Ardea Biosciences Announces Positive Results from a Phase 1 Study of RDEA594

SAN DIEGO--(Business Wire)--
Ardea Biosciences, Inc. (Nasdaq:RDEA) today announced positive results from a
completed single ascending dose (SAD) Phase 1 clinical study of RDEA594, its
lead product candidate for the treatment of hyperuricemia and gout. The study
was conducted in normal healthy volunteers with serum uric acid above 5.0 mg/dL.
The results of this study demonstrated that single doses of up to 600 mg of
RDEA594 were well tolerated, with linear increases in drug levels observed
throughout the dose range investigated, and with up to an 11 hour elimination
half-life. There was also a dose related decrease in serum uric acid in the
first 24 hours after dosing. Overall reductions compared to placebo of up to 30%
in serum uric acid over the first 24 hours were observed with RDEA594, which is
about twice that observed in prior studies with a single 800 mg dose of
RDEA594`s prodrug, RDEA806, and is favorable to published results for
benzbromarone in normal healthy volunteers, a drug previously used to treat gout
patients that is believed to work via a similar mechanism of action. Ardea has
initiated a multiple ascending dose (MAD) study of RDEA594 in healthy volunteers
to investigate the safety, pharmacokinetics, and pharmacodynamics of RDEA594
administered once daily for 10 days.

"The results from the SAD study demonstrate the tolerability and potent activity
of RDEA594 in reducing serum uric acid," commented Barry D. Quart, PharmD,
president and chief executive officer. "We have continued our expedited
development of this compound with the initiation late last year of the MAD
study, which is designed to identify doses for the planned Phase 2 dose-response
study in gout patients later this year."

About RDEA594

RDEA594 is a major metabolite of RDEA806, our lead non-nucleoside reverse
transcriptase inhibitor (NNRTI) in clinical development for the treatment of
patients with human immunodeficiency virus (HIV). RDEA594 does not have
antiviral activity and is responsible for the uric acid-lowering effects
observed following administration of RDEA806 to over 150 subjects in Phase 1 and
Phase 2 clinical trials. RDEA594 is believed to be an inhibitor of the URAT1
transporter in the kidney, which is responsible for the regulation of uric acid
levels.

About Ardea Biosciences, Inc.

Ardea Biosciences, Inc., of San Diego, California, is a biotechnology company
focused on the discovery and development of small-molecule therapeutics for the
treatment of HIV, gout, cancer and inflammatory diseases. We have five product
candidates in clinical trials and others in preclinical development and
discovery. Our most advanced product candidate is RDEA806, an NNRTI, which has
successfully completed a Phase 2a study for the treatment of patients with HIV.
We have evaluated our second-generation NNRTI for the treatment of HIV, RDEA427,
in a human micro-dose pharmacokinetic study and have selected it for clinical
development based on a plasma half-life of greater than 40 hours. RDEA594, our
lead product candidate for the treatment of hyperuricemia and gout, is being
evaluated in Phase 1 clinical trials. We are evaluating our lead MEK inhibitor,
RDEA119, in a Phase 1/2 study in combination with sorafenib (Nexavar®, Onyx
Pharmaceuticals, Bayer HealthCare) and as a single agent in a Phase 1 study,
both in advanced cancer patients, and have completed a Phase 1 study in normal
healthy volunteers as a precursor to trials in patients with inflammatory
diseases. Lastly, we have evaluated our second-generation MEK inhibitor for the
treatment of cancer and inflammatory diseases, RDEA436, in a human micro-dose
pharmacokinetic study and have selected it for clinical development.

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 our plans and goals, the
expected properties and benefits of RDEA806, RDEA427, RDEA594, RDEA119, RDEA436
and our other compounds and the timing and results of our preclinical, clinical
and other studies and our financial performance.Risks that contribute to the
uncertain nature of the forward-looking statements include risks related to the
outcome of preclinical and clinical studies, risks related to regulatory
approvals, delays in commencement of preclinical and clinical studies, costs
associated with our drug discovery and development programs, and risks related
to the outcome of our business development activities.These and other risks and
uncertainties are described more fully in our most recently filed SEC documents,
including our Annual Report on Form 10-K and our 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.We
undertake no obligation to update such statements to reflect events that occur
or circumstances that exist after the date on which they were made.

Ardea Biosciences, Inc.
John Beck, 858-652-6523
jbeck@ardeabio.com

Copyright Business Wire 2009