PE20190469A1 - Formulaciones, kits y metodos de anticuerpos inhibidores de masp-2 de baja viscosidad altamente concentrados - Google Patents

Formulaciones, kits y metodos de anticuerpos inhibidores de masp-2 de baja viscosidad altamente concentrados

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Publication number
PE20190469A1
PE20190469A1 PE2019000408A PE2019000408A PE20190469A1 PE 20190469 A1 PE20190469 A1 PE 20190469A1 PE 2019000408 A PE2019000408 A PE 2019000408A PE 2019000408 A PE2019000408 A PE 2019000408A PE 20190469 A1 PE20190469 A1 PE 20190469A1
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PE
Peru
Prior art keywords
masp
amino acid
formulation
antibodies
variable region
Prior art date
Application number
PE2019000408A
Other languages
English (en)
Inventor
Gregory A Demopulos
Kenneth M Ferguson
William Joseph Lambert
John Steven Whitaker
Original Assignee
Omeros Corp
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Publication date
Application filed by Omeros Corp filed Critical Omeros Corp
Publication of PE20190469A1 publication Critical patent/PE20190469A1/es

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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
    • 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
    • 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
    • A61K9/08Solutions
    • 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
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    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • 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)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (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)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Immunology (AREA)
  • Biophysics (AREA)
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  • Diabetes (AREA)
  • Genetics & Genomics (AREA)
  • Psychiatry (AREA)
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  • Mycology (AREA)
  • Endocrinology (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

Se refiere a una formulacion estable y baja viscosidad de anticuerpos inhibidores de MASP-2 (serina proteasa -2 asociada a la lectina de union a manano) que comprende: (a) una solucion acuosa compuesta por un sistema de tampon de citrato o histidina con un pH de 5 a 7; (b) un anticuerpo monoclonal que se une especificamente al MASP-2 humano en una concentracion de 50mg/mL a 250 mg/mL, cuyo anticuerpo comprende: i) region variable de cadena pesada que comprende la secuencia de aminoacidos SEQ ID NO: 2, y ii) una region variable de cadena ligera que comprende la secuencia de aminoacidos SEQ ID NO: 3; y (c) un agente modificador de tonicidad es un aminoacido con una cadena lateral cargada negativamente, como el glutamato, entre otros; en cantidad suficiente para que la formulacion sea hipertonica. Dicha formulacion es util para inhibir los efectos adversos de la activacion del complemento dependiente de MASP-2.
PE2019000408A 2016-08-31 2017-08-30 Formulaciones, kits y metodos de anticuerpos inhibidores de masp-2 de baja viscosidad altamente concentrados PE20190469A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US201662382156P 2016-08-31 2016-08-31

Publications (1)

Publication Number Publication Date
PE20190469A1 true PE20190469A1 (es) 2019-04-04

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Family Applications (1)

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PE2019000408A PE20190469A1 (es) 2016-08-31 2017-08-30 Formulaciones, kits y metodos de anticuerpos inhibidores de masp-2 de baja viscosidad altamente concentrados

Country Status (29)

Country Link
US (2) US11628217B2 (es)
EP (1) EP3506886B1 (es)
JP (2) JP6864747B2 (es)
KR (2) KR20190043161A (es)
CN (3) CN116327917A (es)
AR (1) AR109494A1 (es)
AU (2) AU2017321605B2 (es)
BR (1) BR112019003479A2 (es)
CA (1) CA3035252C (es)
CL (1) CL2019000508A1 (es)
CO (1) CO2019002239A2 (es)
CR (1) CR20190150A (es)
CU (1) CU20190015A7 (es)
EA (1) EA201990598A1 (es)
EC (1) ECSP19021312A (es)
GE (1) GEP20217252B (es)
IL (1) IL265071B2 (es)
JO (1) JOP20170170B1 (es)
MA (1) MA46109A (es)
MX (1) MX2019002338A (es)
MY (1) MY189411A (es)
PE (1) PE20190469A1 (es)
PH (1) PH12019500365A1 (es)
SG (2) SG10202100697PA (es)
TW (2) TWI719245B (es)
UA (1) UA122733C2 (es)
UY (1) UY37391A (es)
WO (1) WO2018045054A1 (es)
ZA (1) ZA201901891B (es)

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AU2017205453B2 (en) * 2016-01-05 2020-03-12 Omeros Corporation Methods for inhibiting fibrosis in a subject in need thereof
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
BR112020003632A2 (pt) * 2017-08-25 2020-10-27 Omeros Corporation método de tratamento de um indivíduo que sofre ou corre risco de desenvolver ahus
CA3129901A1 (en) 2019-02-18 2020-08-27 Eli Lilly And Company Therapeutic antibody formulation
WO2021013689A1 (en) * 2019-07-19 2021-01-28 Ichnos Sciences SA Lyophilized antibody formulation
CA3159159A1 (en) 2019-12-04 2021-06-10 Neil S. Cutshall Masp-2 inhibitors and methods of use
AU2020398241A1 (en) 2019-12-04 2022-06-30 Omeros Corporation MASP-2 inhibitors and methods of use
EP4069238A1 (en) 2019-12-04 2022-10-12 Omeros Corporation Masp-2 inhibitors and methods of use
IL293551A (en) 2019-12-04 2022-08-01 Omeros Corp 2-masp inhibitor compounds, preparations containing them and their uses
KR20230042744A (ko) 2020-07-31 2023-03-29 알라맵 테라퓨틱스, 인크. 항-코넥신 항체 제제
US20230406920A1 (en) * 2020-10-22 2023-12-21 Allakos Inc. Anti-siglec-8 antibody formulations
CA3221859A1 (en) * 2021-06-08 2022-12-15 Xiaowu Liu Anti-masp-2 antibody and use thereof

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GEP20247583B (en) 2015-11-09 2024-01-10 Univ Leicester Methods for treating condi tions associated with masp-2 dependent complement activation
AU2017205453B2 (en) 2016-01-05 2020-03-12 Omeros Corporation Methods for inhibiting fibrosis in a subject in need thereof
US20170253667A1 (en) 2016-01-05 2017-09-07 University Of Leicester Methods for inhibiting fibrosis in a subject in need thereof
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UY37391A (es) 2018-02-28
JP6864747B2 (ja) 2021-04-28
JP2019531341A (ja) 2019-10-31
BR112019003479A2 (pt) 2019-05-21
UA122733C2 (uk) 2020-12-28
EP3506886A1 (en) 2019-07-10
AU2017321605A1 (en) 2019-02-07
TWI730310B (zh) 2021-06-11
MA46109A (fr) 2019-07-10
EP3506886B1 (en) 2024-05-22
CA3035252A1 (en) 2018-03-08
US20180153988A1 (en) 2018-06-07
KR20210135618A (ko) 2021-11-15
PH12019500365A1 (en) 2019-11-04
ECSP19021312A (es) 2019-04-30
CO2019002239A2 (es) 2019-03-18
JOP20170170A1 (ar) 2019-01-30
GEP20217252B (en) 2021-05-13
JP2021105033A (ja) 2021-07-26
CN116327695A (zh) 2023-06-27
EA201990598A1 (ru) 2019-07-31
US11628217B2 (en) 2023-04-18
IL265071A (es) 2019-04-30
KR102444154B1 (ko) 2022-09-16
SG10202100697PA (en) 2021-02-25
EP3506886A4 (en) 2019-10-09
SG11201901444PA (en) 2019-03-28
CR20190150A (es) 2019-05-14
CN109890367B (zh) 2022-08-30
AU2020277135B2 (en) 2023-11-02
IL265071B2 (en) 2023-12-01
NZ751988A (en) 2021-09-24
AU2020277135A1 (en) 2020-12-24
CN116327917A (zh) 2023-06-27
CL2019000508A1 (es) 2019-06-28
AU2017321605B2 (en) 2020-10-08
TWI719245B (zh) 2021-02-21
CA3035252C (en) 2021-08-10
JOP20170170B1 (ar) 2022-09-15
US20230226178A1 (en) 2023-07-20
MX2019002338A (es) 2019-08-16
CN109890367A (zh) 2019-06-14
TW201811365A (zh) 2018-04-01
ZA201901891B (en) 2019-12-18
IL265071B1 (en) 2023-08-01
KR20190043161A (ko) 2019-04-25
WO2018045054A1 (en) 2018-03-08
CU20190015A7 (es) 2019-11-04
JP7197623B2 (ja) 2022-12-27
MY189411A (en) 2022-02-10
TW201944983A (zh) 2019-12-01
AR109494A1 (es) 2018-12-12

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