DK2739311T3 - Fremgangsmåde til behandling af knoglespaltedefekter - Google Patents

Fremgangsmåde til behandling af knoglespaltedefekter Download PDF

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DK2739311T3
DK2739311T3 DK12746235.6T DK12746235T DK2739311T3 DK 2739311 T3 DK2739311 T3 DK 2739311T3 DK 12746235 T DK12746235 T DK 12746235T DK 2739311 T3 DK2739311 T3 DK 2739311T3
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seq
bone
antibody
sclerostin
sclerostin antibody
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DK12746235.6T
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Xiaodong Li
Hua Zhu Ke
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Amgen Inc
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    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/22Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against growth factors ; against growth regulators
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/08Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/545Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/70Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76Antagonist effect on antigen, e.g. neutralization or inhibition of binding

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Microbiology (AREA)
  • Endocrinology (AREA)
  • Mycology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Rheumatology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Claims (15)

1. Effektiv mængde af et anti-sclerostin antistof til anvendelse i en fremgangsmåde til behandling af en knoglespaltedefekt hos et pattedyrsindivid, hvor antistoffet er en sclerostin-hæmmer, hvilken fremgangsmåde omfatter administration af antistoffet til individet, hvor anti-sclerostin-antistoffet administreres over en behandlingsperiode, der mindst varer 20 uger, og hvor knoglespaltedefekten omfatter en spalte mellem to knoglesegmenter på mindst 5 mm.
2. Anti-sclerostin-antistof til anvendelse i fremgangsmåden ifølge krav 1, hvor anti-sclerostin-antistoffet administreres i en ugentlig dosis fra 1 mg/kg til 50 mg/kg pr. uge.
3. Anti-sclerostin-antistof til anvendelse i fremgangsmåden ifølge krav 1, hvor behandlingsperioden varer 28 uger.
4. Anti-sclerostin-antistof til anvendelse i fremgangsmåden ifølge krav 1, hvor knoglespaltedefekten er udvalgt fra gruppen bestående af en komminut fraktur, en ikke-sammenvokset fraktur, en segmentarisk skeletdefekt, kirurgisk frembragte knogledefekter, kirurgisk behandlede knogledefekter og knogledefekter fremkommet ved traumatisk læsion af knoglen eller sygdom (herunder arthritis, udviklingsdeformitet, tumorfjernelse (resektion) eller fjernelse af infektion).
5. Anti-sclerostin-antistof til anvendelse i fremgangsmåden ifølge krav 4, hvor knoglespaltedefekten er frembragt ved fjernelse af inficerede knoglesektioner eller fjernelse af cancer fra knoglen.
6. Anti-sclerostin-antistof til anvendelse i fremgangsmåden ifølge krav 1, hvor fremgangsmåden endvidere omfatter administration af et andet knoglestyrkende terapeutisk middel udvalgt fra gruppen bestående af parathyroideahormon, et bisphosphonat, et RANKL-antistof og et DKK-1-antistof.
7. Anti-sclerostin-antistof til anvendelse i fremgangsmåden ifølge et hvilket som helst af kravene 1-6, hvor anti-sclerostin-antistoffet administreres: (a) i en mængde af 30 mg/kg pr. uge; og/eller (b) én gang ugentligt i behandlingsperiodens varighed.
8. Anti-sclerostin-antistof til anvendelse i fremgangsmåden ifølge et hvilket som helst af kravene 1-7, hvor behandling med anti-sclerostin-antistoffet ikke resulterer i en væsentlig stigning i kortikal porøsitet i individets knogle.
9. Anti-sclerostin-antistof til anvendelse i fremgangsmåden ifølge et hvilket som helst af kravene 1-8, hvor anti-sclerostin-antistoffet administreres subkutant.
10. Anti-sclerostin-antistof til anvendelse i fremgangsmåden ifølge et hvilket som helst af kravene 1-9, hvor anti-sclerostin-antistoffet er et immunoglobulin, der omfatter en tungkæde og en ledkæde.
11. Anti-sclerostin-antistof til anvendelse i fremgangsmåden ifølge et hvilket som helst af kravene 1-9, hvor anti-sclerostin-antistoffet er et antistof eller fragment deraf, der udviser en bindingsaffinitet for sclerostin ifølge SEQ ID NO: 1 på mindre end eller lig med 1 x 10'7 M.
12. Anti-sclerostin-antistof til anvendelse i fremgangsmåden ifølge et hvilket som helst af kravene 1-11, hvor anti-sclerostin-antistoffet binder til et sclerostin-polypeptid, der omfatter aminosyresekvensen ifølge SEQ ID NO: 1, hvor: (a) anti-sclerostin-antistoffet binder til sekvensen af SEQ ID NO: 6; (b) anti-sclerostin-antistoffet binder til sekvensen af mindst én af SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 4 eller SEQ ID NO: 5; eller (c) anti-sclerostin-antistoffet binder til sekvensen af mindst én af SEQ ID NO: 70, SEQ ID NO: 71, SEQ ID NO: 72 eller SEQ ID NO: 73.
13. Anti-sclerostin-antistof til anvendelse i fremgangsmåden ifølge et hvilket som helst af kravene 1-11, hvor anti-sclerostin-antistoffet tværblokerer bindingen af mindst ét af antistofferne Ab-A, Ab-B, Ab-C, Ab-D, Ab-1, Ab-2, Ab-3, Ab-4, Ab-5, Ab-6, Ab-7, Ab-8, Ab-9, Ab-10, Ab-11, Ab-12, Ab-13, Ab-14, Ab-15, Ab-16, Ab-17, Ab-18, Ab-19, Ab-20, Ab-21, Ab-22, Ab-23 og Ab-24 til sclerostin og/eller er tværblokeret mod binding til sclerostin af mindst ét af antistofferne Ab-A, Ab-B, Ab-C, Ab-D, Ab-1, Ab-2, Ab-3, Ab-4, Ab-5, Ab-6, Ab-7, Ab-8, Ab-9, Ab-10, Ab-11, Ab-12, Ab- 13, Ab-14, Ab-15, Ab-16, Ab-17, Ab-18, Ab-19, Ab-20, Ab-21, Ab-22, Ab-23 og Ab-24, hvor antistofferne Ab-A til Ab-D og Ab-1 til Ab-24 har de tung- og letkædesekvenser, der er identificeret i figur 1.
14. Anti-sclerostin-antistof til anvendelse i fremgangsmåden ifølge et hvilket som helst af kravene 1-11, hvor anti-sclerostin-antistoffet omfatter en CDR-H1 ifølge SEQ ID NO: 245, en CDR-H2 ifølge SEQ ID NO: 246, en CDR-H3 ifølge SEQ ID NO: 247, en CDR-L1 ifølge SEQ ID NO: 78, en CDR-L2 ifølge SEQ ID NO: 79 og en CDR-L3 ifølge SEQ ID NO: 80.
15. Anti-sclerostin-antistof til anvendelse i fremgangsmåden ifølge krav 14, hvor anti-sclerostin-antistof: (a) omfatter tungkæder, der omfatter SEQ ID NO: 378 og letkæder, der omfatter SEQ ID NO 376; eller (b) har tungkæder ifølge SEQ ID NO: 145 eller SEQ ID NO: 392 og letkæder ifølge SEQ ID NO: 141.
DK12746235.6T 2011-08-04 2012-08-02 Fremgangsmåde til behandling af knoglespaltedefekter DK2739311T3 (da)

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US201161515191P 2011-08-04 2011-08-04
PCT/US2012/049331 WO2013019954A1 (en) 2011-08-04 2012-08-02 Method for treating bone gap defects

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US (2) US10538584B2 (da)
EP (1) EP2739311B9 (da)
JP (4) JP6301832B2 (da)
AU (1) AU2012290083B2 (da)
CA (1) CA2842432C (da)
CY (1) CY1120666T1 (da)
DK (1) DK2739311T3 (da)
ES (1) ES2667554T3 (da)
HR (1) HRP20180736T1 (da)
HU (1) HUE039786T2 (da)
LT (1) LT2739311T (da)
MX (1) MX355816B (da)
NO (1) NO2739311T3 (da)
PL (1) PL2739311T3 (da)
PT (1) PT2739311T (da)
SI (1) SI2739311T1 (da)
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UY35148A (es) * 2012-11-21 2014-05-30 Amgen Inc Immunoglobulinas heterodiméricas
WO2015087187A1 (en) * 2013-12-10 2015-06-18 Rinat Neuroscience Corp. Anti-sclerostin antibodies
US10961305B2 (en) 2016-12-21 2021-03-30 Mereo Biopharma 3 Limited Use of anti-sclerostin antibodies in the treatment of osteogenesis imperfecta
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US20200115444A1 (en) 2020-04-16
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