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news.Ardea Biosciences has successfully completed Phase I trials of its investigational HIV drug, which the company said showed potent antiviral activity.
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The trial involved single-ascending-dose, multiple-ascending-dose, food-effect, and drug-interaction studies evaluating RDEA806 is a novel non-nucleoside reverse transcriptase inhibitor (NNRTI) for the potential treatment of HIV infection. Based on preclinical and clinical studies to date, Ardea believes that RDEA806 possesses several attractive attributes.
These include: potent antiviral activity against a wide range of HIV viral isolates; the potential to be administered in a patient-friendly, oral dosing regimen; limited pharmacokinetic interactions with other drugs; and the ability to be co-formulated with other HIV antiviral drugs.
“We are very encouraged by our Phase I clinical trial results in healthy volunteers. Based on these results, we plan to initiate a phase IIa proof-of-concept study of RDEA806 in HIV-infected patients before the end of this year, the results of which may be available by the first quarter of 2008. Assuming positive results, a larger phase IIb study in HIV-infected patients could start in the second quarter of 2008,” said Barry Quart, president and CEO of Ardea.