Ardea Biosciences Announces Positive Results from a Phase 1 Study of RDEA594
January 12 2009 - 8:30AM
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.
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