Preliminary results from the first two of three cohorts demonstrate that the oral dosing regimens tested so far produce robust reductions in plasma viral load and are well tolerated. The trial is evaluating the antiviral activity, pharmacokinetics, safety and tolerability of RDEA806 versus placebo in 36 HIV-positive patients who are naive to antiretroviral treatment.
Barry Quart, Ardea’s president and CEO, said: “The viral load reductions observed with RDEA806 are among the largest observed in short-term monotherapy studies of an human immunodeficiency virus (HIV) antiviral, including those of other marketed or investigational non-nucleoside reverse transcriptase inhibitor’s (NNRTIs) and raltegravir (Isentress; Merck). Based on these positive results, together with the recent successful completion of our new formulation and three-month toxicology studies, we plan to initiate a multi-national Phase IIb study comparing RDEA806 to efavirenz (Sustiva; Bristol-Myers Squibb) in first-line patients in the second quarter of 2008.”