Amylin's Exenatide generates positive results Phase III studies

Exenatide (synthetic exendin-4), from Amylin pharmaceuticals, has produced statistically significant, dose-dependent reductions in the glucose control endpoint in a seven-month Phase III pivotal study in people with type 2 diabetes failing to achieve target blood glucose levels with sulfonylurea alone.

Reductions in average blood glucose were similar to reductions observed in the first exenatide pivotal study announced in August 2003. At the end of the study, 41% of subjects completing the study on the highest dose of exenatide (10g twice daily) reduced their hemoglobin A1c (A1C) levels to less than or equal to 7%. A1C is a measure that reflects average glucose levels over the prior three to four month period. The subjects receiving the highest dose of exenatide also showed statistically significant reductions in body weight.

This is the second of three pivotal phase 3 studies of exenatide, the first in a new class of compounds known as incretin mimetics, which is being developed as a potential treatment for type 2 diabetes. Results from these three studies will form the basis of a planned submission to the FDA, currently anticipated in mid-2004. The companies are on track to report the results from the remaining pivotal trial before the end of the year.

Exenatide is being investigated for its potential to address important unmet medical needs of many people with type 2 diabetes. Clinical trials suggest that exenatide treatment decreases blood glucose toward target levels and is associated with weight loss. The effects on glucose control seen with exenatide treatment are likely due to several actions that are similar to those of the naturally occurring incretin hormone glucagon-like peptide-1 (GLP-1). These actions include stimulating the body's ability to produce insulin in response to elevated levels of blood glucose, inhibiting the release of glucagon following meals and slowing the rate at which nutrients are absorbed into the bloodstream. In animal studies exenatide administration resulted in preservation and formation of new beta cells the insulin-producing cells in the pancreas, which fail as type 2 diabetes progresses.

Diabetes -- The Need for New Treatments

Diabetes affects an estimated 194m adults worldwide and more than 17m in the United States. Approximately 90-95% of those affected have type 2 diabetes, in which either the body does not produce enough insulin or the cells in the body do not respond normally to the insulin. According to the US Center for Disease Control's National Health and Examination Survey, 57% of diabetes patients do not achieve target A1C levels with their current treatment regimen and approximately 41% have A1Cs above 8%. According to the ADA, patients with A1Cs above target are more likely to develop diabetes-related complications, such as kidney disease, blindness and heart disease.