# US 10,500,273 B2 · Method of treating a localized fibrotic disorder using an IL-33 antagonist

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- Number: US 10,500,273 B2
- Document ID: US10500273B2
- Status: Granted
- Kind: B2
- Application number: 15/555,027
- Filed: 2016-02-29
- Published: 2018-02-01
- Granted: 2019-12-10
- Earliest claimed: 2015-03-02
- Assignees: 180 Therapeutics LP
- Applicants: Glenn Larsen; Jagdeep Nanchahal; Marc Feldmann
- Inventors: Glenn Larsen; Jagdeep Nanchahal; Marc Feldmann
- Web page: https://patentgrep.com/patent/US10500273B2

## CPC

- A61K 39/395: Antibodies (agglutinins A61K38/36 {; as drug carriers A61K47/50}); Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)}
- A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration}
- A61K 31/00: Medicinal preparations containing organic active ingredients
- A61K 31/713: Double-stranded nucleic acids or oligonucleotides
- A61K 38/193: {Colony stimulating factors [CSF]}
- 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 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- C07K 16/241: {Tumor Necrosis Factors}
- C07K 16/244: {Interleukins [IL]}
- C07K 16/2863: {against receptors for growth factors, growth regulators}
- C07K 16/2878: {against the NGF-receptor/TNF-receptor superfamily, e.g. CD27, CD30, CD40, CD95}
- C12N 15/1136: {against growth factors, growth regulators, cytokines, lymphokines or hormones}
- A61K 9/00: Medicinal preparations characterised by special physical form {(nuclear magnetic resonance contrast preparations or magnetic resonance imaging contrast preparations A61K49/18; preparations containing radioactive substances A61K51/12)}
- A61K 2039/505: {comprising antibodies}
- A61K 2039/507: {Comprising a combination of two or more separate antibodies}
- A61K 2039/54: {characterised by the route of administration}
- A61K 2039/545: {characterised by the dose, timing or administration schedule}
- C07K 2317/21: from primates, e.g. man
- C07K 2317/24: containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
- C07K 2317/31: multispecific
- C07K 2317/52: Constant or Fc region; Isotype
- C07K 2317/55: Fab or Fab'
- C07K 2317/622: Single chain antibody (scFv)
- C07K 2317/76: Antagonist effect on antigen, e.g. neutralization or inhibition of binding
- C07K 2319/30: Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto
- C12N 2310/14: interfering nucleic acids [NA]
- C12N 2310/531: Stem-loop; Hairpin
- C12N 2320/31: Combination therapy
- C12N 2320/35: based on a specific dosage / administration regimen
- 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)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- 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)
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)

## Abstract

The subject invention provides a method of treating a patient suffering from a localized fibrotic condition which comprises administering to the patient an amount of an IL-33 antagonist effective to treat the patient. The subject invention also provides a method of treating a patient suffering from a localized fibrotic condition which comprises administering to the patient an amount of a TNF receptor 2 (TNFR2) antagonist effective to treat the patient.

## Claims

### Claim 1

A method of treating a patient suffering from early disease stage Dupuytren's disease which comprises administering locally at the site of the early disease stage of Dupuytren's disease in the patient, an IL-33 antagonist which is an antibody that specifically binds to, and inhibits activation of, an IL-33 receptor or a binding fragment of such an antibody that specifically binds to and inhibits activation of an IL-33 receptor in an amount effective to downregulate expression of alpha-SMA, ST2 and COL1A1 in the patient's myofibroblasts so as to thereby treat the patient.

### Claim 2 (depends on 1)

The method of claim 1 wherein the IL-33 antagonist is injected to a site of maximal cellularity or maximal inflammation.

### Claim 3 (depends on 1)

The method of claim 1 wherein the effective amount of the IL-33 antagonist is an amount between 0.1 mg and 500 mg.

### Claim 4 (depends on 1)

A method of claim 1, which further comprises co-administering a TNF-α antagonist.

### Claim 5 (depends on 4)

The method of claim 4, wherein the amount of the TNF-α antagonist is between 5 mg and 300 mg.

### Claim 6 (depends on 4)

The method of claim 4, wherein the TNF-α antagonist is one or more of infliximab, adalimumab, certolizumab pegol, golimumab or etanercept.

### Claim 7 (depends on 6)

The method of claim 6, wherein the TNF-α antagonist is golimumab and the amount of golimumab administered is between 1 mg and 90 mg.

### Claim 8 (depends on 6)

The method of claim 6, wherein the TNF-α antagonist is adalimumab and the amount of adalimumab administered is between 5 mg and 100 mg.

### Claim 9 (depends on 6)

The method of claim 6, wherein the TNF-α antagonist is certolizumab pegol and the amount of certolizumab pegol administered is between 50 mg and 200 mg.

### Claim 10 (depends on 6)

The method of claim 6, wherein the TNF-α antagonist is infliximab and the amount of infliximab administered is between 50 mg and 300 mg.

### Claim 11 (depends on 6)

The method of claim 6, wherein the TNF-α antagonist is etanercept and the amount of etanercept administered is between 5 mg and 50 mg.

### Claim 12 (depends on 4)

The method of claim 4, wherein the TNF-α antagonist is a TNF receptor 2 (TNFR2) antagonist.

### Claim 13 (depends on 1)

The method of claim 1, wherein the antibody is a chimeric antibody, a humanized antibody, or a human antibody.