Ardea Biosciences Initiates Clinical Trial For NNRTI For HIV
Ardea Bioscience announced that the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom has authorized a Phase 2a clinical trial evaluating RDEA806, a novel non-nucleoside reverse transcriptase inhibitor (NNRTI), in patients with human immunodeficiency virus (HIV), the causative agent of AIDS.
"There is a clear unmet need for new NNRTIs that have the potential for a lower incidence of neuropsychiatric adverse effects, a high barrier to resistance, activity against resistant strains and the ability to be combined with other therapeutic agents," said Barry Quart, PharmD, President and CEO of Ardea Biosciences. "We believe that RDEA806 has the potential to offer a new option for patients with HIV and are excited to move this novel compound into Phase 2 clinical testing. We expect to obtain results from this trial in the first quarter of 2008."
The Phase 2a randomized, double-blind, proof-of-concept trial will be conducted in multiple European academic medical centers. The trial will evaluate the antiviral activity, pharmacokinetics, safety and tolerability of once daily and twice daily dose regimens of RDEA806 versus placebo in HIV-1 positive patients who are naive to antiretroviral treatment. The primary efficacy endpoint is the change from baseline in plasma viral load.
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 properties. These include: potential for potent antiviral activity against a wide range of HIV viral isolates, including those that are resistant to efavirenz (Sustiva, Bristol-Myers Squibb) and other currently available NNRTIs; a high genetic barrier to resistance; 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.