Ardea Biosciences, Inc. Presents Results of Phase 1 Studies of RDEA806, a Novel NNRTI for HIV, at ... (mg twice daily steady-state mean troughc...)

Ardea Biosciences, Inc. Presents Results of Phase 1 Studies of RDEA806, a Novel NNRTI for HIV, at 47th ICAAC

Date:9/19/2007

mg twice daily, steady-state mean trough concentrations ranged from approximately 150 -- 300 ng/ml, which are well above the EC50 (concentration required for 50% inhibition of viral replication) of RDEA806 (EC50 = 1.67 ng/ml).

Evaluation of the drug-drug interaction liability, in vitro and in vivo, demonstrated that RDEA806 is unlikely to be an inducer or inhibitor of major P450 enzymes or be affected by CYP3A4 inhibitors. When given together with ritonavir, an HIV protease inhibitor and potent inhibitor of CYP3A4, plasma levels of RDEA806 were not significantly altered. These data support preclinical data that RDEA806 may have a reduced potential for drug-drug interactions, which could ultimately lead to a safer and more convenient treatment option for patients and physicians.

"We recognize the need for new HIV drugs that demonstrate potent antiviral activity against a wide range of viral isolates, including those that are resistant to currently available NNRTIs, and that show improved safety, tolerability and reduced potential for drug-drug interactions. Yesterday's presentation of the broad spectrum of antiviral activity of RDEA806 demonstrated its in vitro activity against the majority of HIV strains carrying key reverse transcriptase mutations, including coverage of the 10 most prevalent strains of HIV found in patients failing therapy with efavirenz, marketed as Sustiva(R) by Bristol-Myers Squibb*. Based on this very favorable preclinical profile, the excellent tolerability and the high levels of exposure obtained with oral dosing in Phase 1 studies, we are moving forward to conduct a Phase 2a proof-of-concept study in HIV-infected patients, which we plan to initiate before the end of this year. The terminal half-life of up to 13 hours also gives us the opportunity to evaluate once-daily dosing in Phase 2a," said Barry D. Quart, PharmD, President and CEO.

About RDEA806

RDEA806 is a novel non-nucleoside reverse transcriptase inhibitor (
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