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ANACOR INTERIM PHASE 2 STUDY RESULTS SHOW AN2690 PENETRATES NAIL BED, KILLS FUNGI TO SUCCESSFULLY TREAT NAIL INFECTIONS
La Grande Motte, France and Palo Alto, CA — April 19, 2006 - Anacor Pharmaceuticals, a privately
held company, today announced preliminary results from an ongoing open-label Phase 2 study demonstrating that AN2690,
the first in a new class of antifungal agents, has potent clinical effects balanced with a favorable safety profile for
the potential treatment of onychomycosis, a fungal infection of the nail and nail bed, which affects seven to ten
percent of the U.S. population. This infection causes nails to deform, discolor and split.
The findings were presented today at the Perspectives in Percutaneous Penetration 10th International Conference in
La Grande Motte, France.
"Getting the treatment to penetrate through the nail and into the nail bed is the holy grail in treating this
persistent fungal infection most effectively," said Jacob Plattner, Senior Vice President of Research at Anacor.
"Currently available agents are either given systemically, which can cause unwanted side effects, or topically,
which do not penetrate the nail to the extent needed to target the dermatophytes that grow under the nail and
cause onychomycosis. AN2690's exceptional nail penetration and potent anti-fungal properties make it a promising
therapy for this disorder. Additional data from this trial and our ongoing placebo-controlled study will continue
to define the benefits of this unique topical compound."
Study Details and Results
The ongoing open-label Phase 2 trial is assessing two doses of topical AN2690 -- a 7.5 percent solution and a 5
percent solution, in 60 patients receiving once-daily treatment for 180 days.
The co-primary endpoints of the study are:
- Greater than 5 mm clear nail growth at six months, or, nails judged by investigators to be "clear" or "almost clear";
- A negative fungal culture.
At 90 days, or half-way through the study's treatment period, average clear nail growth is 2.6 mm (13 of 24
patients having greater than 2.5 mm clear nail growth) and 100 percent of the fungal culture samples were negative
at 30 days of treatment and beyond. Before-and-after photos also show visual improvement in the appearance of the
nail plate. AN2690 has been well-tolerated in the study so far with the most common side effect reported being
application site reactions.
Data from a preclinical study were also presented at the conference showing that AN2690 penetrated the nail bed more
than 200 times more effectively than ciclopirox, the only topical treatment approved for onychomycosis in the U.S.
AN2690 was found in far greater concentrations than ciclopirox throughout the nail and under the nail plate, where
it is most needed to eradicate the fungus that causes onychomycosis.
The Company is also conducting a double-blind, placebo-controlled, six-month trial of 180 onychomycosis patients
receiving 2.5 percent, 5 percent or 7.5 percent solutions of AN2690 or a placebo, applied daily. Primary endpoints
for this study are the same as for the open-label study, with the addition of a potassium hydroxide (KOH) assay test.
About Onychomycosis
Onychomycosis affects seven to ten percent of the U.S. population, including 48 percent of those over age 70. Without
treatment, the nails thicken and cause localized pressure-related pain. Dermatophytes are the primary fungi that
cause onychomycosis with two strains, Trichophyton rubrum and Trichophyton mentagrophytes, accounting for more than
90 percent of cases. Yeast-based infections are the second most common cause. Topical treatments succeed in fewer
than 12 percent of patients, yet achieve sales of approximately $300 million a year worldwide. Systemic treatments
are effective in approximately half of all cases, but have known toxicity. Sales of the largest selling systemic
drugs for onychomycosis each exceed $1 billion annually worldwide.
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About Anacor Pharmaceuticals
Anacor, a privately held, clinical-stage pharmaceutical company, is developing novel product candidates for
inflammatory and infectious diseases based on its proprietary, small-molecule, boron-based chemistry. Initially,
Anacor is focusing development efforts on dermatological disorders with AN2690 in Phase 2 trials for onychomycosis,
a fungal infection of nails and nailbeds. A second product candidate, AN0128, is in Phase 2 clinical trials for
atopic dermatitis.
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