Ardea Biosciences, Inc. Announces New Clinical Development Program Directed Toward the Treatme...(HIV. The Phase 1 program included adoubl...),Health

Date:11/28/2007

HIV. The Phase 1 program included a double-blind, placebo-controlled, multiple-ascending-dose (MAD) study in which 24 healthy volunteers received one of three doses of RDEA806 or placebo for 10-14 days. As reported earlier (http://www.ardeabio.com/publications_posters.html), RDEA806 was safe and well-tolerated at all doses evaluated with no serious adverse events or clinically significant laboratory or ECG abnormalities. Furthermore, a trend toward a reduction in plasma cholesterol and triglyceride levels was reported.

Further analysis of the data from the MAD study showed a statistically significant, exposure-dependent reduction in serum uric acid (SUA). In the dose group that resulted in the highest plasma drug levels (400 mg modified-release capsule twice daily), there was a 50.9% placebo-adjusted reduction in SUA (p < 0.001). The following table summarizes the results by dose group.

Effect of RDEA806 on Serum Uric Acid (SUA) Levels in Phase 1 MAD Study

Mean SUA Level (mg/dL)

Baseline Day 3 Day 10/14[1] Change P Value[2]

Placebo 5.66 6.12 5.78 +3.0 %

300 mg BID [3] 6.19 4.50 4.15 -31.6 % < 0.001

500 mg BID [3] 4.94 2.94 3.06 -38.1 % < 0.001

400 mg MR BID [3][4] 5.25 2.99 2.80 -47.9 % < 0.001

[1] Patients receiving 300 mg and 500 mg BID were dosed for

14 days; patients receiving 400 mg MR BID were dosed for 10 days.

[2] ANCOVA model for the change from baseline versus placebo.

[3] BID = twice daily.

[4] MR= modified-release capsules. This dose group achieved the

highest plasma drug levels.

The magnitude of the uric acid reduction correlates with the individual's baseline uric acid level, such that the higher the baseli
'/>"/>

SOURCE Ardea Biosciences, Inc. Copyright©2007 PR Newswire. All rights reserved

0 GOOD

Page: 1 2 3 4 5 6
Related medicine technology :

1. Ardea Biosciences, Inc. Announces Completion of Phase 1 Clinical Trials of Novel Investigational HIV Drug RDEA806
2. Ardea Biosciences, Inc. Presents Results of Phase 1 Studies of RDEA806, a Novel NNRTI for HIV, at 47th ICAAC
3. Ardea Biosciences Lead MEK Inhibitor, RDEA119, to Enter Human Clinical Trials in Advanced Cancer Patients
4. ImmuneRegen BioSciences, Inc. Demonstrates Radilex(TM) Increases Disease-Fighting White Blood Cells
5. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
6. EDAP Announces Launch of Clinical Study Combining HIFU and Chemotherapy for Localized Aggressive High Risk Prostate Cancer
7. Cephalon Announces Positive Results from a Pivotal Study of FENTORA in Opioid-tolerant Patients with Non-cancer Breakthrough Pain
8. ADVENTRX Announces Fast Track Designation Granted By the FDA For CoFactor For the Treatment of Metastatic Colorectal Cancer
9. DOV Pharmaceutical, Inc. Announces Successful Phase Ib Results for DOV 21,947
10. Phosphagenics Announces Positive Phase 1b Transdermal Insulin Clinical Trial Results
11. Xenomics Announces Implementation of its First Diagnostic Test for Acute Myeloid Leukemia Into Clinical Practice