Ardea Presents Preclinical Data on Novel Next Generation Non-Nucleoside Reverse Transcriptase Inhibitors Demonstrating Potent Anti-HIV Activity Against Resistant Viruses Lead NNRTI RDEA806 to begin Phase 2b trial in the second quarter of 2008
MONTREAL and SAN DIEGO, April 14, 2008 -- Ardea Biosciences, Inc. (Nasdaq: RDEA) today announced that preclinical data was presented on the Company's next generation non-nucleoside reverse transcriptase inhibitor (NNRTI) family of compounds demonstrating potent activity against the human-immunodeficiency virus (HIV), including NNRTI- resistant strains, with the potential for improved performance over current NNRTIs. The data were presented at the 21st International Conference on Antiviral Research (ICAR) in Montreal, Quebec, Canada. The compounds in this series are potent against both wild-type and the most common NNRTI-resistant viruses and are more active than efavirenz (Sustiva(R), BMS) and nevirapine (Viramune(R), Boehringer-Ingelheim) against a broad panel of NNRTI-resistant clinical isolates. "Safer, better tolerated NNRTIs that also work against viruses resistant to the most widely used NNRTIs, are needed to expand the armamentarium," said Barry D. Quart, PharmD, Ardea Biosciences' President and CEO. "Our lead NNRTI, RDEA806, has shown the potential to match this profile and we are preparing to progress it into a Phase 2b trial later this quarter. An important part of our business strategy is to progress an additional next generation NNRTI, from the structurally novel series presented today, into Phase 1 later this year." The poster is available on the Company website (http://www.ardeabio.com) under the title, "A Novel NNRTI Class with Potent Anti-HIV Activity against NNRTI-Resistant Viruses." About RDEA806 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 may have important competitive advantages. 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; 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, of San Diego, California, is a biotechnology company focused on the discovery and development of small-molecule therapeutics for the treatment of HIV, cancer and inflammatory diseases, including gout. The Company has two product candidates in clinical development and several others in preclinical development. Ardea's most advanced clinical development candidate is RDEA806, a non-nucleoside reverse transcriptase inhibitor (NNRTI), which is in a Phase 2a study for the treatment of HIV. In addition, the Company is investigating RDEA806 for the treatment of gout. The Company's lead mitogen-activated ERK kinase (MEK) inhibitor, RDEA119, is in a Phase 1 study in advanced cancer patients and is being investigated for the treatment of inflammatory diseases. Ardea also is developing a next-generation NNRTI for HIV and a next-generation MEK inhibitor for both cancer and inflammatory diseases.
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: sufficiency of cash resources and our goals, including the expected properties and benefits of RDEA806, RDEA119, 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 internal development and in-licensing 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.
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