# US 2025/0154267 A2 · Methods for treating eosinophilic esophagitis by administering an il-4r inhibitor

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- Number: US 2025/0154267 A2
- Document ID: US20250154267A2
- Status: Published application
- Kind: A2
- Application number: 17/327,504
- Filed: 2021-05-21
- Published: 2025-05-15
- Earliest claimed: 2020-05-22
- Assignees: Regeneron Pharmaceuticals, Inc.; Sanofi Biotechnology
- Applicants: Regeneron Pharmaceuticals, Inc.; Sanofi Biotechnology
- Inventors: Jennifer D. HAMILTON; Jennifer MALONEY; Leda MANNENT; Marcella RUDDY
- Web page: https://patentgrep.com/patent/US20250154267A2

## CPC

- A61P 1/04: for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
- C07K 16/2866: {against receptors for cytokines, lymphokines, interferons}
- A61K 31/4439: containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole (nicotine A61K31/465)
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61K 2039/505: {comprising antibodies}
- A61K 2039/545: {characterised by the dose, timing or administration schedule}
- C07K 2317/21: from primates, e.g. man
- C07K 2317/76: Antagonist effect on antigen, e.g. neutralization or inhibition of binding
- 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)
- 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)

## Abstract

The present disclosure provides methods for treating, preventing, or ameliorating one or more symptoms of eosinophilic esophagitis in an adolescent or adult subject by administering to the subject one or more doses of an interleukin-4 receptor (IL-4R) inhibitor, such as an anti-IL-4R antibody or antigen-binding fragment thereof.

## Claims

### Claim 1

A method of treating, preventing, or ameliorating at least one symptom of eosinophilic esophagitis (EoE) in a subject≥12 years of age, the method comprising administering to the subject one or more doses of an interleukin-4 receptor (IL-4R) inhibitor, wherein prior to the onset of treatment the subject has a Dysphagia Symptom Questionnaire (DSQ) score≥10, and wherein the IL-4R inhibitor is an antibody or antigen-binding fragment thereof that binds IL-4Rα and comprises a heavy chain complementarity determining region (HCDR)1 comprising the amino acid sequence of SEQ ID NO:3, an HCDR2 comprising the amino acid sequence of SEQ ID NO:4, an HCDR3 comprising the amino acid sequence of SEQ ID NO:5, a light chain complementarity determining region (LCDR)1 comprising the amino acid sequence of SEQ ID NO:6, an LCDR2 comprising the amino acid sequence of SEQ ID NO:7, and an LCDR3 comprising the amino acid sequence of SEQ ID NO:8.

### Claim 2 (depends on 1)

The method of claim 1, wherein the subject is an adult.

### Claim 3 (depends on 1)

The method of claim 1, wherein the subject is an adolescent≥12 and <18 years of age.

### Claim 4 (depends on 1)

The method of claim 1, wherein prior to the onset of treatment the subject has an intraepithelial eosinophilic infiltration peak cell count≥15 eos/hpf as measured by endoscopic biopsy in at least two of the proximal esophageal region, mid esophageal region, and distal esophageal region.

### Claim 5 (depends on 1)

The method of claim 1, wherein the subject has a concomitant atopic disease.

### Claim 6 (depends on 5)

The method of claim 5, wherein the concomitant atopic disease is a food allergy, atopic dermatitis, asthma, chronic rhinosinusitis, allergic rhinitis, or allergic conjunctivitis.

### Claim 7 (depends on 1)

The method of claim 1, wherein the subject has eosinophilic gastroenteritis.

### Claim 8 (depends on 1)

The method of claim 1, wherein the subject has a history of an average of at least two episodes of dysphagia per week for at least 4 weeks.

### Claim 9 (depends on 1)

The method of claim 1, wherein the subject is unresponsive or inadequately responsive to treatment with a swallowed topical corticosteroid and/or a proton pump inhibitor (PPI).

### Claim 10 (depends on 1)

The method of claim 1, wherein the IL-4R inhibitor comprises a heavy chain variable region (HCVR) comprising the amino acid sequence of SEQ ID NO:1 and a light chain variable region (LCVR) comprising the amino acid sequence of SEQ ID NO:2.

### Claim 11 (depends on 1)

The method of claim 1, wherein the IL-4R inhibitor comprises a heavy chain comprising the amino acid sequence of SEQ ID NO:9 and a light chain comprising the amino acid sequence of SEQ ID NO:10.

### Claim 12 (depends on 1)

The method of claim 1, wherein the IL-4R inhibitor is dupilumab or a bioequivalent thereof.

### Claim 13 (depends on 1)

The method of claim 1, wherein the IL-4R inhibitor is administered at a dose of about 50 mg to about 600 mg.

### Claim 14 (depends on 13)

The method of claim 13, wherein the IL-4R inhibitor is administered at a dose of about 300 mg.

### Claim 15 (depends on 13)

The method of claim 13, wherein the IL-4R inhibitor is administered once a week or once every two weeks.

### Claim 16 (depends on 1)

The method of claim 1, wherein the IL-4R inhibitor is administered in combination with a second therapeutic agent or therapy.

### Claim 17 (depends on 16)

The method of claim 16, wherein the second therapeutic agent or therapy is an IL-1β inhibitor, an IL-5 inhibitor, an IL-9 inhibitor, an IL-13 inhibitor, an IL-17 inhibitor, an IL-25 inhibitor, a TNFα inhibitor, an eotaxin-3 inhibitor, an IgE inhibitor, a prostaglandin D2 inhibitor, an immunosuppressant, a topical corticosteroid, an oral corticosteroid, a systemic corticosteroid, an inhaled corticosteroid, a glucocorticoid, a PPI, a decongestant, an antihistamine, a non-steroidal anti-inflammatory drug (NSAID), esophagus dilation, allergen removal, or diet management.

### Claim 18 (depends on 17)

The method of claim 17, wherein the IL-4R inhibitor is administered in combination with a PPI.

### Claim at position 19

19-27. (canceled)

### Claim 28

A method of improving the ability to swallow food in a subject, the method comprising:
administering to a subject having eosinophilic esophagitis (EoE) one or more doses of an interleukin-4 receptor (IL-4R) inhibitor, wherein the IL-4R inhibitor is an antibody or antigen-binding fragment thereof that binds IL-4Rα and comprises a heavy chain complementarity determining region (HCDR)1 comprising the amino acid sequence of SEQ ID NO:3, an HCDR2 comprising the amino acid sequence of SEQ ID NO:4, an HCDR3 comprising the amino acid sequence of SEQ ID NO:5, a light chain complementarity determining region (LCDR)1 comprising the amino acid sequence of SEQ ID NO:6, an LCDR2 comprising the amino acid sequence of SEQ ID NO:7, and an LCDR3 comprising the amino acid sequence of SEQ ID NO:8.

### Claim 29 (depends on 28)

The method of claim 28, wherein the subject is ≥12 years of age.

### Claim 30 (depends on 29)

The method of claim 29, wherein the subject is an adult.

### Claim 31 (depends on 29)

The method of claim 29, wherein the subject is an adolescent≥12 and <18 years of age.

### Claim 32 (depends on 28)

The method of claim 28, wherein prior to the onset of treatment the subject has a Dysphagia Symptom Questionnaire (DSQ) score≥10.

### Claim 33 (depends on 28)

The method of claim 28, wherein the subject has a concomitant atopic disease.

### Claim 34 (depends on 33)

The method of claim 33, wherein the concomitant atopic disease is a food allergy, atopic dermatitis, asthma, chronic rhinosinusitis, allergic rhinitis, or allergic conjunctivitis.

### Claim 35 (depends on 28)

The method of claim 28, wherein the subject has eosinophilic gastroenteritis.

### Claim 36 (depends on 28)

The method of claim 28, wherein the subject has a history of an average of at least two episodes of dysphagia per week for at least 4 weeks.

### Claim 37 (depends on 28)

The method of claim 28, wherein the subject is unresponsive or inadequately responsive to treatment with a swallowed topical corticosteroid and/or a proton pump inhibitor (PPI).

### Claim 38 (depends on 28)

The method of claim 28, wherein the IL-4R inhibitor comprises a heavy chain variable region (HCVR) comprising the amino acid sequence of SEQ ID NO:1 and a light chain variable region (LCVR) comprising the amino acid sequence of SEQ ID NO:2.

### Claim 39 (depends on 28)

The method of claim 28, wherein the IL-4R inhibitor comprises a heavy chain comprising the amino acid sequence of SEQ ID NO:9 and a light chain comprising the amino acid sequence of SEQ ID NO:10.

### Claim 40 (depends on 28)

The method of claim 28, wherein the IL-4R inhibitor is dupilumab or a bioequivalent thereof.

### Claim 41

The method of 28, wherein the IL-4R inhibitor is administered at a dose of about 50 mg to about 600 mg.

### Claim 42 (depends on 41)

The method of claim 41, wherein the IL-4R inhibitor is administered at a dose of about 300 mg.

### Claim 43 (depends on 41)

The method of claim 41, wherein the IL-4R inhibitor is administered once a week or once every two weeks.

### Claim 44 (depends on 28)

The method of claim 28, wherein the IL-4R inhibitor is administered in combination with a second therapeutic agent or therapy.

### Claim 45 (depends on 44)

The method of claim 44, wherein the second therapeutic agent or therapy is an IL-1β inhibitor, an IL-5 inhibitor, an IL-9 inhibitor, an IL-13 inhibitor, an IL-17 inhibitor, an IL-25 inhibitor, a TNFα inhibitor, an eotaxin-3 inhibitor, an IgE inhibitor, a prostaglandin D2 inhibitor, an immunosuppressant, a topical corticosteroid, an oral corticosteroid, a systemic corticosteroid, an inhaled corticosteroid, a glucocorticoid, a PPI, a decongestant, an antihistamine, a non-steroidal anti-inflammatory drug (NSAID), esophagus dilation, allergen removal, or diet management.

### Claim 46 (depends on 45)

The method of claim 45, wherein the IL-4R inhibitor is administered in combination with a PPI.

### Claim 47

(canceled)

### Claim 48

(canceled)

### Claim 49 (depends on 1)

The method of claim 1, wherein the IL-4R inhibitor is contained within a container selected from the group consisting of a glass vial, a syringe, a pen delivery device, and an autoinjector.

### Claim 50 (depends on 28)

The method of claim 28, wherein the IL-4R inhibitor is contained within a container selected from the group consisting of a glass vial, a syringe, a pen delivery device, and an autoinjector.