Ardea Biosciences' Advances RDEA806 Into Phase 2a Proof-of-Concept Study For Gout

Ardea Biosciences, Inc.
(Nasdaq: RDEA) announced that it has received regulatory approval to
begin a Phase 2a proof-of-concept clinical trial evaluating RDEA806 in gout
patients with hyperuricemia. Gout, also known as metabolic arthritis, is a
painful and debilitating disease caused by abnormally elevated levels of
uric acid in the blood stream, and is the most common form of inflammatory
arthritis in men over 40. The Company also announced that gout specialist,
Dr. Fernando Perez-Ruiz in Spain, will be the newest member of its
inflammatory disease scientific advisory board (SAB).


Ardea previously announced the designation of RDEA594, a major
metabolite of RDEA806, the Company's lead human immunodeficiency virus
(HIV) development compound, as its lead development candidate for the
treatment of patients with gout. RDEA594 does not have antiviral activity,
but is believed to be responsible for essentially all of the uric acid
lowering effects seen with RDEA806. Uric acid lowering effects have been
observed following administration of RDEA806 in Phase 1 and Phase 2
clinical trials that included over 100 subjects.



"The Phase 2a trial should allow us to confirm RDEA594's activity in
the target population of patients with gout using its prodrug, RDEA806.
Enrollment in the Phase 2a trial should begin shortly and we are on track
to initiate a Phase 1 trial with RDEA594 in the second half of this year,"
said Barry D. Quart, PharmD, Ardea Biosciences' President and CEO. "We also
are extremely pleased to add Dr. Fernando Perez-Ruiz to our inflammatory
diseases SAB. Dr. Perez-Ruiz has extensive experience treating gout
patients with drugs of the same class as RDEA594."



The Phase 2a randomized, double-blind, dose ranging, efficacy and
safety trial will be conducted in academic medical centers in Europe and
Canada. In this trial, we plan to evaluate the serum uric acid (sUA) level,
pharmacokinetics, safety and tolerability of two different dose regimens of
RDEA806 versus placebo in establishing normal sUA concentrations in gout
patients with hyperuricemia (greater than or equal to 8.0 mg/dl). The
primary efficacy endpoint is the proportion of subjects whose sUA level is
less than 6.0 mg/dl following four weeks of treatment.



Dr. Fernando Perez-Ruiz is an Assistant Head of the Rheumatology
Division at the Hospital de Cruces in Vizcaya, Spain. He received his
medical degree from the Basque Country University in Bilbao, Spain, and a
PhD from Barcelona University, Spain. Board-certified in Rheumatology, Dr.
Perez-Ruiz is a member of the American College of Rheumatology and Spanish
Society for Rheumatology and has collaborated with the European League
Against Rheumatism (EULAR) Task Force for Gout and with the Outcome
Measures for Rheumatic Arthritis Clinical Trials (OMERACT) group for
chronic gout. He serves on the editorial boards of Arthritis Rheumatism
(Care & Research), Bone Joint Spine, and Reumatologia Clinica and serves as
a reviewer for more than 20 international journals. His research interests
include crystal-induced arthritis, especially gout, but he has also
investigated lupus, rheumatoid arthritis and fibromyalgia. Dr. Perez-Ruiz
has published more than 80 articles on topics related to rheumatology, and
most frequently to hyperuricemia and gout.
















About Gout



An estimated 3-5 million people in the United States suffer from gout,
which is the most common form of inflammatory arthritis in men over 40.
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). While gout is a treatable condition, there are
limited treatment options, and a number of adverse effects are associated
with current therapies. No new therapies have been approved by the FDA for
the treatment of hyperuricemia associated with gout in the past 40 years.



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, cancer and inflammatory diseases,
including gout. We have four drug candidates in clinical trials and others
in preclinical development and discovery. Our most advanced development
candidate is RDEA806, a non-nucleoside reverse transcriptase inhibitor
(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 as a development candidate based
on its long plasma half-life. RDEA594, our lead development candidate for
the treatment of gout, is in preclinical development and is believed to be
an inhibitor of the URAT1 transporter in the kidney, which is responsible
for regulation of uric acid levels. We are evaluating our lead MEK
inhibitor, RDEA119, in a Phase 1 study in advanced cancer patients, as well
as in 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 as a development candidate.



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 goals, including the expected properties and benefits of
RDEA806, RDEA427, RDEA594, RDEA119, RDEA436 and our other compounds and the
results of preclinical, clinical and other studies. 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, and costs associated with our drug discovery and development
programs and 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.


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