ARISE Trials Shows Promising Results for Diabetes
Atherogenics reported positive results from a phase III trial of succinobucol (AGI-1067), an antioxidant oral vascular cell adhesion molecule-1 (VCAM-1) gene expression inhibitor, for the treatment of diabetes and coronary heart disease. This trial, dubbed ARISE (Aggressive Reduction of Inflammation Stops Events), enrolled over 6,000 subjects internationally. Results were reported at the European Society of Cardiology Congress 2007.
Subjects received AGI-1067 or placebo both in conjunction with standard of care. After 12 months of treatment, AGI-1067 significantly lowered levels of glycated hemoglobin A1c, a measure of glycemic control, in subjects with and without diabetes. In addition, the data showed a 59% reduction in the development of new onset diabetes in subjects with impaired fasting glucose (p < 0.0001). ).
In the subjects with diabetes, AGI-1067 showed a 22% reduction in hard cardiovascular events of cardiovascular death, cardiac arrest, myocardial infarction and stroke (p=0.062). Additional phase III trials are currently underway.
In December 2005, AstraZeneca and AtheroGenics signed a $1 billion deal to co-developement and marketwith AGI-1067. However, in April 2007, AstraZeneca terminated the agreement due to initial negative preminary results of the ARISE study for the treatment of heart disease. After initialing failing to meet specific endpoints in the ARISE study for the treatment of heart disease, Atherogeneics stated in May, that the company plans to continue to develop the product for diabetes.