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Ardea Biosciences, Inc. Presents Results of Phase 1 Studies of RDEA806, a Novel NNRTI for HIV, at 47th ICAAC
Date:9/19/2007

- RDEA806 safe and well tolerated in single-dose and multiple-dose studies

up to 14 days - No evidence of CNS disturbances, rash or elevations in lipids, side

effects observed with other NNRTIs - Pharmacokinetics support further investigation with once- and twice-daily

dosing - Preclinical and Phase 1 clinical data indicate a low propensity for

drug-drug interactions

CHICAGO, Sept. 19 /PRNewswire-FirstCall/ -- Ardea Biosciences, Inc. (Pink Sheets: ARDC) today presented the results of Phase 1 single-ascending-dose, multiple-ascending-dose, food-effect and drug-interaction studies of RDEA806, a novel HIV non-nucleoside reverse transcriptase inhibitor (NNRTI), at the 47th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) [Posters A-1429 and A-1430, Poster Session 160, Antiviral Agents]. To view the posters on-line, go to http://www.ardeabio.com.

Two double-blind, placebo-controlled, Phase 1 studies, conducted in 92 healthy adult male volunteers, of which 78 received RDEA806, demonstrated that RDEA806 was safe and well-tolerated at all doses evaluated with no serious adverse events or clinically significant laboratory or ECG abnormalities. After dosing for up to 14 days at up to 1,000 mg per day, there was no evidence of CNS disturbances or rash, side effects that have been observed with other NNRTIs that are currently marketed or in development. Furthermore, plasma cholesterol and triglyceride levels, which have been shown to increase with many HIV drugs, were stable or decreased during RDEA806 dosing.

The systemic exposure of RDEA806 increased linearly from 50 mg to 600 mg under fasted or fed conditions. The terminal half-life of RDEA806 was up to 11 hours after single doses and up to 13 hours following multiple doses. With doses of 300 mg to 500
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SOURCE Ardea Biosciences, Inc.
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