SAN DIEGO, CA, Oct 19, 2011 (MARKETWIRE via COMTEX) --

Ardea Biosciences, Inc. (NASDAQ: RDEA) today announced that additional data from the ongoing extension portion of a Phase 2b study (Study 203) of lesinurad, Ardea's lead product candidate for the chronic treatment of gout, in combination with allopurinol in patients who did not achieve target serum urate (sUA) levels on allopurinol therapy alone, will be presented at the 2011 ACR/ARHP Annual Scientific Meeting on Monday, November 7, 2011 in Chicago, IL. The Company will also present combined data from multiple Phase 2b studies evaluating the pharmacokinetics, efficacy and safety profile of lesinurad in patients with mild to moderate renal impairment as well as an oral presentation on biological activity and binding of high affinity URAT1 transporter inhibitors.

Presentation details are as follows: 

Poster Title:       Efficacy and Safety of Lesinurad (RDEA594), A Novel
                    Uricosuric Agent, Given in Combination with Allopurinol
                    in Allopurinol-Refractory Gout Patients: Preliminary
                    Results from the Randomized, Blinded, Placebo-
                    Controlled, Phase 2b Extension Study
Session Title:      Metabolic and Crystal Arthropathies Poster II: Anti-Gout
                    Therapy and Outcome
Poster Number:      1021
Date/Time:          Monday, November 7, 2011 from 9:00 AM - 6:00 PM CST
Location:           McCormick Place Convention Center: Poster Hall


Poster Title:       Pharmacokinetics, Efficacy and Safety of Lesinurad, A
                    Novel URAT1 Inhibitor, in Individuals with Mild to
                    Moderate Renal Impairment
Session Title:      Metabolic and Crystal Arthropathies Poster II: Anti-Gout
                    Therapy and Outcome
Poster Number:      1030
Date/Time:          Monday, November 7, 2011 from 9:00 AM - 6:00 PM CST
Location:           McCormick Place Convention Center: Poster Hall


Presentation Title: Identification of Specific Amino Acids in the Uric Acid
                    Transporter URAT1 Required for Uricosuric-Mediated
                    Inhibition
Session Title:      Plenary Session II - Oral Presentation
Abstract Number:    1592
Date/Time:          Monday, November 7, 2011 from 12:15 PM - 12:30 PM CST
Location:           McCormick Place Convention Center: W 375 C Presentation

About Hyperuricemia and Gout Gout is a painful, debilitating and progressive disease caused by abnormally elevated levels of uric acid in the blood stream. This leads to the deposition of painful, needle-like uric acid crystals in and around the connective tissue of the joints and in the kidneys, resulting in inflammation, the formation of disfiguring nodules, intermittent attacks of severe pain and kidney damage. In addition, evidence suggests that the chronic elevation of uric acid associated with gout, known as hyperuricemia, may also have systemic consequences, including an increased risk for kidney dysfunction and cardiovascular disease.

In 2008, approximately 8.3 million patients in the U.S., 9 million patients in the European Union and 2.9 million patients in Japan had been diagnosed with gout. Gout is the most common form of inflammatory arthritis in men over the age of 40 and represents a significant unmet medical need with limited treatment options.

About Lesinurad Lesinurad is our most advanced product candidate for the chronic treatment of gout. Lesinurad is an oral, once-daily inhibitor of URAT1, a transporter in the kidney that regulates uric acid excretion from the body. Approximately 90 percent of gout patients are considered to be under-excretors of uric acid, and recent studies have shown that defects in renal transporters have been genetically linked to gout. Consequently, increasing renal excretion of uric acid by moderating URAT1 transporter activity may provide the most physiologically appropriate means of reducing sUA levels. In addition, because increasing the excretion of uric acid is additive to the effects of drugs known as xanthine oxidase inhibitors that decrease the production of uric acid, including allopurinol and febuxostat, lesinurad in combination with such drugs has the potential to treat the significant portion of the gout population that is not adequately treated with existing therapies.

Lesinurad has been evaluated as a single agent and in combination with the approved xanthine oxidase inhibitors, allopurinol and febuxostat. Over 500 people have received lesinurad in Phase 1 and 2 clinical trials.

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 serious diseases. Lesinurad, our lead product candidate for the chronic treatment of gout, is a once-daily, oral inhibitor of the URAT1 transporter. We have completed Phase 2b clinical studies of lesinurad and continue to advance the drug in longer term extensions of these studies. In support of our Phase 3 program we are currently advancing lesinurad in a multinational interventional study designed to identify gout patients who can then enroll into our main Phase 3 studies. Our next-generation URAT1 inhibitor, RDEA3170, is currently in Phase 1 clinical development. BAY 86-9766 (RDEA119) is a potent and specific inhibitor of mitogen-activated ERK kinase (MEK) for the treatment of cancer being developed under a global license agreement with Bayer HealthCare. BAY 86-9766 (RDEA119) is currently in a Phase 2 study in patients with hepatocellular carcinoma in combination with sorafenib and a Phase 1/Phase 2 study in patients with advanced pancreatic cancer in combination with gemcitabine.

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 lesinurad, BAY 86-9766 (RDEA119), RDEA3170 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, including collaboration or license agreements. 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. 

Contact:
John Beck
Ardea Biosciences, Inc.
(858) 652-6523
Email Contact

SOURCE: Ardea Biosciences, Inc. 

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