Ardea Biosciences Presents Phase 2a Antiviral Activity Data for Lead HIV Candidate, RDEA806 at XVII International AIDS Conference
MEXICO CITY and SAN DIEGO, August 07, 2008 /PRNewswire-FirstCall/ -- Ardea Biosciences, Inc. 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.
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, we believe that RDEA806 may have important competitive advantages compared to currently available NNRTIs. These include the potential for potent antiviral activity against a wide range of HIV viral isolates, including those that are resistant to efavirenz (Sustiva(R)) and other currently available NNRTIs; a high genetic barrier to resistance; no reproductive toxicity based on animal studies; 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.
About Ardea Biosciences, Inc.
Ardea Biosciences, Inc., of San Diego, California, is a biotechnology company focused on the discovery and development of small-molecule therapeutics for the treatment of HIV, gout, cancer and inflammatory diseases. We have four product candidates in clinical trials and others in preclinical development and discovery. Our most advanced product candidate is RDEA806, an NNRTI, which has successfully completed a Phase 2a study for the treatment of patients with HIV. We have evaluated our second-generation NNRTI for the treatment of HIV, RDEA427, in a human micro-dose pharmacokinetic study and have selected it for clinical development. RDEA594, our lead product candidate for the treatment of gout, is in preclinical development. We are currently evaluating our lead MEK inhibitor, RDEA119, in a Phase 1 study in advanced cancer patients and have completed a Phase 1 study in normal healthy volunteers as a precursor to trials in patients with inflammatory diseases. Lastly, we have evaluated our second-generation MEK inhibitor for the treatment of cancer and inflammatory diseases, RDEA436, in a human micro-dose pharmacokinetic study and have selected it for clinical development.
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding our goals, including the expected properties and benefits of RDEA806, RDEA427, RDEA594, RDEA119, RDEA436 and our other compounds and the results of preclinical, clinical and other studies. Risks that contribute to the uncertain nature of the forward-looking statements include: risks related to the outcome of preclinical and clinical studies, risks related to regulatory approvals, delays in commencement of preclinical and clinical studies, and costs associated with our drug discovery and development programs and business development activities. These and other risks and uncertainties are described more fully in our most recently filed SEC documents, including our Annual Report on Form 10-K and our Quarterly Reports on Form 10-Q, under the headings "Risk Factors." All forward-looking statements contained in this press release speak only as of the date on which they were made. We undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Posted: August 2008