Anacor Pharmaceuticals, Inc.'s Novel Topical Antifungal Agent For Onychomycosis Demonstrates Good Safety Profile And Diverse Activity In Multiple Preclinical Studies

SAN FRANCISCO and PALO ALTO, Calif., March 3 /PRNewswire/ -- Anacor Pharmaceuticals, a private pharmaceutical company developing novel agents for inflammatory and infectious diseases, today presented positive preclinical results for AN2690, the first in a new class of antifungal agents in development as a topical treatment for onychomycosis, a fungal infection of the toenail and fingernails.

The data demonstrated that AN2690 can effectively penetrate the nail plate and produces activity within and under the nail plate against the fungi most commonly found in infections of the nail and nail bed. AN2690 is currently being evaluated in Phase 2 clinical studies to confirm these findings with top-line data expected this year.

“Because onychomycosis is an infection of both the nail plate and bed, a topical drug must kill the fungi in the nail and penetrate to the bed underneath the nail,” said Dr. Jacob Plattner, senior vice president of Anacor. “We successfully addressed this challenge by applying a new class of antifungals based on our proprietary boron chemistry and specifically designed a molecule with potent antifungal properties and the physical properties necessary to effectively penetrate the nail. AN2690 penetrates human nails over two hundred fold better than current topical treatments.”

In the poster presentation entitled Microbiological Activity of AN2690, a New Antifungal Agent in Development for the Topical Treatment of Onychomycosis, Anacor scientists and their collaborators showed that AN2690 has broad-spectrum antifungal activity with minimum inhibitory concentration (MIC) values ranging from 0.25 - 8.0 mg/mL. AN2690 demonstrated remarkable ability to penetrate full thickness human fingernails at concentrations that prevent the growth of T. rubrum in an adapted zone-of-inhibition study. In addition, the MIC of AN2690 against 100 clinical isolates each of T. rubrum and T. mentagrophytes, the primary fungi that cause onychomycosis, ranged from 1.0 mg/mL to 8.0 mg/mL. AN2690 also was active in the presence of nail keratin.

AN2690 Phase 2 Program

Anacor is evaluating AN2690 in two Phase 2 studies. The first is an open-label study involving 60 patients with onychomycosis who will receive either a 5% or 7.5% concentration of AN2690 applied once a day for six months. The second study is a double-blind, placebo-controlled, six-month trial involving 180 patients who will receive either 2.5%, 5% or 7.5% concentrations of drug or a placebo applied daily. Primary endpoints for both studies are greater than 5 mm clear nail growth at six months, or nails judged by investigators to be “clear” or “almost clear,” and a negative culture for infection at the end of the trial period.

About Onychomycosis

Onychomycosis, a fungal infection of fingernails, toenails and the nail bed, affects up to 14% of the general U.S. population. The infection causes nail deformation, discoloration and splitting. Without treatment, the nails thicken and cause localized pressure-related pain. Dermatophytes, parasitic fungi that affect skin, hair or nails, are the primary agents that cause onychomycosis. Two dermatophyte strains, Trichophyton rubrum and Trichophyton mentagrophytes, account for over 90% of cases. Yeast-based infections are the second most common cause. Current approved topical treatments are rarely effective (less than 12%), and systemic treatments are effective in only approximately 50% of cases, yet have known toxicity. Systemic drugs for onychomycosis each sell over $1 billion annually.

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 a product candidate in Phase 2 clinical trials for atopic dermatitis and another in Phase 2 trials for onychomycosis, a fungal infection of fingernails and toenails that affects as much as 14% of the general U.S. population.

Anacor Pharmaceuticals

CONTACT: David Perry, Chief Executive Officer of Anacor Pharmaceuticals,+1-650-739-0700; or Daryl Messinger of WeissComm Partners, Inc.,+1-415-999-2361, or daryl@weisscommpartners.com, for Anacor Pharmaceuticals

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