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Ardea Biosciences Reports Additional Positive Phase 2a Results for Lead HIV Candidate, RDEA806, Demonstrating Up to 1.9 Log Reduction in Plasma Viral Load with Once-Daily Dosing
Date:6/25/2008

itive patients who were naive to antiretroviral treatment. Nine out of 12 patients in each of four cohorts received RDEA806. The primary efficacy end point was the change from baseline in plasma viral load. Top-line results from all four cohorts showed the following:

-- The median reduction in plasma viral load at nadir was 1.9 - 2.1 log copies/ml (placebo adjusted) for all four treatment cohorts.

-- Patients receiving either 800 mg or 1000 mg once daily with the enteric-coated tablet formulation, and patients receiving 400 mg twice daily with the capsule formulation, experienced a 1.8 - 1.9 log median reduction in plasma viral load (adjusted for placebo) on Day 8; the 600 mg capsule formulation given once daily produced a 1.4 log median reduction (adjusted for placebo) at this time point.

-- There were no serious adverse events, ECG-related adverse events, or drug-related rash reported in any cohort. The incidence of CNS side effects was similar between drug and placebo. Administration of the highest dose on an empty stomach showed an increase in gastrointestinal side effects, but these effects were generally transient and mild.

-- There were no premature discontinuations in any cohort.

-- Based on the results generated in this trial, the doses planned for the Phase 2b program will be 600 mg, 800 mg and 1000 mg once daily with the enteric-coated tablet given with or without food.

"We are very pleased to announce the successful completion of the Phase 2a program with RDEA806," said Barry D. Quart, PharmD, Ardea's President and CEO. "Based on the excellent antiviral activity observed with once-daily dosing of the enteric-coated oral formulation, we plan to proceed in the third quarter of this year with a multi-national Phase 2b study comparing 600 mg, 800 mg and 1000 mg once daily doses of RDEA806 to efavirenz (SUSTIVA(R)) in first-line patients receiving background treatment with Truvada(R) (emtricitabine and tenofovir)." '/>"/>

SOURCE Ardea Biosciences, Inc.
Copyright©2008 PR Newswire.
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