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Ardea Biosciences, Inc. Announces New Clinical Development Program Directed Toward the Treatment of Gout

- RDEA806 Shown to Produce Statistically Significant, Dose-Dependent

Reduction in Serum Uric Acid in Phase 1 Clinical Study - Phase 2 Efficacy Study in Gout Patients to Start in the First Half of


CARLSBAD, Calif., Nov. 28 /PRNewswire-FirstCall/ -- Ardea Biosciences, Inc. (Nasdaq: RDEA) today announced the initiation of a new clinical development program directed toward the treatment of gout. Gout, also known as metabolic arthritis, is a painful and debilitating disease caused by abnormally elevated levels of uric acid in the blood stream. These abnormally elevated levels lead to the deposition of uric acid crystals in and around the connective tissue of the joints and in the kidneys, leading to inflammation, the formation of disfiguring nodules (tophi), intermittent attacks of severe pain (acute flares), and kidney damage (nephropathy). An estimated 3-5 million people in the U.S. suffer from gout, which is the most common form of inflammatory arthritis in men over 40.

"We are extremely excited to be launching this new development initiative," said Barry D. Quart, Pharm.D., President and Chief Executive Officer. "Gout represents a major medical challenge in the U.S. and throughout the world, and, with no new treatments approved by the U.S. Food and Drug Administration for the underlying cause of gout in the past 40 years, there is a significant need for new therapeutic agents."

Phase 1 Experience

Earlier this year, Ardea conducted a comprehensive Phase 1 program in 98 healthy volunteers to evaluate the safety and pharmacokinetics of RDEA806, its lead non-nucleoside reverse transcriptase inhibitor (NNRTI) for the potential treatment of HIV. The Phase 1 program included a double-blind, placebo-controlled, multiple-ascending-dose (MAD) study in which 24 healthy volunteers received one of three doses of RDEA806 or placebo for 10-14 days. As reported earlier (, RDEA806 was safe and well-tolerated at all doses evaluated with no serious adverse events or clinically significant laboratory or ECG abnormalities. Furthermore, a trend toward a reduction in plasma cholesterol and triglyceride levels was reported.

Further analysis of the data from the MAD study showed a statistically significant, exposure-dependent reduction in serum uric acid (SUA). In the dose group that resulted in the highest plasma drug levels (400 mg modified-release capsule twice daily), there was a 50.9% placebo-adjusted reduction in SUA (p < 0.001). The following table summarizes the results by dose group.

Effect of RDEA806 on Serum Uric Acid (SUA) Levels in Phase 1 MAD Study

Mean SUA Level (mg/dL)

Baseline Day 3 Day 10/14[1] Change P Value[2]

Placebo 5.66 6.12 5.78 +3.0 %

300 mg BID [3] 6.19 4.50 4.15 -31.6 % < 0.001

500 mg BID [3] 4.94 2.94 3.06 -38.1 % < 0.001

400 mg MR BID [3][4] 5.25 2.99 2.80 -47.9 % < 0.001

[1] Patients receiving 300 mg and 500 mg BID were dosed for

14 days; patients receiving 400 mg MR BID were dosed for 10 days.

[2] ANCOVA model for the change from baseline versus placebo.

[3] BID = twice daily.

[4] MR= modified-release capsules. This dose group achieved the

highest plasma drug levels.

The magnitude of the uric acid reduction correlates with the individual's baseline uric acid level, such that the higher the baseline uric acid level, the larger the absolute uric acid reduction. On the last day of dosing, this correlation is highly statistically significant (p=0.004). To this end, the volunteers who met the accepted definition of hyperuricemia at baseline (SUA greater than 6.8 mg/dL, the limit of uric acid solubility in serum) experienced the greatest decrease, an average of 3.2 mg/dL on the last day of dosing.

Development Plan

Ardea is preparing to initiate a Phase 2, dose-ranging clinical efficacy study in gout patients with hyperuricemia in the first half of 2008. The Company is currently investigating the active moiety responsible for this pharmacological effect and its mechanism of action, as these may influence further development plans.

Current Treatment Options

Despite the well-understood etiology of gout, current treatment options are limited. There have been no new therapies approved by the FDA for the treatment of hyperuricemia associated with gout in the past 40 years, and the most-prescribed, FDA-approved pharmaceutical agent, allopurinol, has significant limitations. According to a large, randomized, clinical study, only 21% of patients receiving allopurinol achieve their treatment target, while 8% experienced serious adverse events (1).

Hyperuricemia in HIV

There is a high prevalence of hyperuricemia (elevated uric acid levels) in the HIV population. According to one large study, hyperuricemia is observed in 41% of HIV patients (2). Furthermore, HIV protease inhibitors were a significant risk factor for hyperuricemia (p < 0.003) in this study. "While we plan to target the uric acid-lowering effect demonstrated with RDEA806 administration principally at the gout opportunity, we also continue to move forward aggressively with our HIV development program. Reducing uric acid should be an added benefit to many HIV patients," said Dr. Quart.

Anticipated Milestone Events

The Company also reiterated today its goal to achieve its previously announced development milestone targets. These, together with the gout-related milestone targets announced today, include the following:

-- Initiation of a Phase 2a proof-of-concept trial in HIV patients with

our lead NNRTI, RDEA806, in the fourth quarter of 2007;

-- Initiation of a Phase 1 trial in advanced cancer patients with our

lead mitogen-activated ERK kinase (MEK) inhibitor, RDEA119, in the

fourth quarter of 2007;

-- Assessment of a next-generation NNRTI in a first-in-human micro-dosing

study in the fourth quarter of 2007;

-- Assessment of a next-generation MEK inhibitor in a first-in-human

micro-dosing study in the fourth quarter of 2007;

-- Completion of the HIV Phase 2a trial of RDEA806 in the first quarter

of 2008;

-- Initiation of a Phase 2 efficacy trial in gout patients with RDEA806

in the first half of 2008; and

-- Initiation of a clinical program to evaluate RDEA119 in inflammatory

diseases in the first half of 2008.

"We are excited about the continued progress of our deep product pipeline," stated Dr. Quart. "By the end of this year, we hope to have four novel molecules in the clinic for three distinct indications, with an additional one-to-two indications in inflammatory diseases planned for the first half of next year."

About Ardea Biosciences, Inc.

Ardea Biosciences is focused on the discovery and development of small-molecule therapeutics for the treatment of viral diseases, cancer and inflammatory diseases. The Company plans to have active development programs with four new chemical entities (NCEs) in the clinic for three distinct indications by the end of 2007, with an additional one-to-two indications in inflammatory diseases planned for the first half of 2008.

Ardea's most advanced clinical development programs include: RDEA806, the Company's lead NNRTI for the treatment of HIV, which is expected to enter a Phase 2a clinical trial in the fourth quarter of 2007; RDEA119, a mitogen-activated ERK kinase (MEK) inhibitor for the treatment of cancer and inflammatory diseases, which is expected to enter a Phase 1 clinical trial in advanced cancer patients in the fourth quarter of 2007; and RDEA806 for gout, which is expected to enter a Phase 2 efficacy trial in the first half of 2008. Ardea also is developing a next-generation NNRTI and a next-generation MEK inhibitor, both of which are scheduled to enter first-in-human studies in the fourth quarter of 2007.

(1) New England Journal of Medicine 2005;353;23:2450-61.

(2) Nephron Physiol 2006;103:p131-p138.

Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding: Ardea's goals, including its goal of having active development programs with four new chemical entities (NCEs) in the clinic for three distinct indications by the end of 2007, with an additional one-to-two indications in inflammatory diseases in the first half of 2008, the expected properties and benefits of its compounds and the results of clinical and other studies. Risks that contribute to the uncertain nature of the forward-looking statements include: risks related to the outcomes of preclinical and clinical trials, risks related to regulatory approvals, delays in commencement of preclinical and clinical tests, and costs associated with internal development and in-licensing activities. These and other risks and uncertainties are described more fully in Ardea's most recently filed SEC documents, including its Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, under the headings "Risk Factors." All forward-looking statements contained in this press release speak only as of the date on which they were made. Ardea undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

SOURCE Ardea Biosciences, Inc.
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