# US 2020/0399384 A1 · Method of treating diseases using an il-17 receptor antibody formulation

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- Number: US 2020/0399384 A1
- Document ID: US20200399384A1
- Status: Published application
- Kind: A1
- Application number: 17/015,029
- Filed: 2020-09-08
- Published: 2020-12-24
- Earliest claimed: 2010-01-15
- Assignees: Amgen K-A, Inc.
- Applicants: Amgen K-A, Inc.
- Inventors: Dingjiang Liu; Holly Zhuohong Huang; David Andrew Martin; Christopher Boyd Russell; David H. Salinger; Scott Walter Baumgartner; Christopher Endres
- Web page: https://patentgrep.com/patent/US20200399384A1

## CPC

- C07K 16/2866: {against receptors for cytokines, lymphokines, interferons}
- A61K 39/39591: {Stabilisation, fragmentation}
- A61P 1/04: for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
- A61P 1/16: for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
- A61P 3/10: for hyperglycaemia, e.g. antidiabetics
- A61P 5/14: of the thyroid hormones, e.g. T3, T4
- A61P 7/00: Drugs for disorders of the blood or the extracellular fluid
- A61P 7/02: Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
- A61P 7/06: Antianaemics
- A61P 11/00: Drugs for disorders of the respiratory system
- A61P 11/06: Antiasthmatics
- A61P 15/00: Drugs for genital or sexual disorders (for disorders of sex hormones A61P5/24); Contraceptives
- A61P 17/00: Drugs for dermatological disorders
- A61P 17/04: Antipruritics
- A61P 17/06: Antipsoriatics
- A61P 19/00: Drugs for skeletal disorders
- A61P 19/02: for joint disorders, e.g. arthritis, arthrosis
- A61P 21/00: Drugs for disorders of the muscular or neuromuscular system
- A61P 21/04: for myasthenia gravis
- A61P 25/00: Drugs for disorders of the nervous system
- A61P 27/02: Ophthalmic agents
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61P 31/04: Antibacterial agents
- A61P 37/02: Immunomodulators
- A61P 37/06: Immunosuppressants, e.g. drugs for graft rejection
- A61K 2039/505: {comprising 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 2317/565: Complementarity determining region [CDR]
- C07K 2317/76: Antagonist effect on antigen, e.g. neutralization or inhibition of binding
- 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)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

The present disclosure relates to AM-14 pharmaceutical formulations and therapeutic dosing regimens for the treatment of disease.

## Claims

### Claim at position 1

-16. (canceled)

### Claim 17

A method of treating Sjögren's syndrome, dermatomyositis, or
systemic lupus erythematosus in a human patient in need thereof, which method comprises administering to the patient an effective amount of a formulation comprising (i) 30 mM glutamic acid, (ii) a pH of 4.8±0.2, (iii) 3±0.2% proline (w/v), (iv) 0.01±0.002% (w/v) polysorbate 20, and (v) a human monoclonal antibody, or an antigen-binding fragment thereof, wherein the human monoclonal antibody comprises:
(a) a heavy chain CDR1 comprising the amino acid sequence of SEQ ID NO: 5, a heavy chain CDR2 comprising the amino acid sequence of SEQ ID NO: 7, a heavy chain CDR3 comprising the amino acid sequence of SEQ ID NO: 8, and a light chain CDR1 comprising the amino acid sequence of SEQ ID NO: 9, a light chain CDR2 comprising the amino acid sequence of SEQ ID NO: 10, and a light chain CDR3 comprising the amino acid sequence of SEQ ID NO: 11;
(b) a heavy chain variable domain comprising the amino acid sequence of SEQ ID NO: 3 and a light chain variable domain comprising the amino acid sequence of SEQ ID NO: 4; or
(c) a heavy chain variable domain comprising the amino acid sequence of SEQ ID NO: 1 or SEQ ID NO: 12 and a light chain variable domain comprising the amino acid sequence of SEQ ID NO: 2;
wherein the formulation comprises a dose of human monoclonal antibody of about 70 mg, about 140 mg, about 210, or about 280 mg, and whereby the human monoclonal antibody specifically binds to human IL-17 receptor A and inhibits the binding of IL-17A to IL-17 receptor A, and the Sjögren's syndrome, dermatomyositis, or systemic lupus erythematosus is treated in the human patient.

### Claim 18 (depends on 17)

The method of claim 17, wherein the human monoclonal antibody or antigen-binding fragment thereof is selected from a single chain antibody, a diabody, a triabody, a tetrabody, a Fab fragment, a F(ab′)2 fragment, an IgD antibody, an IgE antibody, an IgM antibody, an IgG1 antibody, an IgG2 antibody, an IgG3 antibody; and an IgG4 antibody.

### Claim 19 (depends on 17)

The method of claim 17, wherein the formulation is administered to the patient once a week, once every two weeks, or once every four weeks.

### Claim 20 (depends on 17)

The method of claim 17, wherein the formulation is administered to the patient subcutaneously, intramuscularly, or intravenously.

### Claim 21 (depends on 17)

The method of claim 17, wherein the patient suffers from Sjögren's syndrome.

### Claim 22 (depends on 17)

The method of claim 17, wherein the patient suffers from dermatomyositis.

### Claim 23 (depends on 17)

The method of claim 17, wherein the patient suffers from systemic lupus erythematosus.