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Animal reproductive toxicity studies recently completed with RDEA806 havedemonstrated no effects on male or female fertility or on early embryonicdevelopment at all tested doses. These results are in contrast to the fetalmalformations reported in other NNRTI animal reproductive toxicity studies.
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Exploratory human testing (Phase 0) of RDEA427 was recently completed inwhich micro-doses of the compound were administered to healthy volunteers.Preliminary pharmacokinetic data from this study, produced by Vitalea Science,Inc. using Accelerator Mass Spectrometry (AMS) technology, demonstrated thatRDEA427 has a half-life of approximately 40 hours, which could permit oncedaily oral dosing.
"The ability to use RDEA806 in women, without the risk of birth defects,is a major advantage over the current first-line NNRTI. Women make up 26% ofHIV/AIDS diagnosed patients in the United States, and an even larger percentof infected patients worldwide. These preclinical data for RDEA806 furtherstrengthen its impressive product profile," said Barry D. Quart, PharmD, ArdeaBiosciences' President and CEO. "In addition, the excellent preclinicalproperties of RDEA427 and its long half-life in humans make it the perfectcandidate to progress into clinical testing. Developing both RDEA806 andRDEA427 in tandem is consistent with our business strategy of keeping Ardea'spipeline full of novel compounds in areas that are underserved by currenttreatment options. We are on track to begin a Phase 1 trial with RDEA427 laterthis year, and expect to initiate a Phase 2b trial with RDEA806 in the thirdquarter of this year."
About RDEA806 and RDEA427
RDEA806 and RDEA427 are novel, structurally different NNRTIs for thepotential treatment of HIV infection. Based on preclinical and clinicalstudies to-date, Ardea believes that RDEA806 and RDEA427 may have importantcompetitive advantages. These include: the potential for potent antiviralactivity against a wide range of HIV viral isolates, including those that areresistant to efavirenz (Sustiva(R), Bristol-Myers Squibb); a high geneticbarrier 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. RDEA806reproductive toxicity data indicates that future studies, including Ardea'splanned Phase 2b trial, would likely include women of child-bearing age inanti-retroviral naive HIV-infected patients.
About Ardea Biosciences
Ardea Biosciences, Inc., of San Diego, California, is a biotechnologycompany focused on the discovery and development of small-moleculetherapeutics for the treatment of HIV, cancer and inflammatory diseases,including gout. We have four drug candidates in clinical trials and others inpreclinical development and discovery. Our most advanced development candidateis RDEA806, a non-nucleoside reverse transcriptase inhibitor (NNRTI), which isin a Phase 2a study for the treatment of HIV. We have evaluated oursecond-generation NNRTI for the treatment of HIV, RDEA427, in a humanmicro-dose pharmacokinetic study and have selected it as a developmentcandidate. RDEA594, our lead development candidate for the treatment of gout,is in preclinical development and is believed to be an inhibitor of the URAT1transporter in the kidney, which is responsible for regulation of uric acidlevels. We are evaluating our lead MEK inhibitor, RDEA119, in a Phase 1 studyin a
