CA2939507A1 - Methods for treating patients with hypercholesterolemia that is not adequately controlled by moderate-dose statin therapy - Google Patents

Methods for treating patients with hypercholesterolemia that is not adequately controlled by moderate-dose statin therapy Download PDF

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Publication number
CA2939507A1
CA2939507A1 CA2939507A CA2939507A CA2939507A1 CA 2939507 A1 CA2939507 A1 CA 2939507A1 CA 2939507 A CA2939507 A CA 2939507A CA 2939507 A CA2939507 A CA 2939507A CA 2939507 A1 CA2939507 A1 CA 2939507A1
Authority
CA
Canada
Prior art keywords
dose
patient
antibody
pcsk9
ldl
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.)
Abandoned
Application number
CA2939507A
Other languages
English (en)
French (fr)
Inventor
Robert C. Pordy
William J. Sasiela
Joyce B. Harp
Corinne Hanotin
Laurence BESSAC
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.)
Sanofi Biotechnology SAS
Regeneron Pharmaceuticals Inc
Original Assignee
Sanofi Biotechnology SAS
Regeneron 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 Sanofi Biotechnology SAS, Regeneron Pharmaceuticals Inc filed Critical Sanofi Biotechnology SAS
Publication of CA2939507A1 publication Critical patent/CA2939507A1/en
Abandoned legal-status Critical Current

Links

Classifications

    • 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
    • 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
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/06—Antihyperlipidemics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/40—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against enzymes
    • 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
    • A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Endocrinology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Diabetes (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Urology & Nephrology (AREA)
  • Vascular Medicine (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
CA2939507A 2014-02-14 2015-02-12 Methods for treating patients with hypercholesterolemia that is not adequately controlled by moderate-dose statin therapy Abandoned CA2939507A1 (en)

Applications Claiming Priority (11)

Application Number Priority Date Filing Date Title
US201461939857P 2014-02-14 2014-02-14
US61/939,857 2014-02-14
US201462000162P 2014-05-19 2014-05-19
US62/000,162 2014-05-19
US201462025094P 2014-07-16 2014-07-16
US62/025,094 2014-07-16
US201462052227P 2014-09-18 2014-09-18
US62/052,227 2014-09-18
EP14306729 2014-10-29
EP14306729.6 2014-10-29
PCT/US2015/015633 WO2015123423A2 (en) 2014-02-14 2015-02-12 Methods for treating patients with hypercholesterolemia that is not adequately controlled by moderate-dose statin therapy

Publications (1)

Publication Number Publication Date
CA2939507A1 true CA2939507A1 (en) 2015-08-20

Family

ID=51870958

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2939507A Abandoned CA2939507A1 (en) 2014-02-14 2015-02-12 Methods for treating patients with hypercholesterolemia that is not adequately controlled by moderate-dose statin therapy

Country Status (10)

Country Link
US (2) US20150231236A1 (enExample)
EP (1) EP3104879A2 (enExample)
JP (1) JP2017506626A (enExample)
KR (1) KR20160115939A (enExample)
CN (1) CN106029096A (enExample)
AU (1) AU2015217118A1 (enExample)
CA (1) CA2939507A1 (enExample)
EA (1) EA201691320A1 (enExample)
MX (1) MX2016010504A (enExample)
WO (1) WO2015123423A2 (enExample)

Families Citing this family (23)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20130064834A1 (en) 2008-12-15 2013-03-14 Regeneron Pharmaceuticals, Inc. Methods for treating hypercholesterolemia using antibodies to pcsk9
JO3672B1 (ar) 2008-12-15 2020-08-27 Regeneron Pharma أجسام مضادة بشرية عالية التفاعل الكيماوي بالنسبة لإنزيم سبتيليسين كنفرتيز بروبروتين / كيكسين نوع 9 (pcsk9).
CA2825778A1 (en) * 2011-01-28 2012-08-02 Sanofi Pharmaceutical compositions comprising human antibodies to pcsk9
AR087305A1 (es) 2011-07-28 2014-03-12 Regeneron Pharma Formulaciones estabilizadas que contienen anticuerpos anti-pcsk9, metodo de preparacion y kit
ES2773111T3 (es) 2011-09-16 2020-07-09 Regeneron Pharma Inhibidor de la proproteína convertasa subtilisina/kexina 9 (PCSK9) para su uso en la reducción de los niveles de lipoproteína (a)
US9255154B2 (en) 2012-05-08 2016-02-09 Alderbio Holdings, Llc Anti-PCSK9 antibodies and use thereof
US10058630B2 (en) 2012-10-22 2018-08-28 Concievalve, Llc Methods for inhibiting stenosis, obstruction, or calcification of a stented heart valve or bioprosthesis
US20140257473A1 (en) * 2012-10-22 2014-09-11 Nalini Marie Rajamannan Methods for inhibiting stenosis, obstruction, or calcification of a stented heart valve or bioprosthesis
US10111953B2 (en) 2013-05-30 2018-10-30 Regeneron Pharmaceuticals, Inc. Methods for reducing remnant cholesterol and other lipoprotein fractions by administering an inhibitor of proprotein convertase subtilisin kexin-9 (PCSK9)
TW201534324A (zh) 2013-06-07 2015-09-16 Sanofi Sa 藉由投與ｐｃｓｋ９抑制劑抑制動脈粥狀硬化的方法
US10428157B2 (en) 2013-11-12 2019-10-01 Sanofi Biotechnology Dosing regimens for use with PCSK9 inhibitors
WO2015176031A2 (en) 2014-05-15 2015-11-19 Incube Labs, Llc Pharmaceutical compositions and methods for fabrication of solid masses comprising polypeptides and/or proteins
US20230374155A1 (en) * 2014-05-15 2023-11-23 Rani Therapeutics, Llc Pcsk9 antibody preparations for delivery into a lumen of the intestinal tract using a swallowable drug delivery device
US10689460B2 (en) * 2014-05-15 2020-06-23 Incube Labs, Llc PCSK9 antibody preparations for delivery into a lumen of the intestinal tract using a swallowable drug delivery device
US20170198059A1 (en) * 2014-07-14 2017-07-13 Amgen Inc. Crystalline antibody formulations
KR20230074283A (ko) 2014-07-16 2023-05-26 사노피 바이오테크놀로지 이형접합성 가족성 고콜레스테롤혈증(heFH) 환자의 치료방법
EA201890519A1 (ru) 2015-08-18 2018-07-31 Ридженерон Фармасьютикалз, Инк. Ингибирующие антитела против pcsk9 для лечения пациентов с гиперлипидемией, подвергающихся аферезу липопротеинов
AU2016320867B2 (en) * 2015-09-08 2023-03-30 Rani Therapeutics, Llc PCSK9 antibody preparations for delivery into a lumen of the intestinal tract using a swallowable drug delivery device
US10939164B2 (en) 2016-05-10 2021-03-02 Rovi Guides, Inc. Method and system for transferring an interactive feature to another device
US20190321515A1 (en) * 2016-06-27 2019-10-24 ConcieValve LLC Improved methods for inhibiting stenosis, obstruction, or calcification of a stented heart valve or bioprosthesis
US11325945B2 (en) 2017-04-12 2022-05-10 Cadila Healthcare Limited Peptide based PCSK9 vaccine
GB201720162D0 (en) 2017-12-04 2018-01-17 Univ Oxford Innovation Ltd Method
WO2020150473A2 (en) 2019-01-18 2020-07-23 Dogma Therapeutics, Inc. Pcsk9 inhibitors and methods of use thereof

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6596541B2 (en) 2000-10-31 2003-07-22 Regeneron Pharmaceuticals, Inc. Methods of modifying eukaryotic cells
JO3672B1 (ar) 2008-12-15 2020-08-27 Regeneron Pharma أجسام مضادة بشرية عالية التفاعل الكيماوي بالنسبة لإنزيم سبتيليسين كنفرتيز بروبروتين / كيكسين نوع 9 (pcsk9).
CA2825778A1 (en) * 2011-01-28 2012-08-02 Sanofi Pharmaceutical compositions comprising human antibodies to pcsk9
ES2773111T3 (es) * 2011-09-16 2020-07-09 Regeneron Pharma Inhibidor de la proproteína convertasa subtilisina/kexina 9 (PCSK9) para su uso en la reducción de los niveles de lipoproteína (a)
US9255154B2 (en) * 2012-05-08 2016-02-09 Alderbio Holdings, Llc Anti-PCSK9 antibodies and use thereof
WO2013177536A2 (en) * 2012-05-25 2013-11-28 Catabasis Pharmaceuticals, Inc. Methods of lowering proprotein convertase subtilisin/kexin type 9 (pcsk9)

Also Published As

Publication number Publication date
AU2015217118A1 (en) 2016-08-18
EP3104879A2 (en) 2016-12-21
CN106029096A (zh) 2016-10-12
WO2015123423A2 (en) 2015-08-20
WO2015123423A3 (en) 2015-10-08
MX2016010504A (es) 2016-12-09
US20180296672A1 (en) 2018-10-18
US20150231236A1 (en) 2015-08-20
KR20160115939A (ko) 2016-10-06
EA201691320A1 (ru) 2016-11-30
JP2017506626A (ja) 2017-03-09

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Legal Events

Date Code Title Description
EEER Examination request

Effective date: 20200204

FZDE Discontinued

Effective date: 20220603