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DewDiligence

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Re: genisi post# 65195

Monday, 10/27/2008 3:45:39 PM

Monday, October 27, 2008 3:45:39 PM

Post# of 252642
RDEA Advances RDEA806 to Phase-2b in HIV

[RDEA806 is one of the contenders to supersede Sustiva as the sole non-nuke in a 3-drug cocktail including Truvada. (IDX899 from IDIX is another contender for this slot.) The phase-2b trial will test RDEA806 at 600mg, 800mg, and 1000mg qD vs Sustiva as addends to backbone treatment with Truvada in treatment-naïve patients. Please see #msg-31380545 for a brief write-up on the RDEA806 and IDX899 data presented at the recent AIDS conference in Mexico City.]

http://biz.yahoo.com/bw/081027/20081027005292.html

›Ardea Biosciences Presents Additional Phase 2a and Preclinical Data on its Lead HIV Product Candidate, RDEA806, at the 48th Annual ICAAC/IDSA 46th Annual Meeting

Monday October 27, 8:00 am ET

SAN DIEGO--(BUSINESS WIRE)--Ardea Biosciences, Inc. (Nasdaq: RDEA ) announced today that additional data from a Phase 2a monotherapy study of RDEA806, our lead non-nucleoside reverse transcriptase inhibitor (NNRTI) in development for the treatment of human immunodeficiency virus (HIV), were presented at the 48th Annual ICAAC/IDSA 46th Annual Meeting in Washington, DC.

Dr. Graeme Moyle, Director of HIV Research, Chelsea and Westminster Hospital, gave an oral presentation showing that in the Phase 2a study, RDEA806 demonstrated robust antiviral activity with a well-tolerated profile and confirmed a low potential for drug interactions. Data from the study also showed that 800mg of RDEA806 administered once daily produced similar viral load reductions as 400mg of RDEA806 administered twice daily, supporting initiation of a Phase 2b study using once daily doses of RDEA806. In addition, Dr. Moyle presented preliminary data from a Phase 1 drug-drug interaction study of RDEA806 and Truvada® (Gilead Sciences) showing no interaction with either of its components (emtricitabine or tenofovir disoproxil fumarate).

Ardea recently received regulatory approval from the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom to conduct a Phase 2b study comparing RDEA806 to efavirenz (SUSTIVA®/Stocrin®, Bristol-Myers Squibb/Merck) in anti-retroviral treatment of naïve patients without transmitted resistance, receiving background treatment with Truvada.

In addition, Dr. Anneke Raney, director, virology, presented preclinical virology data (poster H-1222) showing RDEA806 has a high genetic barrier to resistance and limited cross-resistance to other NNRTIs [as does IDX899]. Consistent with these in vitro data, no genotypic or phenotypic changes were observed during the Phase 2a study following one week of monotherapy with RDEA806.

“We look forward to initiating the Phase 2b study of RDEA806, an important step forward in the development of this product candidate for the treatment of HIV-infected patients,” commented Barry D. Quart, PharmD, Ardea’s president and chief executive officer.

The presentation and poster are available on the Company website (http://www.ardeabio.com) under the titles, “RDEA806, a Novel Non-Nucleoside Reverse Transcriptase Inhibitor, Shows Positive Outcome in Treatment of Naïve HIV Patients,” and “Resistance to RDEA806 Requires Multiple Mutations Which Have Limited Cross-Resistance to Other NNRTI’s,” respectively.

About RDEA806

RDEA806 is a novel NNRTI for the potential treatment of HIV infection. Based on preclinical and clinical studies to-date, we believe that RDEA806 may have important competitive advantages compared to currently available NNRTIs. These include the potential for potent antiviral activity against a wide range of HIV viral isolates, including those that are resistant to efavirenz and other currently available NNRTIs; a high genetic barrier to resistance; no reproductive toxicity based on animal studies; 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.‹


<font size=3><font color=red> “The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”

“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”

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