Ardea Biosciences, Inc. Announces Completion of Phase 1 ClinicalTrials of Novel Investigational HIV Drug RDEA806- Preclinical and Phase 1 Data Scheduled for Presentation at 47th ICAAC on September 18-19, 2007 -
CARLSBAD, Calif., September 04, 2007 /PRNewswire-FirstCall/ -- Ardea Biosciences, Inc. announced today that it has successfully completed Phase 1 single-ascending-dose, multiple-ascending-dose, food-effect, and drug-interaction studies of RDEA806, a novel HIV non-nucleoside reverse transcriptase inhibitor (NNRTI), in healthy volunteers.
The data from these Phase 1 clinical trials, together with select preclinical data, will be discussed in four poster presentations at the 47th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), which is being held September 17-20 in Chicago, Illinois. The poster titles and presentation details are as follows:
-- "The Discovery of RDEA806: A Potent New HIV NNRTI in Phase 1 Clinical Trials" will be presented during Poster Session 101 (HIV: New Drugs), Poster Board #299, Abstract #3285, on Tuesday, September 18, 12:15-1:15 PM in Hall D. -- "RDEA806: A Potent NNRTI with Broad Activity Against Resistant Strains of HIV-1 and a High Genetic Barrier to Resistance" will be presented during Poster Session 101 (HIV: New Drugs), Poster Board #300, Abstract #1662, on Tuesday, September 18, 12:15-1:15 PM in Hall D. -- "Safety and Pharmacokinetics of Ascending Single Oral Doses of RDEA806, a Novel HIV NNRTI, in Healthy Volunteers" will be presented during Poster Session 160 (Antiviral Agents), Poster Board #23, Abstract #1609, on Wednesday, September 19, 11:15 AM-12:15 PM in Hall D. -- "RDEA806, a Potent Non-Nucleoside Reverse Transcriptase Inhibitor with Less Potential for Drug-Drug Interactions" will be presented during Poster Session 160 (Antiviral Agents), Poster Board #25, Abstract #3390, on Wednesday, September 19, 11:15 AM-12:15 PM in Hall D.
"We are very encouraged by our Phase 1 clinical trial results in healthy volunteers. Based on these results, we plan to initiate a Phase 2a 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 2b study in HIV-infected patients could start in the second quarter of 2008," said Barry D. Quart, PharmD, President and CEO. "ICAAC is an international conference where many new therapeutic innovations and discoveries are first disclosed, and we look forward to presenting our preclinical and initial clinical data on RDEA806 at this important meeting."
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, including those that are resistant to efavirenz (Sustiva(R), 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.
About Ardea Biosciences, Inc.
Ardea Biosciences is focused on the discovery and development of small-molecule therapeutics for the treatment of viral diseases, cancer and inflammatory diseases. The Company plans to initiate clinical studies on four compounds this year. These include RDEA806, the Company's lead non-nucleoside reverse transcriptase inhibitor (NNRTI) for the treatment of HIV, which recently completed Phase 1 clinical trials, RDEA119, a mitogen-activated ERK kinase (MEK) inhibitor for the treatment of cancer and inflammatory diseases, scheduled to enter Phase 1 clinical trials in the second half of 2007, and a follow-on NNRTI and a follow-on MEK inhibitor, both of which are scheduled to enter first-in-human studies in the fourth quarter of 2007.
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: Ardea's goals, including its goal of initiating a Phase 2 study of RDEA806 in HIV-infected patients and initiating clinical studies on three additional compounds this year, the expected properties and benefits of its compounds and the results of clinical and other studies. Risks that contribute to the uncertain nature of the forward-looking statements include: risks related to the outcomes of preclinical and clinical trials, risks related to regulatory approvals, delays in commencement of preclinical and clinical tests, and costs associated with internal development and in-licensing activities. These and other risks and uncertainties are described more fully in Ardea's most recently filed SEC documents, including its Annual Report on Form 10-K and 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. Ardea undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Posted: September 2007