Deprecated: The each() function is deprecated. This message will be suppressed on further calls in /home/zhenxiangba/zhenxiangba.com/public_html/phproxy-improved-master/index.php on line 456
NZ764889B2 - Composition for treating diabetes mellitus comprising insulin and a GLP-1/glucagon dual agonist - Google Patents
[go: Go Back, main page]

NZ764889B2 - Composition for treating diabetes mellitus comprising insulin and a GLP-1/glucagon dual agonist - Google Patents

Composition for treating diabetes mellitus comprising insulin and a GLP-1/glucagon dual agonist Download PDF

Info

Publication number
NZ764889B2
NZ764889B2 NZ764889A NZ76488915A NZ764889B2 NZ 764889 B2 NZ764889 B2 NZ 764889B2 NZ 764889 A NZ764889 A NZ 764889A NZ 76488915 A NZ76488915 A NZ 76488915A NZ 764889 B2 NZ764889 B2 NZ 764889B2
Authority
NZ
New Zealand
Prior art keywords
glp
insulin
conjugate
region
composition according
Prior art date
Application number
NZ764889A
Other versions
NZ764889A (en
Inventor
In Young Choi
Sang Youn Hwang
Sung Youb Jung
Seung Su Kim
Se Chang Kwon
Original Assignee
Hanmi Pharm Co Ltd
Filing date
Publication date
Application filed by Hanmi Pharm Co Ltd filed Critical Hanmi Pharm Co Ltd
Publication of NZ764889A publication Critical patent/NZ764889A/en
Publication of NZ764889B2 publication Critical patent/NZ764889B2/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
    • A61K38/26—Glucagons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
    • A61K38/28—Insulins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/56—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
    • A61K47/59—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes
    • A61K47/60—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A61K47/6801—Drug-antibody or immunoglobulin conjugates defined by the pharmacologically or therapeutically active agent
    • A61K47/6803—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates
    • A61K47/6811—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates the drug being a protein or peptide, e.g. transferrin or bleomycin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A61K47/6889—Conjugates wherein the antibody being the modifying agent and wherein the linker, binder or spacer confers particular properties to the conjugates, e.g. peptidic enzyme-labile linkers or acid-labile linkers, providing for an acid-labile immuno conjugate wherein the drug may be released from its antibody conjugated part in an acidic, e.g. tumoural or environment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/46—Hybrid immunoglobulins
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K19/00—Hybrid peptides, i.e. peptides covalently bound to nucleic acids, or non-covalently bound protein-protein complexes
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52—Constant or Fc region; Isotype
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52—Constant or Fc region; Isotype
    • C07K2317/53—Hinge
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C07K2319/30—Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto

Abstract

The present invention relates to a pharmaceutical composition for treating diabetes mellitus comprising a long-acting insulin and a long-acting GLP-1/glucagon dual agonist conjugate. The long-acting insulin conjugate is a conjugate in which insulin is linked to an immunoglobulin Fc region via a non-peptidyl polymer, and the long-acting GLP-1/glucagon dual agonist conjugate is a conjugate in which GLP-1/glucagon dual agonist is linked to an immunoglobulin Fc region via a non-peptidyl polymer. Wherein, the insulin is an insulin analog in which A chain (SEQ ID NO 37) of the insulin is modified by substituting an amino acid at position 14 with glutamic acid of the chain A and the GLP-1/glucagon dual agonist comprises an amino acid sequence selected from the group consisting of amino acid sequences represented by SEQ ID NOs: 40, 62 to 66, and 70 to 72, and simultaneously activates GLP-1 receptor and glucagon receptors.

Claims (1)

1.Claims ?Claim 1? A pharmaceutical composition for treating diabetes mellitus comprising a long-acting insulin and a long-acting GLP-1/glucagon dual agonist conjugate; wherein the long-acting insulin conjugate is a conjugate in which insulin is linked to an immunoglobulin Fc region via a non-peptidyl polymer; wherein the long-acting GLP-1/glucagon dual agonist conjugate is a conjugate in which GLP-1/glucagon dual agonist is linked to an immunoglobulin Fc region via a nonpeptidyl polymer; wherein the insulin is an insulin analog in which A chain (SEQ ID NO 37) of the insulin is modified by substituting an amino acid at position 14 with glutamic acid of the chain A; and wherein the GLP-1/glucagon dual agonist comprises an amino acid sequence selected from the group consisting of amino acid sequences represented by SEQ ID NOs: 40, 62 to 66, and 70 to 72, and simultaneously activates GLP-1 receptor and glucagon receptors. ?Claim 2? The composition according to claim 1, wherein the long-acting glucagon-like peptide1 (GLP-1)/glucagon dual agonist has the amino acid sequence of SEQ ID NO.40 and the amino acid at position 16 and 20 form a ring. ?Claim 3? The composition according to claim 1 or claim 2, wherein the non-peptidyl polymer is selected from the group consisting of polyethylene glycol, polypropylene glycol, an ethylene glycol-propylene glycol copolymer, polyoxyethylated polyol, polyvinyl alcohol, a polysaccharide, dextran, polyvinyl ethyl ether, a biodegradable polymer, a lipid polymer, chitin, hyaluronic acid, and a combination thereof. ?Claim 4? The composition according to any one of claims 1 to 3, wherein the immunoglobulin Fc region is aglycosylated. ?Claim 5? The composition according to claim 4, wherein the immunoglobulin Fc region comprises one to four region(s) selected from the group consisting of CH1, CH2, CH3 and CH4 domains. ?Claim 6? The composition according to claim 5, wherein the immunoglobulin Fc region further comprises a hinge region. ?Claim 7? The composition according to claim 6, wherein the immunoglobulin Fc region is an 32 Fc region derived from IgG, IgA, IgD, IgE, or IgM. ?Claim 8? The composition according to claim 7, wherein each domain of the immunoglobulin Fc region is a hybrid of domains having a different origin selected from the group consisting of IgG, IgA, IgD, IgE, and IgM. ?Claim 9? The composition according to claim 8, wherein the immunoglobulin Fc region is a dimer or a multimer consisting of single-chain immunoglobulins consisting of domains having the same origin. ?Claim 10? The composition according to claim 1, wherein the composition further comprises a pharmaceutically acceptable carrier. ?Claim 11? The composition according to claim 1, wherein the long-acting insulin is a conjugate in which an insulin analog comprising substitution of the 14th amino acid in the insulin Achain with a glutamic acid and an immunoglobulin Fc region are linked by a non-peptidyl polymer linker, and the long-acting GLP-1/glucagon dual agonist is a conjugate in which a GLP-1/glucagon dual agonist represented by SEQ ID NO: 40 and an immunoglobulin Fc region are linked by a non-peptidyl polymer linker. ?Claim 12? The composition according to claim 11, wherein the 16th and 20th amino acid of the long-acting glucagon-like peptide-1 (GLP-1)/glucagon dual agonist represented by SEQ ID NO: 40 form a ring. ?Claim 13? The composition according to claim 11, wherein the non-peptidyl polymer linker is PEG. ?Claim 14? Use of a composition of any one of claims 1 to 13 in the manufacture of a medicament for preventing or treating diabetes mellitus. ?Claim 15? The use according to claim 14, wherein the long-acting insulin conjugate and the longacting GLP-1/glucagon dual agonist conjugate are for simultaneous, sequential, or reverse administration
NZ764889A 2015-06-01 Composition for treating diabetes mellitus comprising insulin and a GLP-1/glucagon dual agonist NZ764889B2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR20140066554 2014-05-30
NZ727871A NZ727871B2 (en) 2015-06-01 Composition for treating diabetes mellitus comprising insulin and a glp-1/glucagon dual agonist

Publications (2)

Publication Number Publication Date
NZ764889A NZ764889A (en) 2024-02-23
NZ764889B2 true NZ764889B2 (en) 2024-05-24

Family

ID=

Similar Documents

Publication Publication Date Title
RU2013152335A (en) COMPOSITION FOR TREATMENT OF DIABETES CONTAINING A LONG-TERM ANALYZING CONSULATE AND A LONG-TERM ANSULINOTROPIC PEPTIDE CONJUGATE
FI3322437T3 (en) Glucagon derivative and a composition comprising a long acting conjugate of the same
JP2017529354A5 (en)
AR100695A1 (en) COMPOSITION FOR THE TREATMENT OF MELLITUS DIABETES THAT INCLUDES INSULIN AND A DUAL AGONIST GLP-1 / GLUCAGÓN
AU2018203729B2 (en) Composition For Treating Hyperlipidemia Comprising Oxyntomodulin Derivative
JP2015510880A5 (en)
AR126851A2 (en) COMPOSITION TO PREVENT OR TREAT DIABETES, DIABESIS OR DIABETIC COMPLICATIONS
NZ585314A (en) A pharmaceutical composition for treating obesity-related disease comprising insulinotropic peptide conjugate
HRP20210739T1 (en) Antigen binding molecules comprising a tnf family ligand trimer
RU2016147505A (en) The conjugate containing oxyntomodulin and a fragment of immunoglobulin, and its use
RU2014108725A (en) PHARMACEUTICAL COMPOSITION FOR TREATMENT OF CANCER CONTAINING INTERFERON-ALPHA conjugate
JP2021035942A (en) Use of long-acting GLP-1 / glucagon receptor dual agonists to treat non-alcoholic fatty liver disease
RU2009129953A (en) INSULINOTROPIC COMPLEX IN WHICH THE IMMUNOGLOBULIN FRAGMENT IS USED
NZ628828A (en) Pharmaceutical composition for the prevention or treatment of non-alcoholic fatty liver disease
JP2016531915A5 (en)
RU2015138536A (en) A new insulin analogue and its use
JP2018502060A5 (en)
HRP20161050T1 (en) Her2/neu-specific antibodies and methods of using same
RU2016129894A (en) COVALENTLY RELATED HELICAR-ANTIBODY CONJUGATES AGAINST HELICAR AND THEIR APPLICATION
RU2012146663A (en) CONJUGATE OF INSULIN USING THE IMMUNOGLOBULIN FRAGMENT
JP2017527275A5 (en)
JP2020510671A5 (en)
JP2019524675A5 (en)
RU2014140744A (en) COMPOSITIONS CONTAINING SECRETORY-LIKE IMMUNOGLOBULINS
RU2016130108A (en) POLYPEPTIDE TOXIN AND ANTIBODIES CONNECTED WITH COVALENT COMMUNICATION