AU2022348798A1 - Compositions and methods for treating synucleinopathies - Google Patents

Compositions and methods for treating synucleinopathies Download PDF

Info

Publication number
AU2022348798A1
AU2022348798A1 AU2022348798A AU2022348798A AU2022348798A1 AU 2022348798 A1 AU2022348798 A1 AU 2022348798A1 AU 2022348798 A AU2022348798 A AU 2022348798A AU 2022348798 A AU2022348798 A AU 2022348798A AU 2022348798 A1 AU2022348798 A1 AU 2022348798A1
Authority
AU
Australia
Prior art keywords
antibody
alpha synuclein
pharmaceutical composition
liquid pharmaceutical
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
AU2022348798A
Other languages
English (en)
Inventor
Louise BUUR
Magdalena GAUDEN
Pekka Kallunki
Derrick Spencer KATAYAMA
Frank Larsen
Mark Cornell Manning
Anne Sofie Markussen
Josefine NIELSEN SØDERBERG
Henrik Rajesh Kumar Parshad
John Smith
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.)
H Lundbeck AS
Original Assignee
H Lundbeck AS
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 H Lundbeck AS filed Critical H Lundbeck AS
Publication of AU2022348798A1 publication Critical patent/AU2022348798A1/en
Pending legal-status Critical Current

Links

Classifications

    • 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
    • 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
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591Stabilisation, fragmentation
    • 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
    • A61K47/22Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/02Drugs for disorders of the nervous system for peripheral neuropathies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/14Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • A61P25/16Anti-Parkinson drugs
    • 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
    • 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
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/30Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/33Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/30Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/34Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565Complementarity determining region [CDR]
    • 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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/92Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94Stability, e.g. half-life, pH, temperature or enzyme-resistance

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)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Psychology (AREA)
  • Psychiatry (AREA)
  • Dermatology (AREA)
  • Hospice & Palliative Care (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)
AU2022348798A 2021-09-16 2022-09-13 Compositions and methods for treating synucleinopathies Pending AU2022348798A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EPEP21197120 2021-09-16
EP21197120 2021-09-16
PCT/EP2022/075402 WO2023041524A2 (en) 2021-09-16 2022-09-13 Compositions and methods for treating synucleinopathies

Publications (1)

Publication Number Publication Date
AU2022348798A1 true AU2022348798A1 (en) 2024-03-14

Family

ID=78049153

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2022348798A Pending AU2022348798A1 (en) 2021-09-16 2022-09-13 Compositions and methods for treating synucleinopathies

Country Status (12)

Country Link
US (5) US12077578B2 (https=)
EP (1) EP4401770A2 (https=)
JP (1) JP2024534947A (https=)
KR (1) KR20240055758A (https=)
CN (1) CN117915952A (https=)
AR (1) AR127054A1 (https=)
AU (1) AU2022348798A1 (https=)
CA (1) CA3230055A1 (https=)
CL (2) CL2024000753A1 (https=)
IL (1) IL311344A (https=)
MX (1) MX2024002970A (https=)
WO (1) WO2023041524A2 (https=)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
BR112018014281A2 (pt) * 2016-11-15 2018-12-18 H Lundbeck As agentes, usos e métodos para o tratamento da sinucleinopatia
EP4401770A2 (en) * 2021-09-16 2024-07-24 H. Lundbeck A/S Compositions and methods for treating synucleinopathies
CN121794293A (zh) * 2023-09-14 2026-04-03 豪夫迈·罗氏有限公司 抗体制剂
WO2025186235A1 (en) 2024-03-05 2025-09-12 H. Lundbeck A/S Compositions and methods for treating multiple system atrophy (msa)

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PL2361928T3 (pl) * 2003-05-19 2017-09-29 Prothena Biosciences Limited Skrócone fragmenty alfa-synukleiny w chorobie z ciałami Lewy'ego
US10513555B2 (en) * 2013-07-04 2019-12-24 Prothena Biosciences Limited Antibody formulations and methods
WO2016077687A1 (en) 2014-11-14 2016-05-19 Voyager Therapeutics, Inc. Compositions and methods of treating amyotrophic lateral sclerosis (als)
GB201512203D0 (en) 2015-07-13 2015-08-19 Lundbeck & Co As H Agents,uses and methods
WO2017176835A2 (en) * 2016-04-06 2017-10-12 Imago Pharmaceuticals, Inc. Therapeutic antibodies for treatment of neurodegeneration
BR112018014281A2 (pt) * 2016-11-15 2018-12-18 H Lundbeck As agentes, usos e métodos para o tratamento da sinucleinopatia
JOP20190227A1 (ar) * 2017-03-31 2019-09-30 Biogen Int Neuroscience Gmbh تركيبات وطرق لعلاج اعتلالات السينوكلين
EP4401770A2 (en) 2021-09-16 2024-07-24 H. Lundbeck A/S Compositions and methods for treating synucleinopathies

Also Published As

Publication number Publication date
US20240025979A1 (en) 2024-01-25
WO2023041524A3 (en) 2023-05-11
WO2023041524A2 (en) 2023-03-23
CL2024003713A1 (es) 2025-04-21
IL311344A (en) 2024-05-01
JP2024534947A (ja) 2024-09-26
US20240400661A1 (en) 2024-12-05
US20240400660A1 (en) 2024-12-05
EP4401770A2 (en) 2024-07-24
CL2024000753A1 (es) 2024-09-23
US12358974B2 (en) 2025-07-15
US20250084156A1 (en) 2025-03-13
AR127054A1 (es) 2023-12-13
KR20240055758A (ko) 2024-04-29
US12351624B2 (en) 2025-07-08
CA3230055A1 (en) 2023-03-23
US12077578B2 (en) 2024-09-03
US20240400662A1 (en) 2024-12-05
US12358975B2 (en) 2025-07-15
CN117915952A (zh) 2024-04-19
MX2024002970A (es) 2024-03-27

Similar Documents

Publication Publication Date Title
US12358974B2 (en) Compositions and methods for treating synucleinopathies
JP7235770B2 (ja) 高濃度vegf受容体融合タンパク質を含む製剤
JP2019189633A (ja) 安定な二重可変ドメイン免疫グロブリンタンパク質製剤
EP3397281A1 (en) Buffered formulations of bevacizumab
TWI802882B (zh) 包含抗IL-23p19抗體的製劑、其製備方法和用途
AU2025226774A1 (en) Extended, high dose VEGF antagonist regimens for treatment of angiogenic eye disorders
WO2020173431A2 (zh) 包含抗cd47抗体的制剂及其制备方法和用途
JP2024528724A (ja) 抗pd-1抗体医薬組成物及びその使用
JP2026048712A (ja) 第XI/XIa因子抗体の医薬製剤および投薬レジメン
JP2022519796A (ja) 抗pcsk9抗体を含む安定製剤
US20250282855A1 (en) Compositions and methods for treating multiple system atrophy (msa)
TWI771335B (zh) 穩定藥學調配物
WO2025255300A1 (en) FORMULATIONS FOR ANTI-N3pGlu AMYLOID BETA ANTIBODIES
JP2025534054A (ja) 抗tigit抗体を含む製剤及びその使用方法
CN115812079A (zh) 使用白细胞介素-17(il-17)拮抗剂治疗甲状腺眼病和格雷夫斯眼眶病的方法
NZ748681A (en) Anti-cd19 antibody formulations