�Ardea Biosciences, Inc.
(Nasdaq: RDEA) announced that the Medicines and Healthcare products
Regulatory Agency (MHRA) in the United Kingdom has authorized a Phase 1
study evaluating RDEA594 in normal respectable volunteers. RDEA594 is the
Company's tether product candidate for the treatment of gout.
"Regulatory clearance for us to proceed with our Phase 1 work of
RDEA594, within sise months from designation as a clinical candidate is a
testament to the efficiency of our development organization, and the
importance we station on our gout political platform -- a program we intend to expand
with second-generation compounds from our exciting ongoing research in this
region," said Barry D. Quart, PharmD, Ardea Biosciences' President and CEO.
"Earlier this quarter, we initiated a Phase 2a proof-of-concept cogitation of
RDEA806, a prodrug of RDEA594, which should allow us to provide an early
confirmation of RDEA594's activeness in the target population of patients
with gouty arthritis."
This Phase 1, randomized, double-blind, placebo-controlled trial will
evaluate the safety, tolerability, pharmacokinetics and uric acidulent lowering
effects of single ascending oral doses of RDEA594 in healthy grownup male
volunteers.
About Gout
An estimated xxxv million people in the United States, and close to
5 1000000 people in the European Union, suffer from gout, which is the to the highest degree
common form of inflammatory arthritis in men over 40. Gout, also known as
metabolous arthritis, is a painful and debilitating disease caused by
abnormally elevated levels of uric acid in the blood stream. These
abnormally lofty levels lead to the deposition of uric acidic crystals in
and around the connexion tissue of the joints and in the kidneys, leading
to inflammation, the formation of disfiguring nodules (tophi), intermittent
attacks of severe hurting (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 get been approved by the FDA for the handling of
hyperuricemia associated with gout in the past 40 years
About RDEA594
RDEA594, our booster cable product candidate for the treatment of gout, is a
major metabolite of RDEA806, our lead non-nucleoside reverse transcriptase
inhibitor (NNRTI) in clinical development for the discourse of HIV. RDEA594
does not have antiviral action and is believed to be creditworthy for the
uric acid-lowering effects discovered following establishment of RDEA806 to
over 100 subjects in Phase 1 and Phase 2 clinical trials. In Phase 1
studies of RDEA806 in normal healthy volunteers, increased urinary
excretion of uric vitriolic was ascertained in the first 24 hours after dosing,
with statistically significant, exposure-dependent, decreases in serum uric
acidic of 35% to 50% observed during multiple dosing out to 14 days.
About RDEA806
RDEA806 is a novel NNRTI for the potential intervention of HIV infection.
Based on preclinical and clinical studies to date, we believe that RDEA806
may have important competitive advantages compared to currently useable
NNRTIs. These include the potential for potent antiviral drug activity against a
wide-eyed range of HIV viral isolates, including those that are resistant to
efavirenz (Sustiva(R)) and other currently available NNRTIs; a senior high genetic
barrier to resistance; limited pharmacokinetic interactions with other
drugs; no reproductive toxicity based on fauna studies; and the potency
to be readily co-formulated in a single pill with other HIV antiviral
drugs, such as Truvada(R) (emtricitabine and tenofovir) from Gilead
Sciences, Inc, which is of import for patient compliance.
About Ardea Biosciences, Inc.
Ardea Biosciences, Inc., of San Diego, California, is a biotech
company focussed on the discovery and development of small-molecule
therapeutics for the treatment of HIV, urarthritis, cancer and inflammatory
diseases. We suffer five merchandise candidates in clinical trials and others in
preclinical development and discovery. Our most advanced product prospect
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 discourse of HIV, RDEA427, in a human micro-dose
pharmacokinetic study and have selected it for clinical development.
RDEA594, our lead mathematical product candidate for the discourse of gout, is organism
evaluated in a Phase 1 study. We ar currently evaluating our lead MEK
inhibitor, RDEA119, in a Phase 1 study in advanced cancer patients, and
make completed a Phase 1 study in normal good for you volunteers as a forerunner
to trials in patients with incitive diseases. Lastly, we get 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 signification of
the Private Securities Litigation Reform Act of 1995. Because such
statements are theme to risks and uncertainties, actual results may
dissent materially from those explicit 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 issue of preclinical and clinical studies, risks related
to regulatory approvals, delays in commencement of preclinical and clinical
studies, and costs associated with our do drugs discovery and development
programs and business development activities. These and other risks and
uncertainties are described more fully in our most lately 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 be after
the date on which they were made.
Ardea Biosciences, Inc.
http://www.ardeabio.com
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