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    FORMULATIONS OF GLUCAGON-LIKE-PEPTIDE-2 (GLP-2) ANALOGUES
    73.
    发明申请
    FORMULATIONS OF GLUCAGON-LIKE-PEPTIDE-2 (GLP-2) ANALOGUES 有权

    公开(公告)号：US20220265551A1

    公开(公告)日：2022-08-25

    申请号：US17276252

    申请日：2019-09-27

    申请人： Zealand Pharma A/S

    发明人： Lise GIEHM ,  Claes MELANDER ,  Eva Horn MØLLER

    IPC分类号： A61K9/08 ,  C07K14/605 ,  A61K47/18 ,  A61K47/22 ,  A61K47/10 ,  A61K38/26 ,  A61K45/06 ,  A61K47/20

    摘要： Liquid formulations of GLP-2 analogues that make them suitable for long term storage as liquids and/or that makes them especially suitable for delivery by a drug delivery device are described. Solid compositions comprising acetate salts of glucagon-like peptide 2 (GLP-2) analogues useful for making the liquid formulations are also described. The development of these liquid formulations is based on the finding that acetate present in the formulation that originates from the GLP-2 analogues has an effect on the viscosity of the formulation, that during long term storage at 2-8° C. of GLP-2 analogues, the concentration dependence for covalent oligomer formation is inversely dependent on increasing concentration of the GLP-2 analogue, and that GLP-2 analogues used in the formulations are not compatible with phosphate buffer commonly used in the prior art to reconstituted powdered or lyophilized GLP-2 compositions.

    GLUCAGON-LIKE-PEPTIDE-2 (GLP-2) ANALOGUES
    76.
    发明申请
    GLUCAGON-LIKE-PEPTIDE-2 (GLP-2) ANALOGUES 有权

    公开(公告)号：US20210309708A1

    公开(公告)日：2021-10-07

    申请号：US17154620

    申请日：2021-01-21

    申请人： Zealand Pharma A/S

    发明人： Bjarne Due LARSEN ,  Yvette Miata PETERSEN

    IPC分类号： C07K14/605 ,  A61K35/54 ,  A61K47/26 ,  A61K9/19 ,  C12N7/00 ,  A61K9/00 ,  A61K38/26 ,  A61K35/74 ,  C12N15/09 ,  C12N15/63

    摘要： GLP-2 analogues are disclosed which comprise one of more substitutions as compared to [hGly2]GLP-2 and which improved biological activity in vivo and/or improved chemical stability, e.g., as assessed in in vitro stability assays. More particularly, preferred GLP-2 analogues disclosed herein comprise substitutions at one or more of positions 8, 16, 24 and/or 28 of the wild-type GLP-2 sequence, optionally in combination with further substitutions at position 2 (as mentioned in the introduction) and one or more of positions 3, 5, 7, 10 and 11, and/or a deletion of one or more of amino acids 31 to 33 and/or the addition of a N-terminal or C-terminal stabilizing peptide sequence. The analogues are particularly useful for the prophylaxis or treatment of stomach and bowel-related disorders and for ameliorating side effects of chemotherapy. Also disclosed are methods and kits for selecting a patient from populations suited for treatment with GLP-2 analogues.