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8-K - 8-K - Ardea Biosciences, Inc./DE | a54060e8vk.htm |
EX-99.1 - EX-99.1 - Ardea Biosciences, Inc./DE | a54060exv99w1.htm |
Exhibit 99.2
DRAFT |
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Ardea Contact:
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John Beck | |
Ardea Biosciences, Inc. | ||
(858) 652-6523 | ||
jbeck@ardeabio.com | ||
Media Contact:
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Heidi Chokeir, Ph.D. | |
Russo Partners, LLC | ||
(619) 528-2217 | ||
heidi.chokeir@russopartnersllc.com |
Ardea Biosciences Announces Additional Positive Results from a Phase 2a Study of RDEA594 at the
2009 ACR/ARHP Annual Scientific Meeting
2009 ACR/ARHP Annual Scientific Meeting
RDEA594 Significantly Reduced Serum Urate Levels in Gout Patients and Was Well Tolerated
Conference Call and Webcast Scheduled for 11:30 A.M. Eastern Time Today
SAN DIEGO, October 19, 2009 Ardea Biosciences, Inc. (Nasdaq: RDEA) today announced additional
positive results from the completed first cohort of an ongoing Phase 2a, proof-of-concept study of
RDEA594, its lead product candidate for the treatment of hyperuricemia and gout. These results, as
well as data from a preclinical drug-drug interaction study demonstrating RDEA594s potential to be
used in combination with allopurinol and febuxostat (Uloric®, Takeda Pharmaceutical
Company Limited; Adenuric®, Ipsen), are being presented today at the 2009 American
College of Rheumatology (ACR) / Association of Rheumatology Health Professionals (ARHP) Annual
Scientific Meeting in Philadelphia, Pennsylvania.
In the first cohort of this small placebo- and active-controlled study of 21 gout patients with
hyperuricemia (serum urate ≥ 8 mg/dL), 11 patients were randomized to blinded RDEA594 200 mg
once-daily (qd) for one week followed by RDEA594 400 mg qd for one week, 5 patients were randomized
to blinded placebo for two weeks and 5 patients were randomized to open-label allopurinol 300 mg qd
for two weeks. All patients receiving RDEA594 experienced a dose-related reduction in uric acid
levels in their blood. Patients who excrete less than normal amounts of uric acid make up
approximately 90% of the gout patient population and are the primary target for treatment with
RDEA594. In this study, the response rate (response defined as serum urate to < 6 mg/dL) to
RDEA594 in these patients was 60% (6/10) after two weeks of treatment. A majority of patients
randomized to RDEA594 also had mild to moderate renal impairment (Creatinine Clearance by
Cockcroft-Gault method = 50-89 ml/min) at baseline and 86% of those patients responded to RDEA594
at two weeks.
RDEA594 increased urinary excretion of uric acid in the under-excretor patients in this study to
pre-treatment levels seen in normal healthy volunteers in prior studies. Avoiding excessive
clearance of uric acid should reduce the risk of renal toxicity. RDEA594 was also well tolerated
in this study, with no serious adverse events and no premature discontinuations due to adverse
events in patients receiving RDEA594.
In the ongoing second cohort of this trial, 6 gout patients with hyperuricemia (serum urate ≥ 9
mg/dL) will receive allopurinol 300 mg qd for one week followed by the addition of RDEA594 or
placebo for two more weeks.
Preclinical models did not show any drug-drug interactions between RDEA594 and either allopurinol
or febuxostat. Ongoing studies in humans will provide additional evidence to support the potential
use of these combinations. An update on animal safety studies was also presented with recent
results from a 3-month and 6-month assessment of chronic toxicity in rats and monkeys,
respectively, showing no organ toxicity with RDEA594. In particular, no renal toxicity was noted
in clinical chemistry, gross pathology or histopathology at doses up to 300 mg/kg/day.
RDEA594 continues to move through clinical development with an impressive efficacy and safety
profile. The significant activity observed in patients with mild to moderate renal impairment, a
substantial group of gout patients that are not effectively treated with allopurinol, is extremely
encouraging, commented Barry D. Quart, PharmD, Ardeas president and chief executive officer.
Results presented today provide an important first look at what we expect to see in the larger
single-agent Phase 2b dose-response trial now underway, as well as validation of the doses
selected for all studies in the Phase 2 program.
The ACR/ARHP posters are available on the Companys website (http://www.ardeabio.com) under the
titles, RDEA594, a Novel Uricosuric Agent, Significantly Reduced Serum Urate Levels and Was Well
Tolerated in a Phase 2a Pilot Study in Hyperuricemic Gout Patients and Evaluation of Drug-Drug
Interaction Potential Between RDEA594, Allopurinol and Febuxostat in Preclinical Species.
Ardea will host a live conference call and webcast on Monday, October 19, 2009 at 11:30 a.m.
Eastern Daylight Time. The conference call will be hosted by Barry D. Quart, PharmD, Ardeas
president and chief executive officer, and Kimberly J. Manhard, Senior Vice President of Regulatory
Affairs and Operations and will include Mark C. Genovese, MD Professor of Medicine and Co-Chief of
the Division of Immunology and Rheumatology at Stanford University Medical Center and John S.
Sundy, MD, PhD Associate Professor of Medicine and Head of the Section of Allergy and Clinical
Immunology in the Division of Pulmonary, Allergy and Critical Care Medicine at Duke University
Medical Center.
The conference call can be accessed by dialing 800-638-4930 for domestic callers and 617-614-3944
for international callers. Please use passcode: 94791770. The conference call and slide
presentation will be webcast live under the investor relations section of Ardeas website at
www.ardeabio.com, and will be archived there for 30 days following the call. Please connect to
Ardeas website several minutes prior to the start of the broadcast to ensure adequate time for any
software download that may be necessary.
About Hyperuricemia and Gout
Gout is a painful and debilitating disease caused by abnormally elevated levels of uric acid in
the blood stream. Approximately 90% of gout patients are considered to be under-excretors of uric
acid, which leads to excessive levels of uric acid in the blood. Our most advanced product
candidate, RDEA594, is a selective inhibitor of URAT1, a transporter in the kidney that regulates
uric acid excretion from the body. . Consequently, increasing renal excretion of uric acid by
moderating URAT transporter activity may provide the most physiologically appropriate treatment
for gout.
About RDEA594 and RDEA684
RDEA594 is our lead product candidate for the treatment of hyperuricemia and gout. RDEA594 is in
Phase 2 development as a single agent and in combination with the approved xanthine oxidase
inhibitor, allopurinol. Over 300 people have safely received RDEA594, either by direct
administration or through administration of RDEA806, its prodrug. We have selected a
next-generation URAT1 inhibitor, RDEA684, as a development candidate and expect to begin a Phase 1
study of RDEA684 in 2010. Based on preclinical results, RDEA684 demonstrates many of the same
positive attributes as RDEA594, but with more than 170-times greater potency against the URAT1
transporter.
About Ardea Biosciences, Inc.
Ardea Biosciences, Inc., of San Diego, California, is a biotechnology company focused on the
development of small-molecule therapeutics for the treatment of gout, cancer, inflammatory diseases
and human immunodeficiency virus (HIV). RDEA594, our lead product candidate for the treatment of
hyperuricemia and gout, is a selective URAT1 transporter inhibitor in Phase 2 clinical development.
Our next-generation URAT1 inhibitor, RDEA684, is currently in preclinical development. RDEA119, a
potent and specific inhibitor of mitogen-activated ERK kinase (MEK) and our lead product candidate
for the treatment of cancer, is being developed under a global license agreement with Bayer
HealthCare. RDEA119 is being evaluated as a single agent in a Phase 1 study in advanced cancer
patients and in a Phase 1/2 study in combination with sorafenib (Nexavar®; Bayer
HealthCare, Onyx Pharmaceuticals) in advanced cancer patients. RDEA119 has also been evaluated for
potential use in inflammatory diseases in a Phase 1 study in normal healthy volunteers. RDEA806,
our lead product candidate for the treatment of HIV, is a non-nucleoside reverse transcriptase
inhibitor (NNRTI) that has successfully completed a Phase 2a study in HIV patients.
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 RDEA594, RDEA684, RDEA119, RDEA806 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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