Amylin Initiates Phase 2B Dose-Ranging Clinical Study of Pramlintide/Metreleptin Combination Treatment in Obesity

07-May-2008

Amylin Pharmaceuticals, Inc. announced the initiation of a Phase 2B clinical study evaluating various dosing combinations of pramlintide, an analog of the natural hormone amylin, and recombinant human leptin (r-metHuLeptin; metreleptin) for the treatment of obesity. The objective of this dose-ranging study is to support dose selection for Phase 3, and to inform the ongoing development of a convenient delivery system for this combination regimen. The six-month, randomized, double-blind, placebo-controlled multi-center study will enroll approximately 600 overweight and obese subjects and is expected to complete in mid-2009.

"There is a tremendous medical need and market demand for a weight loss product that meets both safety and efficacy expectations of patients and physicians, and we believe that our integrated neurohormonal approach to obesity holds great promise for achieving this profile," stated Christian Weyer, M.D., Vice President of Clinical Research, Amylin Pharmaceuticals. "Building upon the positive results of our translational research program published today in PNAS, and the extensive clinical experience with both pramlintide and metreleptin as monotherapies, the newly initiated Phase 2B study will bring us one step closer to our goal of offering obese individuals a safe and effective therapy that results in meaningful weight loss."

The Phase 2B study will include a broad range of overweight and obese subjects (body mass index 27 to 45 kg/m2) and will compare various pramlintide/metreleptin combination regimens with each compound alone and with placebo.

Also, comprehensive preclinical findings of amylin/leptin synergy, along with positive results of a translational Phase 2A clinical study were published online in PNAS, Proceedings of the National Academy of Sciences of the United States of America, in a scientific paper entitled, "Leptin Responsiveness Restored by Amylin Agonism in Diet-Induced Obesity: Evidence from Non-Clinical and Clinical Studies."

Pramlintide is a synthetic analog of amylin, a neurohormone secreted by the pancreas that is known to play a role in the regulation of appetite, food intake and postprandial glucose concentrations. Pramlintide is the active ingredient in SYMLIN(R) (pramlintide acetate) injection, which is indicated for use by patients with type 1 and type 2 diabetes who use mealtime insulin.

Metreleptin (methionyl recombinant leptin; r-metHuLeptin) is an analog of human leptin, a neurohormone secreted by fat cells that plays a fundamental role in the regulation of energy metabolism and body weight. Amylin acquired exclusive rights to the leptin molecular franchise and clinical program in 2006.

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