DE112019003835T5 - Arzneimittel zur verwendung bei der behandlung oder vorbeugung einer mit c5 in zusammenhang stehenden erkrankung sowie verfahren zur behandlung oder vorbeugung einer mit c5 in zusammenhang stehenden erkrankung - Google Patents

Arzneimittel zur verwendung bei der behandlung oder vorbeugung einer mit c5 in zusammenhang stehenden erkrankung sowie verfahren zur behandlung oder vorbeugung einer mit c5 in zusammenhang stehenden erkrankung Download PDF

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Publication number
DE112019003835T5
DE112019003835T5 DE112019003835.4T DE112019003835T DE112019003835T5 DE 112019003835 T5 DE112019003835 T5 DE 112019003835T5 DE 112019003835 T DE112019003835 T DE 112019003835T DE 112019003835 T5 DE112019003835 T5 DE 112019003835T5
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DE
Germany
Prior art keywords
days
antibody
phase
dose
period
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
DE112019003835.4T
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German (de)
English (en)
Inventor
Kenji SHINOMIYA
Keisuke Gotanda
Jun-ichi Nishimura
Erica Winter
Joy C. Hsu
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
F Hoffmann La Roche AG
Chugai Pharmaceutical Co Ltd
University of Osaka NUC
Original Assignee
F Hoffmann La Roche AG
Chugai Pharmaceutical Co Ltd
Osaka University NUC
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Filing date
Publication date
Application filed by F Hoffmann La Roche AG, Chugai Pharmaceutical Co Ltd, Osaka University NUC filed Critical F Hoffmann La Roche AG
Publication of DE112019003835T5 publication Critical patent/DE112019003835T5/de
Pending legal-status Critical Current

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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A61K9/0021—Intradermal administration, e.g. through microneedle arrays or needleless injectors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/06—Antianaemics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/54—Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/73—Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/92—Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Epidemiology (AREA)
  • Dermatology (AREA)
  • Genetics & Genomics (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Transplantation (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Biophysics (AREA)
  • Rheumatology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Pain & Pain Management (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
DE112019003835.4T 2018-08-01 2019-08-01 Arzneimittel zur verwendung bei der behandlung oder vorbeugung einer mit c5 in zusammenhang stehenden erkrankung sowie verfahren zur behandlung oder vorbeugung einer mit c5 in zusammenhang stehenden erkrankung Pending DE112019003835T5 (de)

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
US201862713211P 2018-08-01 2018-08-01
US62/713,211 2018-08-01
US201862764952P 2018-08-17 2018-08-17
US62/764,952 2018-08-17
US201862760204P 2018-11-13 2018-11-13
US62/760,204 2018-11-13
PCT/JP2019/030283 WO2020027279A1 (en) 2018-08-01 2019-08-01 A pharmaceutical composition for use in the treatment or prevention of a c5-related disease and a method for treating or preventing a c5-related disease

Publications (1)

Publication Number Publication Date
DE112019003835T5 true DE112019003835T5 (de) 2021-05-27

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
DE112019003835.4T Pending DE112019003835T5 (de) 2018-08-01 2019-08-01 Arzneimittel zur verwendung bei der behandlung oder vorbeugung einer mit c5 in zusammenhang stehenden erkrankung sowie verfahren zur behandlung oder vorbeugung einer mit c5 in zusammenhang stehenden erkrankung

Country Status (23)

Country Link
US (1) US20210301004A1 (https=)
EP (2) EP3829628B1 (https=)
JP (4) JP6672516B2 (https=)
KR (5) KR20200033348A (https=)
CN (1) CN112512563A (https=)
AU (2) AU2019315213B2 (https=)
BR (1) BR112021001655A2 (https=)
CA (1) CA3107618A1 (https=)
CR (1) CR20210103A (https=)
DE (1) DE112019003835T5 (https=)
ES (1) ES2980137T3 (https=)
HR (1) HRP20240823T1 (https=)
HU (1) HUE067057T2 (https=)
IL (2) IL324626A (https=)
MX (2) MX2021000516A (https=)
MY (1) MY210523A (https=)
PH (1) PH12021550226A1 (https=)
PL (1) PL3829628T3 (https=)
RS (1) RS65630B1 (https=)
SG (1) SG10202002898RA (https=)
SM (1) SMT202400271T1 (https=)
TW (2) TWI704157B (https=)
WO (1) WO2020027279A1 (https=)

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ES2892925T3 (es) 2006-03-31 2022-02-07 Chugai Pharmaceutical Co Ltd Métodos para controlar la farmacocinética en sangre de anticuerpos
CN101874042B9 (zh) 2007-09-26 2019-01-01 中外制药株式会社 利用cdr的氨基酸取代来改变抗体等电点的方法
KR102057826B1 (ko) 2008-04-11 2019-12-20 추가이 세이야쿠 가부시키가이샤 복수 분자의 항원에 반복 결합하는 항원 결합 분자
TWI812066B (zh) 2010-11-30 2023-08-11 日商中外製藥股份有限公司 具有鈣依存性的抗原結合能力之抗體
CN107207607B (zh) 2014-12-19 2021-05-04 中外制药株式会社 抗-c5抗体及使用方法
KR101860280B1 (ko) 2014-12-19 2018-05-21 추가이 세이야쿠 가부시키가이샤 항-마이오스타틴 항체, 변이체 Fc 영역을 함유하는 폴리펩타이드, 및 사용 방법
CN114773470A (zh) 2015-02-05 2022-07-22 中外制药株式会社 包含离子浓度依赖性的抗原结合结构域的抗体，fc区变体，il-8-结合抗体及其应用
US11359009B2 (en) 2015-12-25 2022-06-14 Chugai Seiyaku Kabushiki Kaisha Anti-myostatin antibodies and methods of use
TWI693940B (zh) 2016-08-05 2020-05-21 日商中外製藥股份有限公司 Ｉｌ-８相關疾病之治療用或預防用組成物

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Also Published As

Publication number Publication date
WO2020027279A1 (en) 2020-02-06
JP2025065367A (ja) 2025-04-17
JP6672533B1 (ja) 2020-03-25
EP4445913A2 (en) 2024-10-16
RS65630B1 (sr) 2024-07-31
JP6672516B2 (ja) 2020-03-25
JP2020019769A (ja) 2020-02-06
EP3829628B1 (en) 2024-05-15
EP3829628A1 (en) 2021-06-09
MX2025010400A (es) 2025-10-01
KR20210038697A (ko) 2021-04-07
PL3829628T3 (pl) 2024-08-19
MX2021000516A (es) 2021-04-12
EP4445913A3 (en) 2025-01-01
AU2024205486A1 (en) 2024-08-22
KR20200033348A (ko) 2020-03-27
US20210301004A1 (en) 2021-09-30
JP2020073608A (ja) 2020-05-14
IL280475B1 (en) 2025-12-01
CA3107618A1 (en) 2020-02-06
MY210523A (en) 2025-09-29
AU2019315213A1 (en) 2021-03-25
IL280475B2 (en) 2026-04-01
EP3829628C0 (en) 2024-05-15
TWI704157B (zh) 2020-09-11
HUE067057T2 (hu) 2024-09-28
HRP20240823T1 (hr) 2024-09-27
CR20210103A (es) 2021-03-22
PH12021550226A1 (en) 2021-10-11
IL324626A (en) 2026-01-01
AU2019315213B2 (en) 2024-05-02
TWI701041B (zh) 2020-08-11
JP2020079331A (ja) 2020-05-28
TW202019467A (zh) 2020-06-01
KR20200033225A (ko) 2020-03-27
BR112021001655A2 (pt) 2021-05-04
IL280475A (en) 2021-03-01
CN112512563A (zh) 2021-03-16
TW202024128A (zh) 2020-07-01
ES2980137T3 (es) 2024-09-30
KR20240115904A (ko) 2024-07-26
SG10202002898RA (en) 2020-05-28
KR20210037743A (ko) 2021-04-06
SMT202400271T1 (it) 2024-07-09

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