Referer: http://www.ardeabio.com/about.html Ardea Biosciences Viral - Rationale for Targeting HIV

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Development Pipeline |HIV | Cancer | Inflammatory Diseases

Rationale for Targeting HIV
  • Worldwide, an estimated 39.5 million people are living with HIV1
  • Between 1.04 and 1.85 million people are living with HIV in the U.S.2
  • An estimated 2.2 million people in Europe are living with HIV3
  • Emergence of drug resistance has thwarted global efforts to effectively manage HIV infection4
  • There is a need for safe and convenient drug combinations to improve patient compliance

RDEA806, our lead development candidate for the potential treatment of HIV infection, is a non-nucleoside reverse transcriptase inhibitor (NNRTI). There are three approved NNRTIs, but they have several therapeutic limitations, including the development of HIV strains that are resistant to other drugs within the class; unacceptable adverse side effects; reproductive toxicity, which limits the use of the compounds in women of childbearing potential; and drug-to-drug interactions. Based on preclinical and clinical studies to-date, we believe 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 (Sustivaź, 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. To date, RDEA806 has successfully completed a number of Phase 1 and Phase 2 clinical trials and has been evaluated in over 100 subjects. A Phase 2a proof-of-concept study of RDEA806 was completed in the second quarter of 2008. Results from this study demonstrated an up to 1.9 log reduction in plasma viral load with once-daily dosing of RDEA806. In addition, all dosing regimens tested were well tolerated.

Our second-generation NNRTIs are also directed toward the potential treatment of HIV. Compounds in this series are novel, representing new chemical entities, and are in a different chemical class from RDEA806. Based on early preclinical data, we believe that one or more of these compounds may have the potential to share certain positive attributes of RDEA806, but also appear to have even greater activity against a wide range of drug-resistant viral isolates. Our lead candidate for development in this series of compounds is RDEA427.

For more information regarding these programs please click here to view our most recent company presentation.

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    References:
  1. Global AIDS epidemic continues to grow. New data also show HIV prevention programs getting better results if focused on reaching people most at risk and adapted to changing national epidemics. Geneva, Switzerland: World Health Organization; November 21, 2006.
  2. A glance at the HIV/AIDS epidemic. CDC HIV/AIDS Fact Sheet. Atlanta, GA: Centers for Disease Control and Prevention; January 2007.
  3. HIV/AIDS in Europe: overview. Fact Sheet EURO/14/05. Geneva, Switzerland: World Health Organization Europe; November 28, 2005.
  4. Briefing Note-HIV drug resistance. Geneva, Switzerland: World Health Organization. Report from Conference on Retroviruses and Opportunistic Infections; February 25-28, 2007.