Antagonists of IL-6 to prevent or treat cachexia, weakness, fatigue, and /or fever

• US 10,640,560 B2
• Filed: 05/23/2018
• Issued: 05/05/2020
• Est. Priority Date: 11/25/2008
• Status: Active Grant

• Current Assignee: Vitaeris Inc. (CSL Limited)
• Original Assignee: AlderBio Holdings, LLC (Lundbeck Seattle Biopharmaceuticals, Inc.)
• Inventors: Smith, Jeffrey T. L., Latham, John A., Litton, Mark, Schatzman, Randall
• Primary Examiner(s): Bunner, Bridget E
• Assistant Examiner(s): Hamud, Fozia
• Application Number:
  US15/987,415
• Publication Number:
  US 20190085070A1
• Time in Patent Office: 713 Days
• Field of Search: None
• CPC Class Codes: A61K 2039/505 comprising antibodies
• CPC Class Codes: A61K 2039/545 characterised by the dose, timing or administration schedule
• CPC Class Codes: A61K 39/3955 against proteinaceous materials, e.g. enzymes, hormones, lymphokines
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: C07K 16/248 IL-6
• CPC Class Codes: C07K 2317/34 Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
• CPC Class Codes: C07K 2317/76 Antagonist effect on antigen, e.g. neutralization or inhibition of binding
• CPC Class Codes: C07K 2317/92 Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
• CPC Class Codes: Y02A 50/30 Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

The present invention is directed to therapeutic methods using antibodies and fragments thereof having binding specificity for IL-6 to prevent or treat cachexia, fever, weakness and/or fatigue in a patient in need thereof. In preferred embodiments, the anti-IL-6 antibodies will be humanized and/or will be aglycosylated. Also, in preferred embodiments these patients will comprise those exhibiting (or at risk of developing) an elevated serum C-reactive protein level. In another preferred embodiment, the patient'"'"'s survivability or quality of life will preferably be improved.

Claims

1. A method of treating cardiac-related cachexia, respiratory-related cachexia, renal-related cachexia or age-related cachexia comprising administering to the patient an effective amount of an anti-IL-6 antibody or antibody fragment comprising variable heavy and variable light chain sequences respectively contained in SEQ ID NO:

657 and SEQ ID NO;

709.

2. The method of claim 1, which further comprises detecting cardiac-related cachexia, respiratory-related cachexia, renal-related cachexia or age-related cachexia in the patient before, during or after antibody administration.

3. The method of claim 1, wherein the cachexia comprises respiratory-related cachexia.

4. The method of claim 1, wherein the cachexia comprises renal-related cachexia.

5. The method of claim 1, wherein the cachexia comprises cardiac-related cachexia.

6. The method of claim 1, wherein the cachexia comprises age-related cachexia.

7. The method of claim 1, wherein the anti-IL-6 antibody or antibody fragment comprises human IgG1 constant regions.

8. The method of claim 7, wherein the human IgG1 constant region comprises the light constant chain polypeptide of SEQ ID NO:

586 and heavy constant chain polypeptide of SEQ ID NO;

588.

9. The method of claim 1, wherein the anti-IL-6 antibody or antibody fragment is administered to the patient with a frequency of at most once per period of approximately four weeks.

10. The method of claim 1, wherein the anti-IL-6 antibody or antibody fragment is administered to the patient with a frequency of at most once per period of approximately eight weeks.

11. The method of claim 1, wherein the anti-IL-6 antibody or antibody fragment is administered to the patient with a frequency of at most once per period of approximately twelve weeks.

12. The method of claim 1, wherein the anti-IL-6 antibody or antibody fragment is administered to the patient with a frequency of at most once per period of approximately sixteen weeks.