Glp-1 analog fusion protein formulations

C - Chemistry – Metallurgy – 07 – K

Patent

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Details

C07K 14/50 (2006.01) A61K 38/00 (2006.01) A61K 38/26 (2006.01) A61P 3/10 (2006.01) C07K 14/435 (2006.01) C07K 14/605 (2006.01) C12N 15/62 (2006.01)

Patent

CA 2589647

The invention provides a stable solution formulation comprising a GLP-1-Fc fusion at a pH between about pH 6 and about pH 8.5. analogs fused to specific IgG4-Fc derivatives. These formulations provide unexpected and considerably greater chemical stability than when compared to GLP-1-Fc fusions at a pH outside the described ranges. The formulations comprising a GLP-1-Fc fusion are useful in treating diabetes, obesity, irritable bowel syndrome and other conditions that would be benefited by lowering plasma glucose, inhibiting gastric and/or intestinal motility and inhibiting gastric and/or intestinal emptying, or inhibiting food intake.

L'invention concerne une préparation sous forme de solution stable, comprenant une fusion GLP-1-Fc, à un pH compris entre 6 et 8,5 environ, ainsi que des produits analogues liés par fusion à des dérivés IgG4-Fc spécifiques. Ces préparations présentent une stabilité chimique sensiblement supérieure à celle de fusions GLP-1-Fc à un pH situé en dehors des marges décrites. Les préparations comprenant une fusion GLP-1-Fc sont utiles pour le traitement du diabète, de l'obésité, du syndrome du côlon irritable et d'autres maladies pouvant être traitées par une réduction de la glycémie plasmatique, une inhibition de la mobilité gastrique et/ou intestinale et une inhibition de la vidange gastrique et/ou intestinale, ou une inhibition de la prise d'aliments.

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