AMYLIN EXPANDS OBESITY CLINICAL PROGRAM

Amylin Pharmaceuticals has presented Phase II data on pramlintide and announced an extensive program of clinical trials that will assess the safety and efficacy of multiple neurohormones used in combination to treat obesity.

This integrated approach to obesity therapy is based on extensive clinical experience with the analog of the human hormone, amylin, called pramlintide, and preclinical data combining neurohormones. Results presented from a Phase II extension study demonstrate that patients completing 52 weeks of pramlintide therapy experienced a 7 to 8 percent mean body weight reduction (depending on dose) compared with a 1 percent reduction in patients receiving placebo. Also, preclinical data were presented revealing novel, additive and synergistic weight loss effects when amylin is used in combination with other neurohormones.

Four of the clinical studies will be conducted using pramlintide in combination with Leptin, PYY 3-36, Leptin with PYY 3-36 and other approved oral antiobesity agents. The fifth study will evaluate an amylin mimetic designed to have enhanced antiobesity properties. The company has filed an investigational new drug application with the FDA for pramlintide.