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Anacor antifungal demonstrates safety in phase I trial

Anacor Pharmaceuticals has released data from a phase I trial of its lead compound, AN2690, showing that patients receiving the topical antifungal treatment had no measurable level of the drug in their bloodstream.

AN2690 is the first in a new class of antifungal agents that is being developed for onychomycosis, a fungal infection of the nail and nail bed.

The 15 patients in the absorption study, who were required to have at least eight infected nails, received daily treatments for 28 days with a 7.5% solution of AN2690. The drug could not be found at quantifiable levels (lower limit of quantification of 25 nanograms/ml) in the blood at any time point on days one, 14 and 28, when blood samples were taken.

Levels of AN2690 in the nail plate remained at therapeutic levels 14 days after the end of treatment. Anacor said that samples will continue to be collected to evaluate the drug concentrations in the nail at longer durations post-dosing.

“These new findings confirm preclinical toxicology work and showed that while the drug will concentrate at its target, the nail bed, it is not present at quantifiable levels in the bloodstream,” said Dr Karl Beutner, Anacor’s chief medical officer. “The level of drug found in the nail plate during AN2690 treatment was substantially higher than those found with currently available topical and oral agents.”

In addition, cultures of all nails were taken at the end of the 28 days of treatment, and all cultures were negative for the fungus, an early indication of potential clinical efficacy.

Anacor said that it has also completed enrollment in a 180-patient, double-blind, placebo-controlled study and in an additional 60-patient open-label study evaluating drug concentrations as low as 1%.