BR112019003479A2 - formulação e composição farmacêuticas, recipiente vedado, dispositivo de administração subcutânea, kit, forma de dosagem unitária farmacêutica, e, método para tratamento de um indivíduo sofrendo de uma doença ou de um distúrbio associados ao complemento dependente de masp-2. - Google Patents

formulação e composição farmacêuticas, recipiente vedado, dispositivo de administração subcutânea, kit, forma de dosagem unitária farmacêutica, e, método para tratamento de um indivíduo sofrendo de uma doença ou de um distúrbio associados ao complemento dependente de masp-2.

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Publication number
BR112019003479A2
BR112019003479A2 BR112019003479-0A BR112019003479A BR112019003479A2 BR 112019003479 A2 BR112019003479 A2 BR 112019003479A2 BR 112019003479 A BR112019003479 A BR 112019003479A BR 112019003479 A2 BR112019003479 A2 BR 112019003479A2
Authority
BR
Brazil
Prior art keywords
masp
disorder
kit
treating
composition
Prior art date
Application number
BR112019003479-0A
Other languages
English (en)
Inventor
A. Demopulos Gregory
M. Ferguson Kenneth
Joseph Lambert William
Steven Whitaker John
Original Assignee
Omeros Corporation
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 Omeros Corporation filed Critical Omeros Corporation
Publication of BR112019003479A2 publication Critical patent/BR112019003479A2/pt

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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
    • A61K39/39533Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • 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
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • A61P13/12Drugs for disorders of the urinary system of the kidneys
    • 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
    • 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
    • A61P25/26Psychostimulants, e.g. nicotine, cocaine
    • 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
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00Drugs for disorders of the senses
    • A61P27/02Ophthalmic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/02Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/06Antianaemics
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/40Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against enzymes
    • 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
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52Constant or Fc region; Isotype
    • C07K2317/53Hinge
    • 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

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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)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Immunology (AREA)
  • Dermatology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Psychiatry (AREA)
  • Endocrinology (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Urology & Nephrology (AREA)
  • Psychology (AREA)
  • Hospice & Palliative Care (AREA)
  • Ophthalmology & Optometry (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)

Abstract

a presente invenção refere-se a formulações estáveis, de alta concentração e baixa viscosidade de anticorpos inibitórios de masp-2, a kits compreendendo as formulações e a métodos terapêuticos usando as formulações e kits para a inibição dos efeitos adversos da ativação de complemento dependente de masp-2.
BR112019003479-0A 2016-08-31 2017-08-30 formulação e composição farmacêuticas, recipiente vedado, dispositivo de administração subcutânea, kit, forma de dosagem unitária farmacêutica, e, método para tratamento de um indivíduo sofrendo de uma doença ou de um distúrbio associados ao complemento dependente de masp-2. BR112019003479A2 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201662382156P 2016-08-31 2016-08-31
US62/382,156 2016-08-31
PCT/US2017/049415 WO2018045054A1 (en) 2016-08-31 2017-08-30 Highly concentrated low viscosity masp-2 inhibitory antibody formulations, kits, and methods

Publications (1)

Publication Number Publication Date
BR112019003479A2 true BR112019003479A2 (pt) 2019-05-21

Family

ID=61301617

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112019003479-0A BR112019003479A2 (pt) 2016-08-31 2017-08-30 formulação e composição farmacêuticas, recipiente vedado, dispositivo de administração subcutânea, kit, forma de dosagem unitária farmacêutica, e, método para tratamento de um indivíduo sofrendo de uma doença ou de um distúrbio associados ao complemento dependente de masp-2.

Country Status (29)

Country Link
US (2) US11628217B2 (pt)
EP (1) EP3506886B1 (pt)
JP (2) JP6864747B2 (pt)
KR (2) KR102444154B1 (pt)
CN (3) CN116327695A (pt)
AR (1) AR109494A1 (pt)
AU (2) AU2017321605B2 (pt)
BR (1) BR112019003479A2 (pt)
CA (1) CA3035252C (pt)
CL (1) CL2019000508A1 (pt)
CO (1) CO2019002239A2 (pt)
CR (1) CR20190150A (pt)
CU (1) CU20190015A7 (pt)
EA (1) EA201990598A1 (pt)
EC (1) ECSP19021312A (pt)
GE (1) GEP20217252B (pt)
IL (1) IL265071B2 (pt)
JO (1) JOP20170170B1 (pt)
MA (1) MA46109A (pt)
MX (2) MX2019002338A (pt)
MY (1) MY189411A (pt)
PE (1) PE20190469A1 (pt)
PH (1) PH12019500365A1 (pt)
SG (2) SG11201901444PA (pt)
TW (2) TWI730310B (pt)
UA (1) UA122733C2 (pt)
UY (1) UY37391A (pt)
WO (1) WO2018045054A1 (pt)
ZA (1) ZA201901891B (pt)

Families Citing this family (14)

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KR102564616B1 (ko) * 2016-01-05 2023-08-08 유니버시티 오브 레스터 필요로 하는 대상체에서 섬유증의 억제 방법
JOP20170170B1 (ar) * 2016-08-31 2022-09-15 Omeros Corp صيغ لجسم مضاد تثبيطية لـ masp-2 بتركيز عالي ولزوجة منخفضة وأطقم، وطرق
JOP20190068A1 (ar) * 2016-10-13 2019-04-01 Omeros Corp طرق لتقليل البول البروتيني في خاضع بشري يعاني من الاعتلال الكلوي a الناتج عن الجلوبيولين المناعي
MA49960A (fr) * 2017-08-25 2021-06-02 Omeros Corp Formulations d'anticorps inhibiteurs de masp-2 hautement concentrées à faible viscosité, kits et méthodes de traitement de sujets souffrant d'un syndrome hémolytique atypique
MA55033A (fr) 2019-02-18 2021-12-29 Lilly Co Eli Formulation d'anticorps thérapeutique
EP3999537A1 (en) * 2019-07-19 2022-05-25 Ichnos Sciences SA Lyophilized antibody formulation
CA3159167A1 (en) 2019-12-04 2021-06-10 Neil S. Cutshall Masp-2 inhibitors and methods of use
CN115052604A (zh) 2019-12-04 2022-09-13 奥默罗斯公司 Masp-2抑制剂和使用方法
BR112022010895A2 (pt) 2019-12-04 2022-09-06 Omeros Corp Composto, composição farmacêutica, e, método para tratar uma doença ou distúrbio associado à serina protease-2 associada à lectina de ligação ao manan
CA3159159A1 (en) 2019-12-04 2021-06-10 Neil S. Cutshall Masp-2 inhibitors and methods of use
IL300245A (en) 2020-07-31 2023-03-01 Alamab Therapeutics Inc Anti-connexin antibody formulations
WO2022087610A1 (en) * 2020-10-22 2022-04-28 Allakos Inc. Anti-siglec-8 antibody formulations
BR112023025596A2 (pt) * 2021-06-08 2024-02-27 Jiangxi Jemincare Group Co Ltd Anticorpo anti-masp-2 e uso do mesmo
WO2024118840A1 (en) 2022-11-30 2024-06-06 Omeros Corporation Fused pyrimidines as masp-2 inhibitors

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US8840893B2 (en) 2004-06-10 2014-09-23 Omeros Corporation Methods for treating conditions associated with MASP-2 dependent complement activation
AU2006330858A1 (en) 2005-12-21 2007-07-05 Wyeth Protein formulations with reduced viscosity and uses thereof
CN102781471B (zh) 2009-10-16 2016-10-12 奥默罗斯公司 通过抑制masp-2依赖性补体活化治疗弥散性血管内凝血的方法
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RU2662563C2 (ru) 2011-04-08 2018-07-26 Юниверсити Оф Лестер Способы лечения состояний, связанных с masp-2 зависимой активацией комплемента
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MX347691B (es) 2011-05-04 2017-05-09 Omeros Corp Composiciones para inhibir la activacion del complemento dependiente de la masp-2.
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WO2014141149A1 (en) 2013-03-15 2014-09-18 Glaxosmithkline Intellectual Property (No.2) Limited Formulations with reduced viscosity
HUE051746T2 (hu) * 2013-10-17 2021-03-29 Omeros Corp Eljárások MASP-2-függõ komplement aktiválással kapcsolatos állapotok kezelésére
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KR102564616B1 (ko) 2016-01-05 2023-08-08 유니버시티 오브 레스터 필요로 하는 대상체에서 섬유증의 억제 방법
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JOP20170170B1 (ar) 2016-08-31 2022-09-15 Omeros Corp صيغ لجسم مضاد تثبيطية لـ masp-2 بتركيز عالي ولزوجة منخفضة وأطقم، وطرق

Also Published As

Publication number Publication date
IL265071B2 (en) 2023-12-01
US20180153988A1 (en) 2018-06-07
KR102444154B1 (ko) 2022-09-16
AU2017321605A1 (en) 2019-02-07
CU20190015A7 (es) 2019-11-04
EP3506886B1 (en) 2024-05-22
US11628217B2 (en) 2023-04-18
TW201811365A (zh) 2018-04-01
EP3506886A1 (en) 2019-07-10
UY37391A (es) 2018-02-28
ZA201901891B (en) 2019-12-18
CN109890367A (zh) 2019-06-14
PH12019500365A1 (en) 2019-11-04
JP7197623B2 (ja) 2022-12-27
MA46109A (fr) 2019-07-10
AU2017321605B2 (en) 2020-10-08
NZ751988A (en) 2021-09-24
CO2019002239A2 (es) 2019-03-18
WO2018045054A1 (en) 2018-03-08
CA3035252A1 (en) 2018-03-08
CN116327695A (zh) 2023-06-27
AU2020277135B2 (en) 2023-11-02
TWI730310B (zh) 2021-06-11
EP3506886A4 (en) 2019-10-09
ECSP19021312A (es) 2019-04-30
IL265071B1 (en) 2023-08-01
US20230226178A1 (en) 2023-07-20
PE20190469A1 (es) 2019-04-04
EA201990598A1 (ru) 2019-07-31
IL265071A (pt) 2019-04-30
MX2023014120A (es) 2023-12-12
JP2019531341A (ja) 2019-10-31
UA122733C2 (uk) 2020-12-28
CN116327917A (zh) 2023-06-27
CR20190150A (es) 2019-05-14
SG11201901444PA (en) 2019-03-28
KR20190043161A (ko) 2019-04-25
JP6864747B2 (ja) 2021-04-28
CA3035252C (en) 2021-08-10
JP2021105033A (ja) 2021-07-26
TWI719245B (zh) 2021-02-21
AU2020277135A1 (en) 2020-12-24
JOP20170170B1 (ar) 2022-09-15
CL2019000508A1 (es) 2019-06-28
CN109890367B (zh) 2022-08-30
GEP20217252B (en) 2021-05-13
MY189411A (en) 2022-02-10
JOP20170170A1 (ar) 2019-01-30
MX2019002338A (es) 2019-08-16
AR109494A1 (es) 2018-12-12
TW201944983A (zh) 2019-12-01
KR20210135618A (ko) 2021-11-15
SG10202100697PA (en) 2021-02-25

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