CARLSBAD, Calif., Sept. 4 Ardea Biosciences,Inc. (Pink Sheets: ARDC) announced today that it has successfully completedPhase 1 single-ascending-dose, multiple-ascending-dose, food-effect, anddrug-interaction studies of RDEA806, a novel HIV non-nucleoside reversetranscriptase inhibitor (NNRTI), in healthy volunteers.
The data from these Phase 1 clinical trials, together with selectpreclinical data, will be discussed in four poster presentations at the 47thAnnual Interscience Conference on Antimicrobial Agents and Chemotherapy(ICAAC), which is being held September 17-20 in Chicago, Illinois. Abstractscan be accessed on the official ICAAC web site at http://www.icaac.org. Theposter titles and presentation details are as follows:
"We are very encouraged by our Phase 1 clinical trial results in healthyvolunteers. Based on these results, we plan to initiate a Phase 2aproof-of-concept study of RDEA806 in HIV-infected patients before the end ofthis year, the results of which may be available by the first quarter of 2008.Assuming positive results, a larger Phase 2b study in HIV-infected patientscould start in the second quarter of 2008," said Barry D. Quart, PharmD,President and CEO. "ICAAC is an international conference where many newtherapeutic innovations and discoveries are first disclosed, and we lookforward to presenting our preclinical and initial clinical data on RDEA806 atthis important meeting."
RDEA806 is a novel non-nucleoside reverse transcriptase inhibitor (NNRTI)for the potential treatment of HIV infection. Based on preclinical andclinical studies to-date, Ardea believes that RDEA806 possesses severalattractive attributes. These include: potent antiviral activity against awide range of HIV viral isolates, including those that are resistant toefavirenz (Sustiva(R), Bristol-Myers Squibb) and other currently availableNNRTIs; a high genetic barrier to resistance; the potential to be administeredin a patient-friendly, oral dosing regimen; limited pharmacokineticinteractions with other drugs; and the ability to be co-formulated with otherHIV antiviral drugs.
About Ardea Biosciences, Inc.
Ardea Biosciences is focused on the discovery and development ofsmall-molecule therapeutics for the treatment of viral diseases, cancer andinflammatory diseases. The Company plans to initiate clinical studies on fourcompounds this year. These include RDEA806, the Company's lead non-nucleosidereverse transcriptase inhibitor (NNRTI) for the treatment of HIV, whichrecently completed Phase 1 clinical trials, RDEA119, a mitogen-activated ERKkinase (MEK) inhibitor for the treatment of cancer and inflammatory diseases,scheduled to enter Phase 1 clinical trials in the second half of 2007, and afollow-on NNRTI and a follow-on MEK inhibitor, both of which are scheduled toenter first-in-human studies in the fourth quarter of 2007.
Statements contained in this press release regarding matters that are nothistorical facts are "forward-looking statements" within the meaning of thePrivate Securities Litigation Reform Act of 1995. Because such statements aresubject to risks and uncertainties, actual results may differ materially fromthose expressed or implied by such forward-looking statements. Suchstatements include, but are not limited to, statements regarding: Ardea'sgoals, including its goal of initiating a Phase 2 study of RDEA806 inHIV-infected patients and initiating clinical studies on three additionalcompounds this year, the expected properties and benefits of its compounds andthe results of clinical and other studies. Risks that contribute to theuncertain nature of the forward-looking statements include: risks related tothe outcomes of preclinical and clinical trials, risks related to regulatoryapprovals, delays in commencement of preclinical and clinical tests, and costsassociated with internal development