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Ardea Biosciences Advances Lead Product Candidate for the Treatment of Gout, RDEA594, Into Phase 1 Clinical Trial
Date:8/21/2008

neys, leading to inflammation, the formation of disfiguring nodules (tophi), intermittent attacks of severe pain (acute flares), and kidney damage (nephropathy). While gout is a treatable condition, there are limited treatment options and a number of adverse effects are associated with current therapies. No new therapies have been approved by the FDA for the treatment of hyperuricemia associated with gout in the past 40 years

About RDEA594

RDEA594, our lead product candidate for the treatment of gout, is a major metabolite of RDEA806, our lead non-nucleoside reverse transcriptase inhibitor (NNRTI) in clinical development for the treatment of HIV. RDEA594 does not have antiviral activity and is believed to be responsible for the uric acid-lowering effects observed following administration of RDEA806 to over 100 subjects in Phase 1 and Phase 2 clinical trials. In Phase 1 studies of RDEA806 in normal healthy volunteers, increased urinary excretion of uric acid was observed in the first 24 hours after dosing, with statistically significant, exposure-dependent, decreases in serum uric acid of 35% to 50% observed during multiple dosing out to 14 days.

About RDEA806

RDEA806 is a novel 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; limited pharmacokinetic interactions with other drugs; no reproductive toxicity based on animal studies; and the potential to be readily co-formulated in a single pill with other HIV antiviral drugs, such as Truvada(R) (emtricitabine and tenofovir) from Gilead Sciences, Inc, which is important for patient compliance.

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Related medicine technology :

1. Ardea Biosciences, Inc. Announces Completion of Phase 1 Clinical Trials of Novel Investigational HIV Drug RDEA806
2. Ardea Biosciences, Inc. Presents Results of Phase 1 Studies of RDEA806, a Novel NNRTI for HIV, at 47th ICAAC
3. Ardea Biosciences Lead MEK Inhibitor, RDEA119, to Enter Human Clinical Trials in Advanced Cancer Patients
4. Ardea Biosciences, Inc. Announces New Clinical Development Program Directed Toward the Treatment of Gout
5. Ardea Biosciences Presents Preclinical Data Demonstrating Favorable Resistance Profiles for Non-Nucleoside Reverse Transcriptase Inhibitors for the Treatment of Human Immunodeficiency Virus
6. Ardea Biosciences Reports Positive Phase 2a Results for Lead HIV Candidate, RDEA806, Demonstrating up to 2.0 Log Reduction in Plasma Viral Load
7. Ardea Biosciences Presents Data Demonstrating Favorable Pharmacokinetics and Efficacy for Mitogen-Activated ERK Kinase (MEK) Inhibitors
8. Ardea Biosciences Appoints John W. Beck Chief Financial Officer, Announces Clinical Development Progress and Reports First Quarter 2008 Financial Results
9. Ardea Biosciences Identifies Lead Development Candidate for Gout, RDEA594
10. Ardea Biosciences Presents Preclinical Data on RDEA119 Demonstrating Favorable Anti-Inflammatory Profile for Potential Use in Ulcerative Colitis
11. Ardea Announces Progress with HIV Non-Nucleoside Reverse Transcriptase Inhibitor Program
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