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Ardea Biosciences announces positive preclinical, clinical results

Shares of Ardea Biosciences Inc. (Nasdaq: RDEA) lifted more than 4 percent after the San Diego company announced positive results in clinical studies of lead candidate RDEA594.

Gout patients with hyperuricemia, or high levels of uric acid in the blood, have responded well to RDEA594 in an ongoing Phase 2a, proof-of-concept study, Ardea said in a release.

Six of seven patients treated with RDEA594 saw reductions in target uric acid concentrations in the first eight days of dosing, compared to zero out of four patients randomized to placebo and two out of three patients randomized to a standard dose of allopurinol.

Ardea started the trial in late April and expects to finish dosing in late June. There have been no serious adverse effects or premature discontinuations among the 20 patients so far, Ardea said in a release.

The company also announced results from two Phase 1 studies of RDEA594. Seventy-six patients of 98 adult male subjects received varying doses for one to 10 days.

Statistically significant, dose-dependent reductions in serum urate of up to 45 percent were demonstrated in the multiple-ascending-dose study.

RDEA594 was well tolerated at all dose levels tested, Ardea added. Adverse events were mild to moderate in severity with no change with increasing dose, and no serious adverse events or discontinuations due to adverse events.

“With the RDEA594 proof-of-concept data now in hand and our recent experience rapidly enrolling gout patients, we look forward to successfully completing major components of our Phase 2b evaluation of RDEA594 as planned in the fourth quarter of 2009,” said Barry D. Quart, Ardea’s president and chief executive officer, in a release.

Ardea rose 62 cents to close at $15.86.

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