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AR100695A1 - Composición para el tratamiento de diabetes mellitus que comprende insulina y un agonista dual glp-1 / glucagón - Google Patents

Composición para el tratamiento de diabetes mellitus que comprende insulina y un agonista dual glp-1 / glucagón

Info

Publication number
AR100695A1
AR100695A1 ARP150101721A ARP150101721A AR100695A1 AR 100695 A1 AR100695 A1 AR 100695A1 AR P150101721 A ARP150101721 A AR P150101721A AR P150101721 A ARP150101721 A AR P150101721A AR 100695 A1 AR100695 A1 AR 100695A1
Authority
AR
Argentina
Prior art keywords
insulin
glp
glucagon
composition according
acting
Prior art date
Application number
ARP150101721A
Other languages
English (en)
Original Assignee
Hanmi Pharm Ind Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=54699312&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=AR100695(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Hanmi Pharm Ind Co Ltd filed Critical Hanmi Pharm Ind Co Ltd
Publication of AR100695A1 publication Critical patent/AR100695A1/es

Links

Classifications

    • 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
    • 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
    • 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 [IGs], 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

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Organic Chemistry (AREA)
  • Diabetes (AREA)
  • Endocrinology (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Obesity (AREA)
  • Hematology (AREA)
  • Emergency Medicine (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)
  • Inorganic Chemistry (AREA)

Abstract

Composición para prevenir o tratar diabetes mellitus que comprende insulina y un agonista dual de GLP-1 / glucagón, y un método para prevenir o tratar diabetes mellitus. Más específicamente, la presente composición puede inhibir el aumento de peso y reducir el peligro de hipoglucemia debido a la administración de insulina, reducir la dosis de administración y aumentar notablemente el cumplimiento con los fármacos a través de una administración combinada de un conjugado de insulina de acción prolongada y un conjugado del agonista dual de GLP-1 / glucagón de acción prolongada. Además, el conjugado de insulina de acción prolongada y el conjugado del agonista dual de GLP-1 / glucagón de acción prolongada de acuerdo con la presente puede mejorar la sostenibilidad y estabilidad in vivo debido a que una insulina y un agonista dual de GLP-1 / glucagón se ligan a la región Fc de la inmunoglobulina por medio de un ligador no peptidilo. Reivindicación 1: Una composición farmacéutica para tratar diabetes mellitus que comprende insulina y un agonista dual de GLP-1 / glucagón. Reivindicación 2: La composición de acuerdo con la reivindicación 1, en donde la insulina es insulina nativa, insulina de acción rápida, insulina basal, un análogo de insulina que es una variante de insulina preparada por cualquier método de sustitución, adición, supresión, modificación, o una de sus combinaciones de la secuencia de aminoácidos de la insulina nativa, o un fragmento de esta, y el agonista dual de GLP-1 / glucagón activa simultáneamente el receptor de GLP-1 y los receptores de glucagón. Reivindicación 3: La composición de acuerdo con la reivindicación 1, en donde la insulina y el agonista dual de GLP-1 / glucagón son acción prolongada. Reivindicación 5: La composición de acuerdo con la reivindicación 3, en donde cada una de la insulina y el agonista dual de GLP-1 / glucagón es un conjugado de acción prolongada en donde un material biocompatible es capaz de extender la duración de la activación se liga a la insulina o agonista dual de GLP-1 / glucagón mediante un ligador o un enlace covalente. Reivindicación 6: La composición de acuerdo con la reivindicación 5, en donde el material biocompatible se selecciona del grupo que consiste en polietilenglicol, acido graso, colesterol, albúmina y un fragmento de estos, un material de unión a albúmina, un polímero que tiene una secuencia de aminoácidos particular como unidad repetida, un anticuerpo, un fragmento del anticuerpo, un material de unión a FcRn, un tejidos conectivo o un derivado de este, nucleótidos, fibronectina, transfenina, un sacárido, y un polímero macromolecular. Reivindicación 7: La composición de acuerdo con la reivindicación 6, en donde cada una de la insulina y el agonista dual de GLP-1 / glucagón se liga a una región Fc de la inmunoglobulina, perteneciente al material de unión a FcRn, mediante un ligador polimérico no peptidilo seleccionado del grupo que consiste en polietilenglicol, polipropilenglicol, un copolímero de etilenglicol-propilenglicol, poliol polioxietilado, alcohol polivinílico, polisacárido, dextrano, polivinil etil éter, un polímero biodegradable, un polímero lipídico, quitina, ácido hialurónico, y una de sus combinaciones. Reivindicación 8: La composición de acuerdo con la reivindicación 7, en donde el polímero no peptidilo se selecciona del grupo que consiste en polietilenglicol, polipropilenglicol, un copolímero de etilenglicol-propilenglicol, poliol polioxietilado, alcohol polivinílico, un polisacárido, dextrano, polivinil etil éter, un polímero biodegradable, un polímero lipídico, quitina, acido hialurónico, y una de sus combinaciones. Reivindicación 9: La composición de acuerdo con la reivindicación 7, en donde la región Fc de la inmunoglobulina está aglicosilada.
ARP150101721A 2014-05-30 2015-05-29 Composición para el tratamiento de diabetes mellitus que comprende insulina y un agonista dual glp-1 / glucagón AR100695A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
KR20140066554 2014-05-30

Publications (1)

Publication Number Publication Date
AR100695A1 true AR100695A1 (es) 2016-10-26

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ARP150101721A AR100695A1 (es) 2014-05-30 2015-05-29 Composición para el tratamiento de diabetes mellitus que comprende insulina y un agonista dual glp-1 / glucagón

Country Status (21)

Country Link
US (1) US10188703B2 (es)
EP (1) EP3148571B1 (es)
JP (2) JP6749845B2 (es)
KR (1) KR102429920B1 (es)
CN (2) CN119303105A (es)
AR (1) AR100695A1 (es)
AU (2) AU2015268199B2 (es)
CA (1) CA2950718C (es)
CL (1) CL2016003069A1 (es)
EA (1) EA201692282A1 (es)
ES (1) ES2897732T3 (es)
IL (1) IL249264B (es)
MX (1) MX383413B (es)
MY (1) MY175421A (es)
PE (2) PE20231199A1 (es)
PH (1) PH12016502390A1 (es)
SG (2) SG11201609872YA (es)
TW (1) TWI684458B (es)
UA (1) UA125166C2 (es)
WO (1) WO2015183054A1 (es)
ZA (1) ZA201608764B (es)

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KR20200078414A (ko) * 2018-12-21 2020-07-01 한미약품 주식회사 인슐린 및 글루카곤을 포함하는 약학 조성물
WO2021142733A1 (en) * 2020-01-16 2021-07-22 Shanghai Benemae Pharmaceutical Corporation Combinational therapy comprising glp-1 and/or glp-1 analogs, and insulin and/or insulin analogs
CN113292646B (zh) * 2020-05-29 2022-05-13 东莞云璟生物技术有限公司 Glp-1/胰高血糖素双重激动剂融合蛋白
CN114788876B (zh) * 2022-02-24 2024-07-05 北京医院 治疗糖尿病的mRNA药物制剂及其制备方法与应用
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