AU2020401102A1 - Anti-C5 antibody for the treatment of neuromyelitis optica spectrum disorder - Google Patents

Anti-C5 antibody for the treatment of neuromyelitis optica spectrum disorder Download PDF

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Publication number
AU2020401102A1
AU2020401102A1 AU2020401102A AU2020401102A AU2020401102A1 AU 2020401102 A1 AU2020401102 A1 AU 2020401102A1 AU 2020401102 A AU2020401102 A AU 2020401102A AU 2020401102 A AU2020401102 A AU 2020401102A AU 2020401102 A1 AU2020401102 A1 AU 2020401102A1
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AU
Australia
Prior art keywords
antibody
patient
ravulizumab
dose
study
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
AU2020401102A
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English (en)
Inventor
Kerstin ALLEN
Fanny O'BRIEN
Stephan ORTIZ
Marcus YOUNTZ
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.)
Alexion Pharmaceuticals Inc
Original Assignee
Alexion Pharmaceuticals Inc
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 Alexion Pharmaceuticals Inc filed Critical Alexion Pharmaceuticals Inc
Publication of AU2020401102A1 publication Critical patent/AU2020401102A1/en
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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/4353—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/436—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a six-membered ring having oxygen as a ring hetero atom, e.g. rapamycin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A61K31/52—Purines, e.g. adenine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/535—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
    • A61K31/5375—1,4-Oxazines, e.g. morpholine
    • A61K31/5377—1,4-Oxazines, e.g. morpholine not condensed and containing further heterocyclic rings, e.g. timolol
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • 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
    • 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
    • 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
    • A61K2039/55—Medicinal preparations containing antigens or antibodies characterised by the host/recipient, e.g. newborn with maternal antibodies
    • 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
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52—Constant or Fc region; Isotype
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565—Complementarity determining region [CDR]
    • 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
    • C07K2317/92—Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
    • 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
    • C07K2317/94—Stability, 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)
  • Organic Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Immunology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Neurosurgery (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Microbiology (AREA)
  • Endocrinology (AREA)
  • Transplantation (AREA)
  • Mycology (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)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
AU2020401102A 2019-12-09 2020-12-08 Anti-C5 antibody for the treatment of neuromyelitis optica spectrum disorder Pending AU2020401102A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201962945644P 2019-12-09 2019-12-09
US62/945,644 2019-12-09
PCT/US2020/063781 WO2021118999A1 (en) 2019-12-09 2020-12-08 Anti-c5 antibody for the treatment of neuromyelitis optica spectrum disorder

Publications (1)

Publication Number Publication Date
AU2020401102A1 true AU2020401102A1 (en) 2022-07-21

Family

ID=74046204

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2020401102A Pending AU2020401102A1 (en) 2019-12-09 2020-12-08 Anti-C5 antibody for the treatment of neuromyelitis optica spectrum disorder

Country Status (11)

Country Link
US (1) US12612451B2 (https=)
EP (1) EP4073110A1 (https=)
JP (2) JP7789672B2 (https=)
KR (1) KR20220110827A (https=)
CN (2) CN119548622A (https=)
AU (1) AU2020401102A1 (https=)
BR (1) BR112022011280A2 (https=)
CA (1) CA3161271A1 (https=)
CO (1) CO2022009246A2 (https=)
MX (1) MX2022007116A (https=)
WO (1) WO2021118999A1 (https=)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA3251727A1 (en) * 2022-05-04 2023-11-09 Alexion Pharmaceuticals, Inc. COMPOSITIONS AND METHODS FOR THE TREATMENT OF A DISORDER ON THE SPECTRUM OF OPTICAL NEUROMYELITIS
WO2025221479A1 (en) * 2024-04-16 2025-10-23 Alexion Pharmaceuticals, Inc. Biomarkers for monitoring effective treatment of neuromyelitis optica spectrum disorder (nmosd) with complement component c5 inhibitors

Family Cites Families (23)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5135916A (en) 1989-06-12 1992-08-04 Oklahoma Medical Research Foundation Inhibition of complement mediated inflammatory response
US6074642A (en) 1994-05-02 2000-06-13 Alexion Pharmaceuticals, Inc. Use of antibodies specific to human complement component C5 for the treatment of glomerulonephritis
US8367805B2 (en) 2004-11-12 2013-02-05 Xencor, Inc. Fc variants with altered binding to FcRn
US20090220508A1 (en) 2006-03-15 2009-09-03 Alexion Pharmaceuticals, Inc. Treatment Of Paroxysmal Nocturnal Hemoglobinuria Patients By An Inhibitor Of Complement
PY09026846A (es) 2008-08-05 2015-09-01 Novartis Ag Composiciones y métodos para anticuerpos que se dirigen a la proteína de complemento c5
CA2742802C (en) 2008-11-10 2019-11-26 Alexion Pharmaceuticals, Inc. Methods and compositions for treating complement-associated disorders
JO3437B1 (ar) * 2009-10-30 2019-10-20 Esai R & D Man Co Ltd أجسام مضادة محسنة مضادة للفراكتالكين البشري واستخداماتها
BR112012027917A2 (pt) 2010-04-30 2017-11-28 Alexion Pharma Inc anticorpos que apresentam reduzida imunogenicidade em um indivíduo humano
MX340696B (es) * 2010-04-30 2016-07-21 Alexion Pharma Inc Anticuerpos anti-c5a y metodos para usar los anticuerpos.
TW201241008A (en) * 2010-10-01 2012-10-16 Alexion Pharma Inc Polypeptides that bind to human complement component C5
IL288931B2 (en) 2013-03-14 2025-05-01 Alnylam Pharmaceuticals Inc Compositions comprising a complementary portion of C5 IRNA and methods of using them
SI3011345T1 (sl) 2013-08-07 2017-12-29 Alexion Pharmaceuticals, Inc. Biomarkerski proteini za atipični hemolitični uremični sindrom (ahus)
NZ631007A (en) 2014-03-07 2015-10-30 Alexion Pharma Inc Anti-c5 antibodies having improved pharmacokinetics
BR112017011235A2 (pt) 2014-12-19 2018-02-06 Chugai Pharmaceutical Co Ltd anticorpos anti-c5 e métodos de uso
EP3313437A1 (en) * 2015-06-26 2018-05-02 Alexion Pharmaceuticals, Inc. A method for treating a patient in compliance with vaccination with eculizumab or an eculizumab variant
EP3402816A1 (en) * 2016-01-11 2018-11-21 Alexion Pharmaceuticals, Inc. Dosage and administration of anti-c5 antibodies for treatment
CN116769024A (zh) 2016-06-14 2023-09-19 瑞泽恩制药公司 抗c5抗体及其用途
ES2999550T3 (en) * 2017-03-31 2025-02-26 Alexion Pharma Inc Method for simultaneous quantification of alxn1210 and eculizumab in human serum or urine
US20200095307A1 (en) 2018-09-21 2020-03-26 Alexion Pharmaceuticals, Inc. Compositions and methods for the treatment of neuromyelitis optica
EP4135837A1 (en) 2020-04-16 2023-02-22 Assistance Publique, Hopitaux De Paris Methods for treating a complement mediated disorder caused by viruses
CN116437913A (zh) 2020-09-23 2023-07-14 艾其林医药公司 用于治疗补体介导的病症的药物化合物
CA3251727A1 (en) 2022-05-04 2023-11-09 Alexion Pharmaceuticals, Inc. COMPOSITIONS AND METHODS FOR THE TREATMENT OF A DISORDER ON THE SPECTRUM OF OPTICAL NEUROMYELITIS
WO2025221479A1 (en) 2024-04-16 2025-10-23 Alexion Pharmaceuticals, Inc. Biomarkers for monitoring effective treatment of neuromyelitis optica spectrum disorder (nmosd) with complement component c5 inhibitors

Also Published As

Publication number Publication date
CA3161271A1 (en) 2021-06-17
JP2023504209A (ja) 2023-02-01
CN119548622A (zh) 2025-03-04
CO2022009246A2 (es) 2022-07-29
KR20220110827A (ko) 2022-08-09
US20230043034A1 (en) 2023-02-09
MX2022007116A (es) 2022-07-11
WO2021118999A1 (en) 2021-06-17
JP7789672B2 (ja) 2025-12-22
JP2025084932A (ja) 2025-06-03
CN114867747A (zh) 2022-08-05
US12612451B2 (en) 2026-04-28
EP4073110A1 (en) 2022-10-19
BR112022011280A2 (pt) 2022-09-06

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