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Amylin Pharmaceuticals Initiates Phase 2B Dose-Ranging Clinical Study of Pramlintide/Metreleptin Combination Treatment in Obesity
Date:5/5/2008

Preclinical findings of amylin/leptin synergy and translational Phase 2A clinical results published online today in Proceedings of the National

Academy of Sciences of the United States of America

SAN DIEGO, May 5 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) today 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 k
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SOURCE Amylin Pharmaceuticals, Inc.
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