Anti-CGRP compositions and use thereof

Patent metadata

Field	Value
Publication number	US-10179809-B2
Application number	US-201815892804-A
Country	US
Kind code	B2
Filing date	Feb 9, 2018
Priority date	May 20, 2011
Publication date	Jan 15, 2019
Grant date	Jan 15, 2019

Abstract

The present invention is directed to antibodies and fragments thereof having binding specificity for CGRP. Another embodiment of this invention relates to the antibodies described herein, and binding fragments thereof, comprising the sequences of the VH, VL and CDR polypeptides described herein, and the polynucleotides encoding them. The invention also contemplates conjugates of anti-CGRP antibodies and binding fragments thereof conjugated to one or more functional or detectable moieties. The invention also contemplates methods of making said anti-CGRP antibodies and binding fragments thereof. Embodiments of the invention also pertain to the use of anti-CGRP antibodies, and binding fragments thereof, for the diagnosis, assessment and treatment of diseases and disorders associated with CGRP.

First claim

What is claimed is:

1. A method of treating, preventing, ameliorating, or reducing migraine or a symptom of migraine in a patient in need thereof comprising administering to said patient a therapeutically effective amount of a pharmaceutical composition comprising a humanized anti-calcitonin gene related peptide (CGRP) antibody comprising a variable light (V L ) chain polypeptide comprising the complementarity-determining region (CDR) polypeptides CDR1, CDR2, and CDR3, respectively, of SEQ ID NO: 55, SEQ ID NO: 56 and SEQ ID NO: 57 and a variable heavy (V H ) chain polypeptide comprising the CDR polypeptides CDR1, CDR2, and CDR3, respectively, of SEQ ID NO: 58, SEQ ID NO: 59 and SEQ ID NO: 60.

2. The method of claim 1 , wherein the humanized anti-CGRP antibody comprises a V L chain polypeptide possessing at least 90% sequence identity to SEQ ID NO: 51 and a V H chain polypeptide possessing at least 90% sequence identity to SEQ ID NO: 53.

3. The method of claim 2 , wherein said pharmaceutical composition is administered acutely or prophylactically.

4. The method of claim 1 , wherein the humanized anti-CGRP antibody comprises a V L chain polypeptide of SEQ ID NO: 51 and a V H chain polypeptide of SEQ ID NO: 53.

5. The method of claim 4 , wherein said pharmaceutical composition is administered acutely or prophylactically.

6. The method of claim 4 , wherein the pharmaceutical composition comprises an aqueous solution and is administered intravenously once every sixteen to once every eight weeks.

7. The method of claim 1 , wherein the humanized anti-CGRP antibody comprises a light chain polypeptide of SEQ ID NO: 52 and a heavy chain polypeptide of SEQ ID NO: 54.

8. The method of claim 7 , wherein said pharmaceutical composition is administered acutely or prophylactically.

9. The method of claim 7 , wherein the pharmaceutical composition comprises an aqueous solution and is administered intravenously once every sixteen to once every eight weeks.

10. The method of claim 1 , wherein said pharmaceutical composition is administered acutely or prophylactically.

11. The method of claim 1 , wherein the pharmaceutical composition comprises an aqueous solution and is administered intravenously once every sixteen to once every eight weeks.

12. A method of treating, preventing, ameliorating, or reducing migraine or a symptom of migraine in a patient in need thereof by administering to said patient a therapeutically or prophylactically effective amount of a pharmaceutical composition comprising a humanized anti-calcitonin gene related peptide (CGRP) antibody selected from the group consisting of:
a. a variable light (V L ) chain polypeptide comprising the complementarity-determining region (CDR) polypeptides CDR1, CDR2, and CDR3, respectively, of SEQ ID NO: 55, SEQ ID NO: 56 and SEQ ID NO: 57 and a variable heavy (V H ) chain polypeptide comprising the CDRs polypeptides CDR1, CDR2, and CDR3, respectively, of SEQ ID NO: 58, SEQ ID NO: 59 and SEQ ID NO: 60;
b. a V L chain polypeptide of SEQ ID NO: 51 and a V H chain polypeptide of SEQ ID NO: 53; and
c. a light chain polypeptide of SEQ ID NO: 52 and a heavy chain polypeptide of SEQ ID NO: 54.

13. The method of claim 12 , wherein the treatment is acute.

14. The method of claim 12 , wherein the treatment is prophylactic.

15. The method of claim 12 , wherein the composition is administered intravenously.

16. The method of claim 12 , wherein the composition is administered subcutaneously.

17. The method of claim 12 , wherein the administered composition comprises an aqueous solution.

18. The method of claim 12 , wherein the composition is administered once every twenty-six to once every sixteen weeks.

19. The method of claim 12 , wherein the composition is administered once every sixteen to once every eight weeks.

20. The method of claim 12 , wherein the composition is administered once every eight to once every four weeks.

21. The method of claim 12 , wherein the composition is administered once every four to once every two weeks.

22. The method of claim 12 , wherein the composition is administered with another anti-CGRP antibody or therapeutic agent.

23. The method of claim 12 , where the administration of the other antibody or agent is simultaneous, concurrent or staggered.

24. The method of claim 12 , wherein the migraine comprises chronic migraine.

25. The method of claim 12 , wherein the migraine comprises frequent episodic migraine.

26. The method of claim 12 , wherein the migraine comprises menstrual migraine.

27. The method of claim 12 , wherein the migraine is a hemiplegic migraine.

28. The method of claim 12 , wherein the migraine comprises allergy-induced migraine.

29. The method of claim 12 , wherein the migraine is with an aura.

30. A method of treatment comprising treating, preventing, ameliorating, or reducing chronic migraine or frequent episodic migraine or symptoms of chronic migraine or frequent episodic migraine by administering to a patient in need thereof a therapeutically effective amount of a pharmaceutical composition, wherein said composition is an aqueous solution comprising a humanized anti-calcitonin gene related peptide (CGRP) antibody selected from the group consisting of:
a. a variable light (V L ) chain polypeptide comprising the complementarity-determining region (CDR) polypeptides CDR1, CDR2, and CDR3, respectively, of SEQ ID NO: 55, SEQ ID NO: 56 and SEQ ID NO: 57, and a variable heavy (V H ) chain polypeptide comprising the CDR polypeptides CDR1, CDR2, and CDR3, respectively, of SEQ ID NO: 58, SEQ ID NO: 59 and SEQ ID NO: 60;
b. a V L chain polypeptide of SEQ ID NO: 51 and a V H chain polypeptide of SEQ ID NO: 53; and
c. a light chain polypeptide of SEQ ID NO: 52 and a heavy chain polypeptide of SEQ ID NO: 54;

wherein said composition is administered to the patient once every sixteen to once every eight weeks.

Assignees

• Alderbio Holdings Llc

Inventors

• Kovacevich Brian Robert
• Garcia-Martinez Leon F
• Anderson Katie Olson
• Dutzar Benjamin H
• Billgren Jens J
• Latham John A
• Mitchell Danielle M
• Mcneill Patricia Dianne
• Janson Nicole M
• Loomis Maria-Cristina

Classifications

• A61P25/00

  Drugs for disorders of the nervous system · CPC title

• C07K2317/24

  containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered · CPC title

• C07K2317/52

  Constant or Fc region; Isotype · CPC title

• C07K2317/565

  Complementarity determining region [CDR] · CPC title

• C07K2317/56

  variable (Fv) region, i.e. VH and/or VL · CPC title