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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

owed the following:

-- Patients receiving 400mg twice daily had a 2.0 log placebo-adjusted

mean reduction in plasma viral load.

-- Patients receiving 600 mg once daily had a 1.7 log placebo-adjusted

mean reduction in plasma viral load.

-- There were no serious adverse events reported in either cohort.

-- There were no ECG-related adverse events reported in either cohort.

-- There were no discontinuations in either cohort.

-- None of the typical side effects associated with other NNRTIs were

reported in either cohort, such as drug-related rash or abnormal

dreams.

-- The percentage of patients with adverse events that were possibly

drug-related was lower in patients receiving drug than in those

receiving placebo.

A recently conducted single-dose human bioavailability study of a new enteric-coated tablet formulation of RDEA806 demonstrated increased trough plasma concentrations after 24 hours and greater flexibility in dosing, with the potential for dosing with or without meals. The 80% drug loading in these tablets also improves our ability to co-formulate RDEA806 with other antivirals. The Company plans to evaluate this improved formulation at a dose of 800 mg once daily in a third cohort of its Phase 2a study and advance this formulation into its planned Phase 2b study.

"The viral load reductions observed with RDEA806 are among the largest observed in short-term monotherapy studies of an HIV antiviral, including those of other marketed or investigational NNRTIs and raltegravir (ISENTRESS(TM); Merck)," said Barry D. Quart, PharmD, Ardea's President and CEO. "Based on these positive results, together with the recent successful completion of our new formulation and three-month toxicology studies, we plan to initiate a multi-national Phase 2b study comparing RDEA806 to efavirenz (SUSTIVA(R); Bristol-Myers Squibb) in first-line patients in the second quar
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SOURCE Ardea Biosciences, Inc.
Copyright©2008 PR Newswire.
All rights reserved

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