�Ardea
Biosciences, Inc. (Nasdaq: RDEA) proclaimed 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 information was granted today by Dr. Graeme Moyle, Director
of HIV Research, Chelsea and Westminster Hospital, during a late breaker
seance at the XVII International AIDS Conference in Mexico City.
"We are highly pleased that the last results of the Phase 2a subject field
presented today demonstrate that 800 mg once daily produced like viral
load reductions as 400 mg twice daily, providing last confirmation that
RDEA806 deeds equally well given either once or twice daily. Based on the
information to date, we go on 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 comparison once day-to-day doses of
RDEA806 to efavirenz (SUSTIVA(R), Stocrin(R)) in first-line patients
receiving setting 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 'tween these agents, paving the way for
initiation of the Phase 2b survey."
The Phase 2a randomized, double-blind, placebo-controlled trial
evaluated the antiviral agent 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 modification from service line 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, untimely discontinuations, clinically relevant ECGs changes or
drug-related blizzard reported in any cohort. The incidence of CNS side effects
was similar between dose 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
(hypertext transfer protocol://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 verso transcriptase inhibitor
(NNRTI) for the potential difference treatment of HIV infection. Based on preclinical
and clinical studies to-date, we believe that RDEA806 may have crucial
competitive advantages compared to currently uncommitted NNRTIs. These
include the potential for potent antiviral agent activity against a wide-cut range of
HIV viral isolates, including those that are resistant to efavirenz
(Sustiva(R)) and other presently available NNRTIs; a highschool genetic barrier
to resistance; no reproductive toxicity based on creature studies; the
potential to be administered in a patient-friendly, unwritten 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 biotech
company focused on the discovery and development of small-molecule
therapeutics for the treatment of HIV, gouty arthritis, cancer and inflammatory
diseases. We have four mathematical product candidates in clinical trials and others in
presymptomatic development and discovery. Our most advanced product prospect
is RDEA806, an NNRTI, which has successfully realised a Phase 2a survey for
the treatment of patients with HIV. We have evaluated our second-generation
NNRTI for the handling of HIV, RDEA427, in a human micro-dose
pharmacokinetic study and have selected it for clinical evolution.
RDEA594, our lead product candidate for the treatment of gout, is in
preclinical development. We ar currently evaluating our leading MEK
inhibitor, RDEA119, in a Phase 1 study in advanced cancer patients and sustain
completed a Phase 1 study in normal hefty volunteers as a precursor to
trials in patients with inflammatory diseases. Lastly, we have evaluated
our second-generation MEK inhibitor for the discourse of genus Cancer and
inflammatory diseases, RDEA436, in a human micro-dose pharmacokinetic study
and get selected it for clinical development.
Statements contained in this press release regarding matters that are
not historical facts are "advanced statements" inside the significance 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, just are non 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 former studies. Risks that lead
to the uncertain nature of the forward-looking statements include: risks
related to the resultant of presymptomatic and clinical studies, risks related
to regulatory approvals, delays in commencement of preclinical and clinical
studies, and costs associated with our dose discovery and development
programs and line of work development activities. These and other risks and
uncertainties are described more fully in our most late filed SEC
documents, including our Annual Report on Form 10-K and our Quarterly
Reports on Form 10-Q, below the headings "Risk Factors." All
forward-looking statements contained in this press outlet speak merely as of
the date on which they were made. We undertake no obligation to update such
statements to reflect events that take place or circumstances that live after
the date on which they were made.
Ardea Biosciences, Inc.
http://www.ardeabio.com
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