JP2024532438A - 抗Ａβプロトフィブリル抗体の皮下製剤及びその使用方法 - Google Patents

抗Ａβプロトフィブリル抗体の皮下製剤及びその使用方法 Download PDF

Info

Publication number
JP2024532438A
JP2024532438A JP2024513446A JP2024513446A JP2024532438A JP 2024532438 A JP2024532438 A JP 2024532438A JP 2024513446 A JP2024513446 A JP 2024513446A JP 2024513446 A JP2024513446 A JP 2024513446A JP 2024532438 A JP2024532438 A JP 2024532438A
Authority
JP
Japan
Prior art keywords
subject
week
dose
seq
administered
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
JP2024513446A
Other languages
English (en)
Japanese (ja)
Other versions
JP2024532438A5 (https=
Inventor
ロバート ゴードン，
イシャニ ランドリー，
パラヴィ サチデブ，
デイビッド バーベル，
リン クレイマー，
道雄 兼清
彰比古 小山
チャド スワンソン，
マイケル イリザリー，
ジューン カプロウ，
ショバ ダッダ，
ラリサ レイダーマン，
誠一 早戸
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.)
Eisai R&D Management Co Ltd
Original Assignee
Eisai R&D Management 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
Application filed by Eisai R&D Management Co Ltd filed Critical Eisai R&D Management Co Ltd
Publication of JP2024532438A publication Critical patent/JP2024532438A/ja
Publication of JP2024532438A5 publication Critical patent/JP2024532438A5/ja
Pending legal-status Critical Current

Links

Images

Classifications

    • 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
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • 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
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • 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
    • 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
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • 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
    • A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Immunology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dermatology (AREA)
  • Psychiatry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Hospice & Palliative Care (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Endocrinology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)
JP2024513446A 2021-08-30 2022-08-29 抗Ａβプロトフィブリル抗体の皮下製剤及びその使用方法 Pending JP2024532438A (ja)

Applications Claiming Priority (11)

Application Number Priority Date Filing Date Title
US202163260730P 2021-08-30 2021-08-30
US63/260,730 2021-08-30
US202263306050P 2022-02-02 2022-02-02
US63/306,050 2022-02-02
US202263269389P 2022-03-15 2022-03-15
US63/269,389 2022-03-15
US202263269463P 2022-03-16 2022-03-16
US63/269,463 2022-03-16
US202263364619P 2022-05-12 2022-05-12
US63/364,619 2022-05-12
PCT/US2022/041926 WO2023034230A1 (en) 2021-08-30 2022-08-29 Subcutaneous formulations of anti-abeta protofibril antibody and methods of use thereof

Publications (2)

Publication Number Publication Date
JP2024532438A true JP2024532438A (ja) 2024-09-05
JP2024532438A5 JP2024532438A5 (https=) 2025-09-05

Family

ID=83438517

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2024513446A Pending JP2024532438A (ja) 2021-08-30 2022-08-29 抗Ａβプロトフィブリル抗体の皮下製剤及びその使用方法

Country Status (9)

Country Link
US (1) US20240352109A1 (https=)
EP (1) EP4395821A1 (https=)
JP (1) JP2024532438A (https=)
KR (1) KR20240053620A (https=)
AU (1) AU2022338055A1 (https=)
CA (1) CA3230148A1 (https=)
MX (1) MX2024002567A (https=)
TW (1) TW202328178A (https=)
WO (1) WO2023034230A1 (https=)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20260022396A (ko) * 2023-06-09 2026-02-19 에자이 알앤드디 매니지먼트 가부시키가이샤 항-Aβ 프로토피브릴 항체를 사용한 치료 방법
CN116953261B (zh) * 2023-08-10 2024-09-17 浙江格物致知生物科技有限公司 一种检测脓毒症的联检试剂盒及其应用

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2414772C (en) 2000-07-07 2011-06-28 Jan Naslund Prevention and treatment of alzheimer's disease
SE0401601D0 (sv) 2004-06-21 2004-06-21 Bioarctic Neuroscience Ab Protofibril specific antibodies and uses thereof
RU2429244C2 (ru) 2006-03-23 2011-09-20 Байоарктик Ньюросайенс Аб Улучшенные селективные в отношении протофибрилл антитела и их применение
LT2448968T (lt) 2009-06-29 2021-05-10 Bioarctic Ab Antikūnai, atpažįstantys n gale sutrumpintas amiloido protofibriles/oligomerus
JP5894939B2 (ja) 2010-02-26 2016-03-30 バイオアークティック ニューロサイエンス アーベー プロトフィブリル結合抗体ならびにパーキンソン病、レビー小体型認知症および他のα−シヌクレイノパチーの治療および診断方法におけるこれらの使用
WO2016005466A2 (en) 2014-07-10 2016-01-14 Bioarctic Neuroscience Ab IMPROVED Aß PROTOFIBRIL BINDING ANTIBODIES
BR112019008359A2 (pt) * 2016-10-27 2019-10-01 Eisai R&D Man Co Ltd método para tratamento da doença de alzheimer, e, composição farmacêutica.

Also Published As

Publication number Publication date
TW202328178A (zh) 2023-07-16
US20240352109A1 (en) 2024-10-24
AU2022338055A1 (en) 2024-02-29
EP4395821A1 (en) 2024-07-10
MX2024002567A (es) 2024-03-20
WO2023034230A1 (en) 2023-03-09
KR20240053620A (ko) 2024-04-24
CA3230148A1 (en) 2023-03-09

Similar Documents

Publication Publication Date Title
JP2026012271A (ja) アルツハイマー病を治療するための抗ベータ－アミロイド抗体
JP2025160337A (ja) アルツハイマー病を治療する方法
US20250163135A1 (en) Biomarkers for alzheimer's disease treatment
JP2025506389A (ja) ｐ－タウ１８１レベルを使用した治療方法
JP2024532438A (ja) 抗Ａβプロトフィブリル抗体の皮下製剤及びその使用方法
TWI894689B (zh) 抗N3pGlu類澱粉蛋白β抗體、其劑量及其用途
JP2025539394A (ja) タウｐｅｔレベルを使用する治療の方法
US20250051427A1 (en) Methods of using an anti-amyloid beta protofibril antibody and anti-tau antibody
CN117999094A (zh) 抗Aβ初原纤维抗体的皮下配制品及其使用方法
TW202313111A (zh) 治療阿茲海默症之方法
CN121335711A (zh) 使用抗Aβ初原纤维抗体的治疗方法
EA052963B1 (ru) Способы применения антитела к протофибриллам бета-амилоида и антитела к тау-белку
CN118786141A (zh) 使用p-tau181水平的治疗方法

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20250828

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20250828