MEXICO CITY and SAN DIEGO, Aug. 7 /PRNewswire-FirstCall/ -- Ardea
Biosciences, Inc. (Nasdaq: RDEA) today announced that data was presented from
its completed Phase 2a proof-of-concept monotherapy study of RDEA806, the
Company's novel investigational non-nucleoside reverse transcriptase inhibitor
(NNRTI) for patients with human immunodeficiency virus (HIV), demonstrating
robust antiviral activity with a well-tolerated profile. An oral presentation
of the data was given today by Dr. Graeme Moyle, Director of HIV Research,
Chelsea and Westminster Hospital, during a late breaker session at the XVII
International AIDS Conference in Mexico City.
"We are extremely pleased that the final results of the Phase 2a study
presented today demonstrate that 800 mg once daily produced similar viral load
reductions as 400 mg twice daily, providing final confirmation that RDEA806
works equally well given either once or twice daily. Based on the data to
date, we continue to believe that RDEA806 has the potential to be a first-line
therapy for the treatment of HIV," said Barry D. Quart, PharmD, Ardea's
President and CEO. "We look forward to further evaluating RDEA806 and are on
track to begin a Phase 2b study comparing once daily doses of RDEA806 to
efavirenz (SUSTIVA(R), Stocrin(R)) in first-line patients receiving background
treatment with Truvada(R) (emtricitabine and tenofovir disoproxil fumarate),
in the third quarter of this year. A recently completed drug interaction
study with RDEA806 and Truvada confirmed the lack of drug-drug interactions
between these agents, paving the way for initiation of the Phase 2b study."
The Phase 2a randomized, double-blind, placebo-controlled trial evaluated
the antiviral activity, pharmacokinetics, safety and tolerability of once- and
twice-daily oral dosing regimens of RDEA806 versus placebo in 48 HIV-positive
patients who were naive to antiretroviral treatment. Nine out of 12 patients
in each of four cohorts received RDEA806. The primary efficacy end point was
the change from baseline in plasma viral load. Results from all four cohorts
showed a median reduction in plasma viral load at nadir of 1.8 - 2.0 log
copies/mL. There were no serious adverse events, premature discontinuations,
clinically relevant ECGs changes or drug-related rash reported in any cohort.
The incidence of CNS side effects was similar between drug and placebo.
Gastrointestinal side effects were most common, but these effects were
generally transient and mild.
The presentation is available on the conference website
(http://www.aids2008.org) and on the Company website (http://www.ardeabio.com)
under the title "Antiviral activity of RDEA806, a novel HIV non-nucleoside
reverse transcriptase inhibitor, in treatment of naive HIV patients."
About RDEA806
RDEA806 is a novel non-nucleoside reverse transcriptase inhibitor (NNRTI)
for the potential treatment of HIV infection. Based on preclinical and
clinical studies to-date, we believe that RDEA806 may have important
competitive advantages compared to currently available NNRTIs. These include
the potential for potent antiviral activity against a wide range of HIV viral
isolates, including those that are resistant to efavirenz (Sustiva(R)) and
other currently available NNRTIs; a high genetic barrier to resistance; no
reproductive toxicity based on animal studies; the potential to be
administered in a patient-friendly, oral dosing regimen; limited
pharmacokinetic interactions with other drugs; and the ability to be
co-formulated with other HIV antiviral drugs.
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 four 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. RDEA594, our lead product
candidate for the treatment of gout, is in preclinical development. We are
currently evaluating our lead MEK inhibitor, RDEA119, in a Phase 1 study 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 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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