# US 12,600,772 B2 · Therapeutic agent for asthma containing IL-6 inhibitor

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- Number: US 12,600,772 B2
- Document ID: US12600772B2
- Status: Granted
- Kind: B2
- Application number: 16/963,311
- Filed: 2019-01-31
- Published: 2021-11-25
- Granted: 2026-04-14
- Earliest claimed: 2018-01-31
- Assignees: Motokazu Kato
- Applicants: Motokazu Kato
- Inventors: Motokazu Kato
- Web page: https://patentgrep.com/patent/US12600772B2

## CPC

- A61K 31/137: Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine {or methadone}
- C07K 16/248: {IL-6}
- A61K 31/58: containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin (digitoxin {A61K31/7048})
- A61K 39/395: Antibodies (agglutinins A61K38/36 {; as drug carriers A61K47/50}); Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61K 39/3955: {against proteinaceous materials, e.g. enzymes, hormones, lymphokines}
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61P 11/00: Drugs for disorders of the respiratory system
- A61P 11/06: Antiasthmatics
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- C07K 16/2866: {against receptors for cytokines, lymphokines, interferons}
- A61K 2039/545: {characterised by the dose, timing or administration schedule}
- C07K 2317/76: Antagonist effect on antigen, e.g. neutralization or inhibition of binding
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

The present invention provides therapeutic agents for treating human asthma through administration of an IL-6 inhibitor to humans. Representative IL-6 inhibitors in the present invention include IL-6 receptor antibodies and IL-6 antibodies. Therapeutic agents of the present invention can yield therapeutic effects in severe asthma patients who need administration of high-dose steroids and such for alleviation of symptoms, or even in patients whose symptoms are difficult to control by common treatment.

## Claims

### Claim 1

A method for treating human severe non-eosinophilic asthma, comprising administering 162 mg of an anti-IL-6 receptor antibody to a human adult subject in need thereof, wherein the anti-IL-6 receptor antibody is tocilizumab.

### Claim 2 (depends on 1)

The method of claim 1, wherein tocilizumab comprises:
a) the heavy chain variable region of SEQ ID NO: 1 and the light chain variable region of SEQ ID NO: 2; or
b) the heavy chain variable region of SEQ ID NO: 5 and the light chain variable region of SEQ ID NO: 6.

### Claim 3 (depends on 1)

The method of claim 1, wherein tocilizumab comprises:
a) the heavy chain of SEQ ID NO: 3 and the light chain of SEQ ID NO: 4, or
b) the heavy chain of SEQ ID NO: 7 and the light chain of SEQ ID NO: 8.

### Claim 4 (depends on 1)

The method of claim 1, wherein the blood C-reactive protein (CRP) of the subject administered the anti-IL-6 receptor antibody is above normal level.

### Claim 5 (depends on 1)

The method of claim 1, wherein the subject has rheumatoid arthritis.

### Claim 6 (depends on 1)

The method of claim 1, wherein the administration results in:
suppression of at least one asthmatic symptom in the subject selected from coughing, wheezing, expectoration, and dyspnea;
a) improvement of respiratory function of the subject as measured by Peak Expiratory Flow (PEF); or
b) reduction in the amount of steroid use by the subject.

### Claim 7 (depends on 1)

The method of claim 1, wherein the administration results in an improved Asthma Control Test (ACT) score in the subject and wherein the improved ACT score is 20 or greater.

### Claim 8 (depends on 1)

The method of claim 1, wherein the anti-IL-6 receptor antibody is administered in combination with an inhaled steroid or a systemic steroid.

### Claim 9 (depends on 1)

The method of claim 1, wherein the anti-IL-6 receptor antibody is administered in combination with an additional long-acting β2-agonist.