Ardea Biosciences Presents Preclinical Data Demonstrating Favorable Resistance Profiles for Non-Nucleoside Reverse Transcriptase Inhibitors for the Treatment of Human Immunodeficiency Virus
BOSTON and CARLSBAD, Calif., February 07, 2008 /PRNewswire-FirstCall/ -- Ardea Biosciences, Inc. today announced that data was presented demonstrating the potent activity of the Company's non-nucleoside reverse transcriptase inhibitor (NNRTI) family of compounds against the human-immunodeficiency virus (HIV), the known causative agent of AIDS, including NNRTI-resistant strains.
The data was presented at the 15th Annual Conference on Retroviruses and Opportunistic Infections (CROI) in Boston.
The data showed that Ardea's lead NNRTI candidate, RDEA806, is a potent inhibitor of HIV, including the most common efavirenz resistant viruses. Oral dosing with RDEA806 achieves trough levels in humans that average at least 10-fold higher than the serum-adjusted EC50.
"This level of exposure over the concentration of drug needed to inhibit replication of the virus by 50% supports the potential for promising antiviral activity of our drug in HIV-infected patients who are naive to antiretroviral therapy," said Barry D. Quart, PharmD, Ardea's President and CEO. "NNRTIs are a critical component of current HIV therapy; however, there is an unmet need for safer, better tolerated NNRTIs that also work against viruses resistant to the most widely used NNRTIs."
The posters are available on the conference website (http://www.retroconference.org) and on the Company website (http://www.ardeabio.com) under the titles "An IQ Assessment of RDEA806, A Potent NNRTI with an Excellent Activity Profile in the Presence of Human Serum Proteins" and "RDEA427 and RDEA640 are Novel NNRTIs with Potent Anti-HIV Activity against NNRTI-Resistance Viruses."
The Company previously presented Phase 1 data demonstrating the favorable safety profile of RDEA806. No evidence of CNS toxicity or rash, which are common with other NNRTIs, were observed in 74 subjects receiving RDEA806. A Phase 2a trial with this compound is currently enrolling with data expected in the first quarter of this year. The company's follow-on candidate, RDEA427 also has excellent metabolic stability and broad activity against resistant viruses. Ardea plans to report preliminary human data on this candidate in the first quarter of this year as well.
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 properties. These include: potential for potent antiviral activity against a wide range of HIV viral isolates, including those that are resistant to efavirenz (Sustiva(R), Bristol-Myers Squibb); 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 Carlsbad, California is a biotechnology company focused on the discovery and development of small-molecule therapeutics in virology, oncology and inflammation. 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 also investigating RDEA806 for the treatment of gout. In oncology, the Company is investigating a mitogen-activated ERK kinase (MEK) inhibitor, RDEA119, in a Phase 1 study in advanced cancer patients. 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: Ardea's goals, including the expected properties and benefits of RDEA806, RDEA427, RDEA640 and RDEA119 and its other 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 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 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.
CONTACT: Edie DeVine of WeissComm Partners, +1-415-946-1081, for ArdeaBiosciences, Inc.
Ticker Symbol: (NASDAQ-NMS:RDEA)
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Posted: February 2008