Ardea Biosciences to Present Additional Data From Completed Phase 2b Combination Study of Lesinurad (RDEA594) and Allopurinol at the Annual European Congress of Rheumatology

April 25, 2011

SAN DIEGO, April 25, 2011 /PRNewswire/ — Ardea Biosciences, Inc. (Nasdaq: RDEA) today announced that additional data from its completed Phase 2b study (Study 203) evaluating lesinurad in combination with allopurinol in gout patients not adequately responding to allopurinol alone will be presented at the Annual European Congress of Rheumatology hosted by the European League Against Rheumatism (EULAR) on May 26, 2011 in London, UK. The Company will also present additional data from a completed Phase 1b study evaluating the combination of lesinurad and febuxostat (Uloric®, Takeda Pharmaceutical Company Limited; Adenuric®, Ipsen and Menarini) in gout patients, as well as data from a completed preclinical study of lesinurad’s effect on hyperuricemia caused by the commonly used diuretic, hydrochlorothiazide. Lesinurad is Ardea’s lead product candidate for the treatment of hyperuricemia and gout.

Presentation details are as follows:

    Presentation         Title: Efficacy and Safety of Lesinurad (RDEA594),
                         A Novel Uricosuric Agent, Given in Combination with
                         Allopurinol in Allopurinol-Refractory Gout Patients:
                         Randomized, Double-Blind, Placebo-Controlled, Phase
                         2b Study

    Session Title:       Abstract Session - Bone and Crystal Diseases

    Presenter:           Fernando Perez-Ruiz, MD, PhD, Assistant Head,
                         Rheumatology Division, Hospital de Cruces,
                         Viscaya, Spain
    Abstract Number:     OP0111
    Date/Time:           Thursday, May 26, 2011 from 10:15 AM - 11:45 AM BST
    Location:            Room S25

    Presentation Title:  Lesinurad (RDEA594), A Novel Uricosuric Agent,
                         In Combination with Febuxostat Shows Significant
                         Additive Urate Lowering Effects in Gout Patients
                         with 100% Response Achieved For All Combination
                         Dose Regimens
    Session Title:       Poster Session I
    Abstract Number:     THU0026
    Date/Time:           Thursday, May 26, 2011 from 11:45 AM - 1:30 PM BST
    Location:            Poster Area

    Presentation Title:  Lesinurad (RDEA594), A Novel Investigational
                         Uricosuric Agent for Hyperuricemia and Gout,
                         Blocks Transport of Uric Acid Induced by
    Session Title:       Poster Session I
    Abstract Number:     THU0025
    Date/Time:           Thursday, May 26, 2011 from 11:45 AM - 1:30 PM BST
    Location:            Poster Area

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., 6.4 million patients in the European Union and 2.9 million patients in Japan were 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

Our most advanced product candidate for the treatment of hyperuricemia and gout, lesinurad, previously called RDEA594, is an oral, once-daily inhibitor of URAT1, a transporter in the kidney that regulates uric acid excretion from the body. Approximately 90% 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 treatment for gout. In addition, because increasing the excretion of serum uric acid is additive to the effects of drugs that decrease the production of uric acid, such as 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 completed Phase 2 development 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 treatment of hyperuricemia and gout, is a once-daily, oral inhibitor of the URAT1 transporter which has completed Phase 2 clinical development. Our next-generation URAT1 inhibitor program is currently in preclinical development. BAY 86-9766, previously called 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 AG. BAY 86-9766 is currently in a Phase 2 study in patients with hepatocellular carcinoma in combination with sorafenib (Nexavar®; Bayer, Onyx Pharmaceuticals) and a Phase 1/2 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 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.

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SOURCE Ardea Biosciences, Inc.

Source: newswire

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