Source: Epilepsy Curr  |  Posted 5 years ago

LA GRANDE MOTTE, FRANCE, and PALO ALTO, C.A. -- 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 causes nails to deform, discolor and split.

The findings were presented today at the Perspectives in Percutaneous Penetration 10[^]th[] 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% solution and a 5% 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 6 months, or, nails judged by investigators to be "clear" or "almost clear;" and 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% 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, 6-month trial of 180 onychomycosis patients receiving 2.5%, 5% or 7.5% 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 7% to 10% of the U.S. population, including 48% 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% of cases. Yeast-based infections are the second most common cause.

Topical treatments succeed in fewer than 12% 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.

SOURCE: Anacor Pharmaceuticals