Possible New Diabetes Drug Succinobucol Meets Main Goal

AtheroGenics, Inc, a pharmaceutical company focused on the treatment of chronic inflammatory diseases, today announced top-line results from its ANDES Phase 3 clinical trial of AGI-1067 (succinobucol) for the treatment of Type 2 diabetes demonstrating that both doses (75mg and 150mg) of AGI-1067 met the primary efficacy endpoint of the reduction in A1c versus placebo at the end of the study’s six month dosing regimen. "We are pleased that the ANDES trial met the primary endpoint and showed a dose response in reducing A1c. Based on the results of this successful trial, AtheroGenics intends to rapidly move forward with development of AGI-1067," said Russell M. Medford, M.D., Ph.D., President and Chief Executive Officer of AtheroGenics. "We believe that AGI-1067, through its unique mechanism of action, could become the first diabetes treatment with demonstrated cardiovascular safety, and with the potential to reduce cardiovascular hard events including cardiovascular death, heart attack and stroke, as reported from the 6,144 patient Phase 3 ARISE trial, which concluded in 2007."

ANDES, an international, double-blind trial, showed a dose-dependent, statistically significant drop in A1c of 0.6% and 0.4% in the 150mg and 75mg arms, respectively, at 6 months, compared to baseline (p < 0.001 for 150 mg versus placebo, p = 0.016 for 75 mg versus placebo). The placebo group decreased 0.2% from baseline.

In the trial, a regional variation was observed in the placebo arm. Eastern Europe showed a significant decrease of 0.5% for A1c in the placebo arm versus baseline. The other study regions showed an increase of 0.1% in A1c in the placebo arm versus baseline. Importantly, A1c reductions in both AGI-1067 treatment arms were similar across all of the regions in the study. The study analysis plan was prospectively designed to detect and analyze the effect of regional differences.

Based on a preliminary review of the safety data, AGI-1067 was well-tolerated and was not associated with weight gain or hypoglycemia in either of the treatment groups. There was no difference in discontinuations between the groups receiving active drug and placebo.

The Company also announced today that it has developed a patient identification tool to screen for the small number of patients who are potentially at risk for adverse hepatic effects that have been observed during treatment with AGI-1067. The tool has performed well at identifying at-risk diabetes patients across all doses used in the ARISE and ANDES trials.

The data represent findings from a multinational, double-blind, placebo-controlled, dose-finding study of patients with Type 2 diabetes (ages 18-75) who were on one or no other oral anti-diabetes therapies and whose A1c level was greater than or equal to 7.5% and less than or equal to 10.5% and completed the study. A total of 999 patients were enrolled in the ANDES study, including 887 in the current three-arm protocol. The trial included approximately 150 clinical sites in the United States, South Africa, India and Eastern Europe.

AGI-1067 is a novel oral drug candidate with demonstrated anti-inflammatory and antioxidant properties. AGI-1067 works by selectively inhibiting signaling pathways that are activated in response to oxidative stress and pro-inflammatory stimuli. Oxidative stress and inflammation have been implicated as playing a key role in the pathogenesis of insulin resistance and diabetes.
News Release

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