WO2019231800A1 - Anticorps anti-cgrp pour le traitement des migraines liées aux menstruations - Google Patents

Anticorps anti-cgrp pour le traitement des migraines liées aux menstruations Download PDF

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Publication number
WO2019231800A1
WO2019231800A1 PCT/US2019/033651 US2019033651W WO2019231800A1 WO 2019231800 A1 WO2019231800 A1 WO 2019231800A1 US 2019033651 W US2019033651 W US 2019033651W WO 2019231800 A1 WO2019231800 A1 WO 2019231800A1
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antibody
seq
administered
human patient
migraines
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PCT/US2019/033651
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English (en)
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Sheena Aurora
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Eli Lilly And Company
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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], 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
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising 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
    • C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/34—Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues

Definitions

  • the present invention is in the field of medicine. More specifically, the present invention relates to methods and uses of antibodies directed to calcitonin gene-related peptide (CGRP) for the treatment of menstrual-related migraines.
  • CGRP calcitonin gene-related peptide
  • Migraine is a common neurologic disease that affects more than 36 million people in the Unites States, being more prevalent in females of reproductive age. Migraine without aura in more than 50% of women correlates with menstrual cycle hormonal fluctuations, and has been recognized as more severe and difficult to manage with conventional therapies around the menstrual period.
  • the present invention derives from an exploratory analysis focused on the effect of galcanezumab, an anti-human calcitonin gene-related peptide (CGRP) antibody, studied for the prevention of chronic and episodic migraine, in the incidence and severity of migraine attacks during the perimenstrual period.
  • CGRP anti-human calcitonin gene-related peptide
  • CGRP calcitonin gene-related peptide
  • Antibodies directed to calcitonin gene-related peptide (CGRP) and methods of making the same are well known and have been previously described, for example, in WO2011/156324A1.
  • CGRP or‘calcitonin gene related peptide” refers to a peptide having the sequence given in SEQ ID NO: 5.
  • Non-limiting examples of anti-human calcitonin gene related peptide (CGRP) antibodies include eptinezumab, fremanezumab, and galcanezumab.
  • the anti-human calcitonin gene related peptide (CGRP) antibody comprises a heavy chain having a heavy chain variable region having the amino acid sequence of SEQ ID NO: 2 and a light chain having a light chain variable region having the amino acid sequence of SEQ ID NO: 1.
  • the anti-human calcitonin gene related peptide (CGRP) antibody comprises a heavy chain having the amino acid sequence of SEQ ID NO: 4 and a light chain having the amino acid sequence of SEQ ID NO: 3.
  • the anti -human calcitonin gene related peptide antibody binds to an epitope on human CGRP comprising amino acids VTHRLAGLLSR of SEQ ID NO: 5, as determined by hydrogen-deuterium exchange.
  • a patient is a human who has been diagnosed as having a condition or disorder in need of treatment with an antibody or pharmaceutical composition described herein.
  • a patient is a human that is characterized as being at risk of a condition or disorder for which treatment or administration with a pharmaceutical composition described herein is indicated.
  • the term“treating” refers to processes involving a slowing, interrupting, arresting, controlling, stopping, reducing, or reversing the progression or severity of a symptom, disorder, condition, or disease, but does not necessarily involve a total elimination of all disease-related symptoms, conditions, or disorders associated with CGRP activity.
  • the term“prevention” refers to precluding, averting, obviating, forestalling, reducing the incidence of, stopping, or hindering the symptoms of a disease, disorder and/or condition. Prevention includes administration to a subject who does not exhibit symptoms of a disease, disorder, and/or condition at the time of administration.
  • the term“therapeutically effective amount” refers to the amount or dose of an anti-human calcitonin gene related peptide (CGRP) antibody in a pharmaceutical composition, which upon single or multiple dose administration to the patient, provides the desired pharmacological effect in the patient.
  • a dose can include a higher initial loading dose, followed by a lower dose.
  • A“dose” refers to a predetermined quantity of a therapeutic drug calculated to produce the desired therapeutic effect in a patient.
  • a therapeutically effective amount can be determined by the attending diagnostician.
  • the term“month,”“monthly,” or derivations thereof refers to a time period that is from 28 to 31 consecutive days.
  • the present disclosure provides a method of treating menstrual-related migraines in a human patient comprising administering a therapeutically effective amount of an anti human calcitonin gene related peptide (CGRP) antibody to the human patient in need thereof.
  • CGRP human calcitonin gene related peptide
  • the present disclosure provides a method of treating menstrual-related migraines in a human patient comprising administering a therapeutically effective amount of an anti- human calcitonin gene related peptide (CGRP) antibody to the human patient in need thereof; wherein the human patient has been diagnosed with episodic migraines prior to receiving the antibody.
  • CGRP anti- human calcitonin gene related peptide
  • the present disclosure provides a method of treating menstrual-related migraines in a human patient comprising administering a therapeutically effective amount of an anti human calcitonin gene related peptide (CGRP) antibody to the human patient in need thereof; wherein the human patient has been diagnosed with chronic migraines prior to receiving the antibody.
  • CGRP human calcitonin gene related peptide
  • the present disclosure provides a method of treating menstrual-related migraines in a human patient comprising administering a therapeutically effective amount of an anti human calcitonin gene related peptide (CGRP) antibody to the human patient in need thereof, wherein the human patient experiences auras with their menstrual-related migraines.
  • CGRP human calcitonin gene related peptide
  • the present disclosure provides a method of treating menstrual-related migraines in a human patient comprising administering a therapeutically effective amount of an anti human calcitonin gene related peptide (CGRP) antibody to the human patient in need thereof; wherein the human patient does not experience auras with their menstrual - related migraines.
  • CGRP human calcitonin gene related peptide
  • the present disclosure provides a method of treating menstrual-related migraines in a human patient comprising administering a therapeutically effective amount of an anti human calcitonin gene related peptide (CGRP) antibody to the human patient in need thereof; wherein the antibody administered is eptinezumab.
  • CGRP human calcitonin gene related peptide
  • the present disclosure provides a method of treating menstrual-related migraines in a human patient comprising administering a therapeutically effective amount of an anti human calcitonin gene related peptide (CGRP) antibody to the human patient in need thereof; wherein the antibody administered is fremanezumab.
  • CGRP human calcitonin gene related peptide
  • the present disclosure provides a method of treating menstrual-related migraines in a human patient comprising administering a therapeutically effective amount of an anti human calcitonin gene related peptide (CGRP) antibody to the human patient in need thereof; wherein the antibody administered binds to an epitope comprising amino acids VTHRLAGLLSR of SEQ ID NO: 5.
  • CGRP human calcitonin gene related peptide
  • the present disclosure provides a method of treating menstrual-related migraines in a human patient comprising administering a therapeutically effective amount of an anti human calcitonin gene related peptide (CGRP) antibody to the human patient in need thereof; wherein the antibody comprises a heavy chain having a heavy chain variable region having the amino acid sequence of SEQ ID NO: 2 and a light chain having a light chain variable region having the amino acid sequence of SEQ ID NO: 1.
  • CGRP human calcitonin gene related peptide
  • the present disclosure provides a method of treating menstrual-related migraines in a human patient comprising administering a therapeutically effective amount of an anti human calcitonin gene related peptide (CGRP) antibody to the human patient in need thereof; wherein the antibody comprises a heavy chain having the amino acid sequence of SEQ ID NO: 4 and a light chain having the amino acid sequence of SEQ ID NO: 3.
  • CGRP human calcitonin gene related peptide
  • the anti-human CGRP antibody is administered subcutaneously at a dose of about 120 mg to 240 mg; preferably wherein the anti-human CGRP antibody is galcanezumab. In some examples, the anti-human CGRP antibody is administered subcutaneously at a dose of about 120 mg; preferably wherein the anti -human CGRP antibody is galcanezumab. In some examples, the anti-human CGRP antibody is administered subcutaneously at a dose of about 240 mg; preferably wherein the anti human CGRP antibody is galcanezumab.
  • the anti-human CGRP antibody is administered a first dose of about 240 mg and a second dose of 120 mg and wherein the first and second dose are administered about one month apart; preferably wherein the anti-human CGRP antibody is galcanezumab. In some examples, the anti human CGRP antibody is administered once per month; preferably wherein the anti human CGRP antibody is galcanezumab.
  • the present disclosure provides an anti-human calcitonin gene related peptide (CGRP) antibody for use in the treatment of a human patient having menstrual-related migraines.
  • CGRP calcitonin gene related peptide
  • the present disclosure provides an anti-human calcitonin gene related peptide (CGRP) antibody for use in the treatment of a human patient having menstrual-related migraines; wherein the human patient has been diagnosed with episodic migraines prior to receiving the antibody.
  • CGRP calcitonin gene related peptide
  • the present disclosure provides an anti-human calcitonin gene related peptide (CGRP) antibody for use in the treatment of a human patient having menstrual-related migraines; the human patient has been diagnosed with chronic migraines prior to receiving the antibody.
  • CGRP calcitonin gene related peptide
  • the present disclosure provides an anti-human calcitonin gene related peptide (CGRP) antibody for use in the treatment of a human patient having menstrual-related migraines; wherein the human patient experiences auras with their menstrual-related migraines.
  • CGRP calcitonin gene related peptide
  • the present disclosure provides an anti-human calcitonin gene related peptide (CGRP) antibody for use in the treatment of a human patient having menstrual-related migraines; wherein the human patient does not experience auras with their menstrual - related migraines.
  • CGRP calcitonin gene related peptide
  • the present disclosure provides an anti-human calcitonin gene related peptide (CGRP) antibody for use in the treatment of a human patient having menstrual-related migraines; wherein the antibody administered is eptinezumab.
  • CGRP calcitonin gene related peptide
  • the present disclosure provides an anti-human calcitonin gene related peptide (CGRP) antibody for use in the treatment of a human patient having menstrual-related migraines; wherein the antibody administered is fremanezumab.
  • CGRP calcitonin gene related peptide
  • the present disclosure provides an anti-human calcitonin gene related peptide (CGRP) antibody for use in the treatment of a human patient having menstrual-related migraines; wherein the antibody administered binds to an epitope comprising amino acids VTHRLAGLLSR of SEQ ID NO: 5.
  • CGRP calcitonin gene related peptide
  • the present disclosure provides an anti-human calcitonin gene related peptide (CGRP) antibody for use in the treatment of a human patient having menstrual-related migraines; wherein the antibody comprises a heavy chain having a heavy chain variable region having the amino acid sequence of SEQ ID NO: 2 and a light chain having a light chain variable region having the amino acid sequence of SEQ ID NO: 1.
  • CGRP anti-human calcitonin gene related peptide
  • the present disclosure provides an anti-human calcitonin gene related peptide (CGRP) antibody for use in the treatment of a human patient having menstrual-related migraines; wherein the antibody comprises a heavy chain having the amino acid sequence of SEQ ID NO: 4 and a light chain having the amino acid sequence of SEQ ID NO: 3.
  • CGRP anti-human calcitonin gene related peptide
  • the present disclosure provides an anti-human calcitonin gene related peptide (CGRP) antibody for use in the treatment of a human patient having menstrual-related migraines; wherein the antibody is administered subcutaneously at a dose of 120 mg to 240 mg; preferably wherein the anti-human CGRP antibody is galcanezumab.
  • CGRP anti-human calcitonin gene related peptide
  • the present disclosure provides an anti-human calcitonin gene related peptide (CGRP) antibody for use in the treatment of a human patient having menstrual-related migraines; wherein the antibody is administered subcutaneously at a dose of 120 mg; preferably wherein the anti-human CGRP antibody is galcanezumab.
  • the present disclosure provides an anti-human calcitonin gene related peptide (CGRP) antibody for use in the treatment of a human patient having menstrual-related migraines; wherein the antibody is administered subcutaneously at a dose of 240 mg; preferably wherein the anti-human CGRP antibody is galcanezumab.
  • the present disclosure provides an anti-human calcitonin gene related peptide (CGRP) antibody for use in the treatment of a human patient having menstrual-related migraines; wherein the human patient is administered a first dose of 240 mg and a second dose of 120 mg and wherein the first and second dose are administered about one month apart; preferably wherein the anti-human CGRP antibody is galcanezumab.
  • the present disclosure provides an anti-human calcitonin gene related peptide (CGRP) antibody for use in the treatment of a human patient having menstrual-related migraines; wherein the antibody is administered once per month; preferably wherein the anti-human CGRP antibody is galcanezumab.
  • CGRP calcitonin gene related peptide
  • the present disclosure provides a use of an anti-human calcitonin gene related peptide (CGRP) antibody for the manufacture of a medicament for the treatment of menstrual- related migraines.
  • CGRP anti-human calcitonin gene related peptide
  • the present disclosure provides a use of an anti-human calcitonin gene related peptide (CGRP) antibody for the manufacture of a medicament for the treatment of menstrual- related migraines; wherein the human patient has been diagnosed with episodic migraines prior to receiving the antibody.
  • CGRP anti-human calcitonin gene related peptide
  • the present disclosure provides a use of an anti-human calcitonin gene related peptide (CGRP) antibody for the manufacture of a medicament for the treatment of menstrual- related migraines; wherein the human patient has been diagnosed with chronic migraines prior to receiving the antibody.
  • CGRP anti-human calcitonin gene related peptide
  • the present disclosure provides a use of an anti-human calcitonin gene related peptide (CGRP) antibody for the manufacture of a medicament for the treatment of menstrual- related migraines; wherein the human patient experiences auras with their menstrual- related migraines.
  • CGRP anti-human calcitonin gene related peptide
  • the present disclosure provides a use of an anti-human calcitonin gene related peptide (CGRP) antibody for the manufacture of a medicament for the treatment of menstrual- related migraines; wherein the human patient does not experience auras with their menstrual-related migraines.
  • CGRP anti-human calcitonin gene related peptide
  • the present disclosure provides a use of an anti-human calcitonin gene related peptide (CGRP) antibody for the manufacture of a medicament for the treatment of menstrual- related migraines; wherein the antibody administered is eptinezumab.
  • CGRP anti-human calcitonin gene related peptide
  • the present disclosure provides a use of an anti-human calcitonin gene related peptide (CGRP) antibody for the manufacture of a medicament for the treatment of menstrual- related migraines; wherein the antibody administered is fremanezumab.
  • CGRP anti-human calcitonin gene related peptide
  • the present disclosure provides a use of an anti-human calcitonin gene related peptide (CGRP) antibody for the manufacture of a medicament for the treatment of menstrual- related migraines; wherein the antibody administered binds to an epitope comprising amino acids VTHRLAGLLSR of SEQ ID NO: 5.
  • CGRP anti-human calcitonin gene related peptide
  • the present disclosure provides a use of an anti-human calcitonin gene related peptide (CGRP) antibody for the manufacture of a medicament for the treatment of menstrual- related migraines; wherein the antibody comprises a heavy chain having a heavy chain variable region having the amino acid sequence of SEQ ID NO: 2 and a light chain having a light chain variable region having the amino acid sequence of SEQ ID NO: 1.
  • CGRP anti-human calcitonin gene related peptide
  • the present disclosure provides a use of an anti-human calcitonin gene related peptide (CGRP) antibody for the manufacture of a medicament for the treatment of menstrual- related migraines; wherein the antibody comprises a heavy chain having the amino acid sequence of SEQ ID NO: 4 and a light chain having the amino acid sequence of SEQ ID NO: 3.
  • CGRP anti-human calcitonin gene related peptide
  • the present disclosure provides a use of an anti-human calcitonin gene related peptide (CGRP) antibody for the manufacture of a medicament for the treatment of menstrual- related migraines; wherein the antibody is administered subcutaneously at a dose of 120 mg to 240 mg; preferably wherein the anti-human CGRP antibody is galcanezumab.
  • CGRP anti-human calcitonin gene related peptide
  • the present disclosure provides a use of an anti-human calcitonin gene related peptide (CGRP) antibody for the manufacture of a medicament for the treatment of menstrual- related migraines; wherein the antibody is administered subcutaneously at a dose of 120 mg; preferably wherein the anti-human CGRP antibody is galcanezumab.
  • the present disclosure provides a use of an anti-human calcitonin gene related peptide (CGRP) antibody for the manufacture of a medicament for the treatment of menstrual-related migraines; wherein the antibody is administered subcutaneously at a dose of 240 mg; preferably wherein the anti-human CGRP antibody is galcanezumab.
  • the present disclosure provides a use of an anti-human calcitonin gene related peptide (CGRP) antibody for the manufacture of a medicament for the treatment of menstrual-related migraines; wherein the human patient is administered a first dose of 240 mg and a second dose of 120 mg of the antibody and wherein the first and second dose are administered about one month apart; preferably wherein the anti-human CGRP antibody is galcanezumab.
  • CGRP anti-human calcitonin gene related peptide
  • the present disclosure provides a use of an anti-human calcitonin gene related peptide (CGRP) antibody for the manufacture of a medicament for the treatment of menstrual-related migraines; wherein the antibody is administered once per month; preferably wherein the anti-human CGRP antibody is galcanezumab.
  • CGRP anti-human calcitonin gene related peptide
  • the present disclosure provides a pharmaceutical composition comprising an anti human calcitonin gene related peptide (CGRP) antibody for use in the treatment of a human patient having menstrual-related migraines.
  • the present disclosure provides a pharmaceutical composition comprising an anti-human calcitonin gene related peptide (CGRP) antibody for use in the treatment of a human patient having menstrual-related migraines; wherein the antibody comprises a heavy chain having a heavy chain variable region having the amino acid sequence of SEQ ID NO: 2 and a light chain having a light chain variable region having the amino acid sequence of SEQ ID NO: 1.
  • the present disclosure provides a pharmaceutical composition
  • a pharmaceutical composition comprising an anti-human calcitonin gene related peptide (CGRP) antibody for use in the treatment of a human patient having menstrual-related migraines; wherein the antibody comprises a heavy chain having the amino acid sequence of SEQ ID NO: 4 and a light chain having the amino acid sequence of SEQ ID NO: 3.
  • CGRP anti-human calcitonin gene related peptide
  • such embodiments are also further embodiments for use in that treatment, or alternatively for the use of the combination for the manufacture of a medicament for use in that treatment.
  • the perimenstrual period is defined as the day menstruation started, plus the previous and subsequent two days (i.e. a 5-day period around the start of menstruation).
  • a menstrual-related migraine is defined as a migraine headache within the 5-day perimenstrual period.
  • a menstrual-related migraine headache day is defined as a migraine headache day within the 5 -day perimenstrual period.
  • Exploratory analysis included intent-to-treat (ITT) patients who had >0 MRMHD during a one-month baseline period. Using a negative binomial repeated measures model, the estimated number of MRMHD per 30-day period was estimated each month and overall across 6 months for pooled EVOLVE-l & EVOLVE-2 data, and across 3 months for REGAIN.

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Abstract

L'invention concerne des méthodes, des traitements et des utilisations d'anticorps dirigés contre le peptide lié au gène de la calcitonine humaine (CGRP) pour le traitement des migraines liées aux menstruations.
PCT/US2019/033651 2018-05-31 2019-05-23 Anticorps anti-cgrp pour le traitement des migraines liées aux menstruations WO2019231800A1 (fr)

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Citations (3)

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Publication number Priority date Publication date Assignee Title
WO2011156324A1 (fr) 2010-06-10 2011-12-15 Eli Lilly And Company Anticorps anti-cgrp
WO2012162243A2 (fr) * 2011-05-20 2012-11-29 Alderbio Holdings Llc Compositions comprenant des anticorps anti-cgrp et leur utilisation
WO2016205037A1 (fr) * 2015-06-17 2016-12-22 Eli Lilly And Company Formulation d'anticorps anti-cgrp

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011156324A1 (fr) 2010-06-10 2011-12-15 Eli Lilly And Company Anticorps anti-cgrp
WO2012162243A2 (fr) * 2011-05-20 2012-11-29 Alderbio Holdings Llc Compositions comprenant des anticorps anti-cgrp et leur utilisation
WO2016205037A1 (fr) * 2015-06-17 2016-12-22 Eli Lilly And Company Formulation d'anticorps anti-cgrp

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