Ardea Biosciences Presents Preliminary Data from a Phase 1 Study of RDEA594 at the 2008 ACR/ARHP Annual Scientific Meeting
October 27 2008 - 8:00AM
Business Wire
Ardea Biosciences, Inc. (Nasdaq:RDEA) announced today that
preliminary data were presented from an ongoing Phase 1 trial of
RDEA594, its lead product candidate in development for the
treatment of hyperuricemia and gout, at the 2008 American College
of Rheumatology (ACR) / Association of Rheumatology Health
Professionals (ARHP) Annual Scientific Meeting in San Francisco,
California. Preliminary data from a Phase 1 single ascending dose
study of RDEA594 in healthy volunteers show that oral
administration of 100 mg of RDEA594 demonstrated a favorable
pharmacokinetic profile with low systemic clearance, favorable
absorption and a half-life supporting once-daily dosing.
Additionally, 100 mg of RDEA594 produced a significant increase in
urinary excretion of uric acid, confirming that RDEA594 is
responsible for the uric acid-lowering effects observed in previous
clinical studies of RDEA806, our lead non-nucleoside reverse
transcriptase inhibitor (NNRTI) in development for the treatment of
HIV. �These encouraging preliminary data confirm our selection of
RDEA594 as our lead product candidate for the treatment of
hyperuricemia and gout,� commented Barry D. Quart, PharmD,
president and chief executive officer. �Gout is a major medical
condition affecting millions of patients worldwide and there is
mounting evidence for an association between elevated uric acid and
the risk of cardiovascular and renal diseases in patients with
undiagnosed hyperuricemia and gout. We are working towards rapidly
completing the Phase 1 program evaluating the safety and uric acid
lowering effects of RDEA594 with higher single doses and multiple
daily dosing to allow us to enter Phase 2 early next year.� The
poster is available on the Company website (http://ardeabio.com)
under the title, �RDEA594, a Potential Uric Acid Lowering Agent
through Inhibition of Uric Acid Reuptake, Shows Better
Pharmacokinetics than its Prodrug RDEA806.� About RDEA594 RDEA594,
our lead product candidate for the treatment of hyperuricemia and
gout, currently in Phase 1 clinical development, is a major
metabolite of RDEA806, our lead NNRTI in clinical development for
the treatment of 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. 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 and is entering Phase 2b. 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. RDEA594, our lead product candidate for the
treatment of hyperuricemia and gout, is being evaluated in a Phase
1 clinical trial 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 1/2 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. 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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