Amylin Pharmaceuticals Initiates Phase 2B Dose-Ranging Clinical Study of Pramlintide/Metreleptin Combination Treatment ...(g/m2) and will compare variouspramlintid...),Health

PNAS Publication

Also today, 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."

"Leptin is a fundamentally important hormone in energy metabolism with a unique role in inducing fat-specific weight loss and in preventing weight loss counterregulation," remarked Steven Smith, M.D., Professor and Assistant Associate Director of Clinical Research, Endocrinology Laboratory at the Pennington Biomedical Research Center. "The intriguing and important findings published today constitute a strong scientific basis for the development of peptide hormone combinations, and provide renewed hope of harnessing the therapeutic potential of leptin as part of an integrated neurohormonal approach to obesity pharmacotherapy."

The scientific studies included in the PNAS publication provide preclinical and clinical evidence that leptin responsiveness is at least partially restored by amylin agonism. In several independent experiments in diet-induced obese rats, co-administration of amylin, together with leptin, resulted in synergistic reductions in food intake (up to 45%) and body weight (up to 15%), effects considerably greater than with leptin or amylin treatment alone. Importantly, weight loss with amylin/leptin treatment was fat-specific, and not accompanied by a reduction in lean mass. Neurohistological studies provided important insights into the neurobiological basis of amylin/leptin synergy. Finally, the translational clinical research confirmed that findings in the non-clinical experiments are
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