Amylin Pharmaceuticals, Inc. announced the initiation of a Phase 2 clinical study of exenatide LAR for type 2 diabetes, the initiation of a Phase 1 clinical study of AC162352 (PYY 3-36) for obesity, and the completion of enrollment of a Phase 2 clinical study of AC137 for obesity.
Exenatide LAR is the long-acting release formulation of exenatide, a compound being developed for the treatment of type 2 diabetes. Studies in 2003 resulted in the selection of a formulation that offers the potential for weekly or monthly dosing. The study currently underway is designed to measure drug concentration in the blood stream over time, following various doses of exenatide LAR. The study will include up to 60 patients with type 2 diabetes. Results are expected in the second half of 2004. Exenatide LAR is being developed through collaborations with Eli Lilly and Company and Alkermes, Inc.
AC162352 (PYY 3-36) is a compound being evaluated for the treatment of obesity. Independent researchers have reported acute reductions in food intake in humans using PYY 3-36. Amylin submitted an Investigational New Drug application for AC162352 to the U.S. Food and Drug Administration in December 2003. The current study is a Phase 1 dose-rising safety study, which is anticipated to include up to 80 healthy volunteers. This is the second obesity clinical program initiated by Amylin in 2004.
Earlier this year the company initiated a Phase 2 study to begin evaluation of AC137 as a potential treatment for obesity. The dose-escalation study for this program, which recently completed enrollment, is designed to evaluate the safety and tolerability of rising doses of AC137 in approximately 200 obese subjects with and without diabetes. Data from this study are expected in the second half of 2004. AC137 is pramlintide, the same compound contained in Symlin, which is being developed by Amylin as a treatment of insulin-dependent diabetes, and is currently under review by the FDA.