QualityStocks.net News – AtheroGenics Inc. (AGIX) Announces Clinical Trial Results for Treatment of Type 2 Diabetes

We would like to highlight AtheroGenics Inc. (NASDAQ: AGIX). The company is focused on the discovery, development and commercialization of novel drugs for the treatment of chronic inflammatory diseases, including diabetes and coronary heart disease (atherosclerosis). AtheroGenics has completed patient enrollment in ANDES (AGI-1067 as a Novel Anti-Diabetic Agent Evaluation Study), a Phase III clinical trial evaluating its oral anti-inflammatory and antioxidant lead candidate, AGI-1067, in patients with diabetes.

In the Company’s news today,

AtheroGenics Inc. announced its “topline” results from an interim analysis of its ANDES Phase 3 clinical trial of AGI-1067, for the treatment of Type 2 diabetes, administered once daily for the duration of six months. According to the press release, the primary efficacy endpoint is changed in hemoglobin A1c (A1c) from baseline compared to placebo in patients with Type 2 diabetes.

For three months, 806 patients took part in the study, showing dose-related, statistically significant reductions in A1c. For patients receiving 150 mg, 75 mg and a placebo, arms were 0.5 percent, 0.3 percent, and 0.1 percent, respectively.

“The ANDES trial is ongoing and we must await final data before drawing firm conclusions,” Alexander Fleming, M.D., acting chief medical officer stated in the press release. “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.”

Russell M. Medford, M.D., Ph.D., president and CEO of AtheroGenics, said the results support the company’s belief that AGI-1067 may be the new therapeutic approach for diabetes patients. “We believe these results are sufficiently promising to allow for the planning of a second registration study. We plan to work with the FDA to gain their concurrence on the design of the next study,” Dr. Medford stated.

A preliminary review of the data shows AGI-1067 was “well-tolerated.” The analysis showed no difference in discontinuations of groups receiving the drug and groups receiving the placebo. While one case of unexplained elevated liver enzymes was recorded in each arm, the elevations were “moderate” without increases in bilirubin; because the number of the incidents was so small, no conclusions are related to AGI-1067’s affect on the liver in the ANDES study. An independent Data Safety and Monitoring Board reviewed the data from the clinical trial and recommended that the trial continue to completion.

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