Methods of treatment of diseases in which IL-13 activity is detrimental using anti-IL-13 antibodies

Patent metadata

Field	Value
Publication number	US-12129294-B2
Application number	US-202318105316-A
Country	US
Kind code	B2
Filing date	Feb 3, 2023
Priority date	Apr 27, 2016
Publication date	Oct 29, 2024
Grant date	Oct 29, 2024

Abstract

The present invention is directed to methods for treating diseases in which IL-13 activity is detrimental, including eosinophilic esophagitis (EoE) and asthma, by administering to a subject in need of such treatment, a composition containing an interleukin-13 (IL-13) antibody, or an antigen binding fragment, thereof.

First claim

We claim:

1. A method of treating an eosinophilic gastrointestinal disorder in a subject, comprising subcutaneously administering about 180 mg to about 360 mg of an anti-IL-13 antibody, or antigen binding fragment thereof, to the subject weekly, thereby treating eosinophilic gastrointestinal disorder in the subject, wherein the anti-IL-13 antibody, or antigen-binding fragment thereof, comprises six CDRs:
CDR-H1-residues 31-37 of SEQ ID NO:2,
CDR-H2-residues 52-67 of SEQ ID NO:2,
CDR-H3-residues 100-112 of SEQ ID NO:2;
CDR-L1-residues 24-34 of SEQ ID NO:3,
CDR-L2-residues 50-56 of SEQ ID NO:3, and
CDR-L3-residues 89-97 of SEQ ID NO:3;

thereby reducing mean dysphagia symptom composite diary score in the subject by at least 5 points when compared to a subject not treated with the anti-IL-13 antibody, or antigen binding fragment thereof; and
wherein the eosinophilic gastrointestinal disorder is eosinophilic gastritis or eosinophilic gastroenteritis.

2. The method of claim 1 , wherein the anti-IL-13 antibody, or antigen-binding fragment thereof, comprises a heavy chain variable region comprising SEQ ID NO: 2 and a light chain variable region comprising SEQ ID NO: 3.

3. The method of claim 1 , further comprising selecting a subject who exhibits at least one symptom associated with the eosinophilic gastrointestinal disorder.

4. The method of claim 3 , wherein the subject also has a disease or disorder selected from the group consisting of atopic dermatitis, asthma, allergic rhinitis, allergic conjunctivitis, and a combination thereof.

5. The method of claim 1 , wherein the subject is a human subject.

6. The method of claim 1 , wherein the subject is a steroid naive subject who has not previously undergone steroid therapy.

7. The method of claim 1 , wherein the subject has previously undergone steroid therapy.

8. The method of claim 7 , wherein the subject is non-steroid refractory.

9. The method of claim 7 , wherein the subject is steroid-refractory.

10. The method of claim 1 , wherein the anti-IL-13 antibody, or antigen-binding portion thereof, is administered to the subject for at least about 16 weeks.

11. The method of claim 1 , wherein the anti-IL-13 antibody, or antigen-binding portion thereof, is administered to the subject for the duration of the eosinophilic gastrointestinal disorder.

12. The method of claim 1 , further comprising administering an additional agent to the subject.

13. The method of claim 12 , wherein the additional agent is a steroid.

14. The method of claim 13 , wherein the steroid is budesonide.

15. The method of claim 12 wherein the additional agent is selected from the group consisting of: an imaging agent, a cytotoxic agent, an angiogenesis inhibitor, a kinase inhibitor, a co-stimulation molecule blocker, an adhesion molecule blocker, an anti-cytokine antibody or functional fragment thereof; methotrexate, a cyclosporin, a rapamycin, an FK506, a detectable label or reporter, a TNF antagonist, an anti-rheumatic, a muscle relaxant, a narcotic, a non-steroid anti-inflammatory drug (NSAID), an analgesic, an anesthetic, a sedative, a local anesthetic, a neuromuscular blocker, an antimicrobial, an antipsoriatic, a corticosteroid, an anabolic steroid, an erythropoietin, an immunization, an immunoglobulin, an immunosuppressive, a growth hormone, a hormone replacement drug, a radiopharmaceutical, an antidepressant, an antipsychotic, a stimulant, an asthma medication, a beta agonist, an inhaled steroid, an oral steroid, an epinephrine or analog, a cytokine, and a cytokine antagonist.

Assignees

• Abbvie Inc

Inventors

• Timony Gregg
• Gujrathi Sheila
• Peach Robert
• Olson Allan

Classifications

• C07K2317/56

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

• A61K45/06 Primary

  Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca · CPC title

• A61K39/3955 Primary

  against proteinaceous materials, e.g. enzymes, hormones, lymphokines · CPC title

• A61K38/13

  Cyclosporins · CPC title

• A61K31/58

  containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin (digitoxin {A61K31/7048}) · CPC title