Clear Nail" (0% clinical involvement of the target toenail) plus "Mycological Cure" (negative KOH wet mount and negative fungal culture). In the first trial, 6.5% of subjects treated with KERYDIN reached the primary endpoint, compared to 0.5% of subjects treated with vehicle. In the second trial, 9.1% of subjects treated with KERYDIN reached the primary endpoint, compared to 1.5% of subjects treated with vehicle.
Secondary endpoints in the pivotal trials included "Complete or Almost Complete Cure" (less than or equal to 10% affected target toenail area involved plus "Mycological Cure") and "Mycological Cure." 15.3% and 17.9% of patients treated with KERYDIN achieved "Complete or Almost Complete Cure" compared to 1.5% and 3.9% of patients treated with vehicle in the first and second trials, respectively. 31.1% and 35.9% of patients treated with KERYDIN achieved "Mycological Cure" compared to 7.2% and 12.2% of patients treated with vehicle in the first and second trials, respectively.
Common adverse reactions occurring in at least 1% of subjects treated with KERYDIN included application site exfoliation, ingrown toenail, application site erythema, and application site dermatitis. For information on dosage and administration, adverse reactions and other important safety and prescribing information please visit the page on KERYDIN, under the Pipeline tab on our website at www.anacor.com.
Onychomycosis is a progressive, recurring fungal infection of the nail
and nail bed. According to Podiatry Today, approximately 35
million people in
Anacor is a biopharmaceutical company focused on discovering, developing
and commercializing novel small-molecule therapeutics derived from its
boron chemistry platform. Anacor's first approved drug, KERYDIN™
(tavaborole) topical solution, 5%, is an oxaborole antifungal approved
This press release contains forward-looking statements, including
statements regarding the progress, timing and results of Anacor's
clinical trials, safety and efficacy of Anacor's product candidates,
timing and potential approval of Anacor's product candidates and timing
and potential commercial success of Anacor's products. These statements
constitute forward-looking statements within the meaning of Section 27A
of the Securities Act of 1933 and Section 21E of the Securities Exchange
Act of 1934. The words "may," "might," "will," "should," "estimate,"
"project," "plan," "anticipate," "expect," "intend," "outlook,"
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forward-looking statement in this press release except as required by
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assumptions by Anacor's management that, although believed to be
reasonable, are inherently uncertain and subject to a number of risks
and uncertainties. The following represent some, but not necessarily
all, of the factors that could cause actual results to differ from
historical results or those anticipated or predicted by Anacor's
forward-looking statements: Anacor's ability to timely and successfully
launch, either alone or with a partner, KERYDIN; any issues or delays
arising during the course of Anacor's Phase 3 studies or other clinical
trials relating to AN2728; any delay or failure by the
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