AU2021238951A1 - High concentration anti-Aß protofibril antibody formulations and methods of use thereof - Google Patents

High concentration anti-Aß protofibril antibody formulations and methods of use thereof Download PDF

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Publication number
AU2021238951A1
AU2021238951A1 AU2021238951A AU2021238951A AU2021238951A1 AU 2021238951 A1 AU2021238951 A1 AU 2021238951A1 AU 2021238951 A AU2021238951 A AU 2021238951A AU 2021238951 A AU2021238951 A AU 2021238951A AU 2021238951 A1 AU2021238951 A1 AU 2021238951A1
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AU
Australia
Prior art keywords
pharmaceutical formulation
arginine
concentration
fragment
seq
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
AU2021238951A
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English (en)
Inventor
Yung Yueh HSU
Anjali Joshi
Hirokazu Kito
Takahiro Ozawa
Takahisa Sakaguchi
Naomi SAKURAMOTO
Pierre SOUILLAC
Nobuo Yoshida
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 AU2021238951A1 publication Critical patent/AU2021238951A1/en
Pending legal-status Critical Current

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    • 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
    • A61K39/39591Stabilisation, fragmentation
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/13Amines
    • A61K31/133Amines having hydroxy groups, e.g. sphingosine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/28Drugs 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

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Dermatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Hospice & Palliative Care (AREA)
  • Psychiatry (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Cosmetics (AREA)
AU2021238951A 2020-03-20 2021-03-19 High concentration anti-Aß protofibril antibody formulations and methods of use thereof Pending AU2021238951A1 (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US202062992746P 2020-03-20 2020-03-20
US62/992,746 2020-03-20
US202063027263P 2020-05-19 2020-05-19
US63/027,263 2020-05-19
PCT/IB2021/000155 WO2021186245A1 (en) 2020-03-20 2021-03-19 HIGH CONCENTRATION ANTI-Aß PROTOFIBRIL ANTIBODY FORMULATIONS AND METHODS OF USE THEREOF

Publications (1)

Publication Number Publication Date
AU2021238951A1 true AU2021238951A1 (en) 2022-10-20

Family

ID=75746958

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2021238951A Pending AU2021238951A1 (en) 2020-03-20 2021-03-19 High concentration anti-Aß protofibril antibody formulations and methods of use thereof

Country Status (27)

Country Link
US (1) US20230183328A1 (https=)
EP (2) EP4121007B1 (https=)
JP (2) JP7689141B2 (https=)
KR (1) KR20220156534A (https=)
CN (1) CN115315251A (https=)
AU (1) AU2021238951A1 (https=)
BR (1) BR112022018766A2 (https=)
CA (1) CA3174778A1 (https=)
CL (2) CL2022002517A1 (https=)
CO (1) CO2022012916A2 (https=)
DK (1) DK4121007T3 (https=)
ES (1) ES3041762T3 (https=)
FI (1) FI4121007T3 (https=)
HR (1) HRP20251087T1 (https=)
HU (1) HUE072937T2 (https=)
IL (2) IL295383B1 (https=)
LT (1) LT4121007T (https=)
MA (1) MA59082B1 (https=)
MD (1) MD4121007T2 (https=)
MX (1) MX2022011101A (https=)
PH (1) PH12022552172A1 (https=)
PL (1) PL4121007T3 (https=)
PT (1) PT4121007T (https=)
RS (1) RS67249B1 (https=)
SI (1) SI4121007T1 (https=)
SM (1) SMT202500350T1 (https=)
WO (1) WO2021186245A1 (https=)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20230039734A (ko) 2020-07-23 2023-03-21 오타이르 프로테나 리미티드 항-Aβ 항체
AU2022307687A1 (en) 2021-07-09 2024-01-04 Eisai R&D Management Co., Ltd. Biomarkers for alzheimer's disease treatment
AU2022439338A1 (en) 2022-02-02 2024-08-15 Eisai R&D Management Co., Ltd. Methods of treatment using p-tau181 level
JP2025539394A (ja) 2022-11-28 2025-12-05 エーザイ・アール・アンド・ディー・マネジメント株式会社 タウpetレベルを使用する治療の方法
KR20260022396A (ko) 2023-06-09 2026-02-19 에자이 알앤드디 매니지먼트 가부시키가이샤 항-Aβ 프로토피브릴 항체를 사용한 치료 방법
WO2026015877A1 (en) 2024-07-12 2026-01-15 Eisai R&D Management Co., Ltd. Fluid biomarker

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PE20091174A1 (es) * 2007-12-27 2009-08-03 Chugai Pharmaceutical Co Ltd Formulacion liquida con contenido de alta concentracion de anticuerpo
CN118370815A (zh) 2017-08-22 2024-07-23 渤健马萨诸塞州股份有限公司 含有抗β淀粉样蛋白抗体的药物组合物
US20210324056A1 (en) 2018-07-24 2021-10-21 Eisai R&D Management Co., Ltd. Methods of treatment and prevention of alzheimer's disease

Also Published As

Publication number Publication date
PT4121007T (pt) 2025-09-25
LT4121007T (lt) 2025-09-25
BR112022018766A2 (pt) 2022-11-01
CA3174778A1 (en) 2021-09-23
EP4121007B1 (en) 2025-07-02
IL295383B1 (en) 2026-04-01
HUE072937T2 (hu) 2025-12-28
RS67249B1 (sr) 2025-10-31
TW202200201A (zh) 2022-01-01
KR20220156534A (ko) 2022-11-25
JP2023518066A (ja) 2023-04-27
PH12022552172A1 (en) 2023-12-11
FI4121007T3 (fi) 2025-09-11
CN115315251A (zh) 2022-11-08
EP4121007A1 (en) 2023-01-25
EP4252777A9 (en) 2024-03-06
MX2022011101A (es) 2022-10-03
PL4121007T3 (pl) 2025-11-03
JP2025111516A (ja) 2025-07-30
WO2021186245A1 (en) 2021-09-23
MA59082B1 (fr) 2025-09-30
CL2022002517A1 (es) 2023-03-24
ES3041762T3 (en) 2025-11-14
SMT202500350T1 (it) 2025-11-10
CL2024003428A1 (es) 2025-04-11
JP7689141B2 (ja) 2025-06-05
HRP20251087T1 (hr) 2025-11-07
SI4121007T1 (sl) 2025-10-30
CO2022012916A2 (es) 2022-09-20
IL295383A (en) 2022-10-01
IL326613A (en) 2026-04-01
EP4252777A3 (en) 2024-01-24
DK4121007T3 (da) 2025-09-22
US20230183328A1 (en) 2023-06-15
MD4121007T2 (ro) 2025-11-30
EP4252777A2 (en) 2023-10-04

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