CU20190015A7 - Formulaciones de anticuerpos inhibidores de masp-2 altamente concentrados, de baja viscosidad y composiciones farmacéuticas que las comprenden - Google Patents

Formulaciones de anticuerpos inhibidores de masp-2 altamente concentrados, de baja viscosidad y composiciones farmacéuticas que las comprenden

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Publication number
CU20190015A7
CU20190015A7 CU2019000015A CU20190015A CU20190015A7 CU 20190015 A7 CU20190015 A7 CU 20190015A7 CU 2019000015 A CU2019000015 A CU 2019000015A CU 20190015 A CU20190015 A CU 20190015A CU 20190015 A7 CU20190015 A7 CU 20190015A7
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CU
Cuba
Prior art keywords
masp
low viscosity
composition
pharmaceutical compositions
antibody formulations
Prior art date
Application number
CU2019000015A
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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Filing date
Publication date
Application filed by Omeros Corp filed Critical Omeros Corp
Publication of CU20190015A7 publication Critical patent/CU20190015A7/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
    • 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, ***e
    • 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)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (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)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Immunology (AREA)
  • Diabetes (AREA)
  • Dermatology (AREA)
  • Biophysics (AREA)
  • Hematology (AREA)
  • Genetics & Genomics (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

<p>La presente invención se refiere a formulaciones de anticuerpos inhibidores de MASP-2 estables, de alta concentración y de baja viscosidad que comprenden una solución acuosa que comprende un sistema tampón que tiene un pH de 5.0 a 7.0 y un anticuerpo monoclonal o fragmento del mismo que se une específicamente a MASP-2 humano a una concentración de aproximadamente 50mg/ml hasta aproximadamente 250 mg/ml; en donde la formulación tiene una viscosidad de entre 2 y 50 centipose y en donde la formulación es estable cuando se almacena entre 2 ºC y 8 ºC durante al menos un mes.</p>
CU2019000015A 2016-08-31 2017-08-30 Formulaciones de anticuerpos inhibidores de masp-2 altamente concentrados, de baja viscosidad y composiciones farmacéuticas que las comprenden CU20190015A7 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201662382156P 2016-08-31 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
CU20190015A7 true CU20190015A7 (es) 2019-11-04

Family

ID=61301617

Family Applications (1)

Application Number Title Priority Date Filing Date
CU2019000015A CU20190015A7 (es) 2016-08-31 2017-08-30 Formulaciones de anticuerpos inhibidores de masp-2 altamente concentrados, de baja viscosidad y composiciones farmacéuticas que las comprenden

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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WO2014141149A1 (en) 2013-03-15 2014-09-18 Glaxosmithkline Intellectual Property (No.2) Limited Formulations with reduced viscosity
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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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Also Published As

Publication number Publication date
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
PE20190469A1 (es) 2019-04-04
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
JP7197623B2 (ja) 2022-12-27
MY189411A (en) 2022-02-10
TW201944983A (zh) 2019-12-01
AR109494A1 (es) 2018-12-12

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