AtheroGenics (AGIX) Reports Positive Preliminary Results from Phase 3 Trial of ANDES

April 14, 2008 7:26 AM EDT

AtheroGenics, Inc. (Nasdaq: AGIX) released topline results from a planned interim analysis of its ongoing ANDES Phase 3 clinical trial of AGI-1067 for the treatment of Type 2 diabetes. ANDES is evaluating two dose levels of AGI-1067 given once daily over six months. The primary efficacy endpoint is changed in hemoglobin A1c (A1c) from baseline compared to placebo in patients with Type 2 diabetes.

The interim analysis of 806 patients who completed three months in the study showed dose-related, statistically significant reductions in A1c. The mean changes for patients in the 150 mg, 75 mg, and placebo arms were 0.5%, 0.3%, and 0.1% respectively, (p < 0.001 for 150 mg versus placebo, p=0.001 for 75 mg versus placebo).

"The ANDES trial is ongoing and we must await final data before drawing firm conclusions," commented Alexander Fleming, M.D., Acting Chief Medical Officer. "We are encouraged by these early results, which show a meaningful reduction in blood sugar for patients with diabetes taking AGI-1067. The interim data also suggest that this three month assessment may not be capturing the full effect of AGI-1067 on A1c reduction, which is the standard clinical measure of blood sugar control."

AtheroGenics, Inc. (AtheroGenics) is a research-based pharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of chronic inflammatory diseases, including diabetes and coronary heart disease. [SM]

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