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Ardea Biosciences Reports Positive Phase 2a Results for Lead HIV Candidate, RDEA806, Demonstrating up to 2.0 Log Reduction in Plasma Viral Load
Date:3/17/2008

- Company on Track to Initiate Phase 2b in Second Quarter of 2008 -

- Conference Call Tomorrow at 8:00 a.m. Eastern Time -

SAN DIEGO, March 17 /PRNewswire-FirstCall/ -- Ardea Biosciences, Inc. (Nasdaq: RDEA) today announced positive preliminary results from its ongoing Phase 2a proof-of-concept study of RDEA806, its novel investigational non-nucleoside reverse transcriptase inhibitor (NNRTI), in patients with human immunodeficiency virus (HIV).

Preliminary results from the first two of three cohorts demonstrate that the oral dosing regimens tested so far produce robust reductions in plasma viral load and are well tolerated.

"These preliminary data, together with RDEA806's unique activity against resistant HIV in vitro and extensive safety experience, indicate that RDEA806 is a highly potent antiretroviral that warrants further study for both treatment-naive and treatment-experienced HIV patients," said Graeme Moyle, MBBS, MD, Director of HIV Research, Chelsea and Westminster Hospital, who is conducting the Phase 2a study and assisting with the design of the Phase 2b study.

Phase 2a Clinical Trial Design & Preliminary Results

The Phase 2a, randomized, double-blind, placebo-controlled trial is evaluating the antiviral activity, pharmacokinetics, safety and tolerability of RDEA806 versus placebo in 36 HIV-positive patients who are naive to antiretroviral treatment. Nine out of 12 patients in each of three cohorts will receive RDEA806. The primary efficacy endpoint is the change from baseline in plasma viral load. Preliminary results, which include those from the first ten evaluable patients in the 400mg twice daily cohort and the first eight evaluable patients in the 600mg once daily cohort, sh
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SOURCE Ardea Biosciences, Inc.
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