Company to Host Conference Call and Webcast on July 31, 2008 at 9 a.m. EDT
AtheroGenics, Inc. (NASDAQ: AGIX), 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 glycosylated hemoglobin (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. AtheroGenics will continue to
analyze the trial data, including the impact 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. One patient in the
150mg arm and two patients in the 75mg arm had unexplained liver enzyme
elevations of greater than five times the upper limit of normal. The liver
enzyme elevations either have resolved or are resolving.
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.