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genisi

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genisi

Re: DewDiligence post# 63729

Friday, 08/08/2008 2:07:51 AM

Friday, August 08, 2008 2:07:51 AM

Post# of 251852
Ardea Biosciences Presents Phase 2a Antiviral Activity Data for Lead HIV Candidate, RDEA806 at XVII International AIDS Conference

http://investorcenter.ardeabio.com/releasedetail.cfm?ReleaseID=327048

MEXICO CITY and SAN DIEGO, Aug 07, 2008 /PRNewswire-FirstCall via COMTEX News Network/ -- Ardea Biosciences, Inc. (Nasdaq: RDEA) today announced that data was presented from its completed Phase 2a proof-of-concept monotherapy study of RDEA806, the Company's novel investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) for patients with human immunodeficiency virus (HIV), demonstrating robust antiviral activity with a well-tolerated profile. An oral presentation of the data was given today by Dr. Graeme Moyle, Director of HIV Research, Chelsea and Westminster Hospital, during a late breaker session at the XVII International AIDS Conference in Mexico City.

"We are extremely pleased that the final results of the Phase 2a study presented today demonstrate that 800 mg once daily produced similar viral load reductions as 400 mg twice daily, providing final confirmation that RDEA806 works equally well given either once or twice daily. Based on the data to date, we continue to believe that RDEA806 has the potential to be a first-line therapy for the treatment of HIV," said Barry D. Quart, PharmD, Ardea's President and CEO. "We look forward to further evaluating RDEA806 and are on track to begin a Phase 2b study comparing once daily doses of RDEA806 to efavirenz (SUSTIVA(R), Stocrin(R)) in first-line patients receiving background treatment with Truvada(R) (emtricitabine and tenofovir disoproxil fumarate), in the third quarter of this year. A recently completed drug interaction study with RDEA806 and Truvada confirmed the lack of drug-drug interactions between these agents, paving the way for initiation of the Phase 2b study."

The Phase 2a randomized, double-blind, placebo-controlled trial evaluated the antiviral activity, pharmacokinetics, safety and tolerability of once- and twice-daily oral dosing regimens of RDEA806 versus placebo in 48 HIV-positive 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. Results from all four cohorts showed a median reduction in plasma viral load at nadir of 1.8 - 2.0 log copies/mL. There were no serious adverse events, premature discontinuations, clinically relevant ECGs changes or drug-related rash reported in any cohort. The incidence of CNS side effects was similar between drug and placebo. Gastrointestinal side effects were most common, but these effects were generally transient and mild.

The presentation is available on the conference website (http://www.aids2008.org) and on the Company website ( http://www.ardeabio.com) under the title "Antiviral activity of RDEA806, a novel HIV non-nucleoside reverse transcriptase inhibitor, in treatment of naive HIV patients."
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