# US 2025/0154232 A1 · Dosage and administration of anti-c5 antibodies for treatment of myasthenia gravis

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- Number: US 2025/0154232 A1
- Document ID: US20250154232A1
- Status: Published application
- Kind: A1
- Application number: 18/577,912
- Filed: 2022-07-14
- Published: 2025-05-15
- Earliest claimed: 2021-07-14
- Assignees: Alexion Pharmaceuticals, Inc.
- Applicants: Alexion Pharmaceuticals, Inc.
- Inventors: Kenji Fujita; Nishi Rampal; Wei-Jian Pan; Kaushik Patra
- Web page: https://patentgrep.com/patent/US20250154232A1

## CPC

- A61P 21/04: for myasthenia gravis
- C07K 16/18: against material from animals or humans
- A61K 2039/505: {comprising antibodies}
- A61K 2039/545: {characterised by the dose, timing or administration schedule}
- C07K 2317/24: containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
- 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

Provided are methods for clinical treatment of myasthenia gravis (MG) using an anti-C5 antibody or antigen binding fragment thereof.

## Claims

### Claim 1

A method for treating a human patient with Myasthenia Gravis, the method comprising administering an antibody or antigen-binding fragment thereof to the patient, wherein the antibody or an antigen binding fragment thereof comprises CDR1, CDR2, and CDR3 heavy chain sequences as set forth in SEQ ID NOs:19, 18, and 3, respectively, and CDR1, CDR2, and CDR3 light chain sequences as set forth in SEQ ID NOs:4, 5, and 6, respectively, and wherein a treatment effect is observed at week 1 after initiation of treatment.

### Claim 2 (depends on 1)

The method of claim 1, wherein the antibody is ravulizumab.

### Claim 3 (depends on 1)

The method of claim 1, wherein the patient:
(a) is positive for auto-antibodies binding to nicotinic acetylcholine receptor (anti-AChR); and/or
(b) has a Myasthenia Gravis Activities of Daily Living (MG-ADL) score greater than or equal to 6.

### Claim 4

(canceled)

### Claim 5 (depends on 1)

The method of claim 1, wherein the treatment results in the patient experiencing a clinically meaningful improvement (reduction) in the MG-ADL score after 26 weeks.

### Claim 6 (depends on 5)

The method of claim 5, wherein the reduction (i) is at least 3.0 or (ii) is about 4.0.

### Claim 7

(canceled)

### Claim 8 (depends on 1)

The method of claim 1, wherein the treatment results in the patient experiencing a clinically meaningful improvement (reduction) in quantitative Myasthenia Gravis (QMG) score after 26 weeks.

### Claim 9 (depends on 8)

The method of claim 8, wherein the reduction (i) is at least 2.8 or (ii) is about 5.0.

### Claim 10

(canceled)

### Claim 11 (depends on 1)

The method of claim 1, wherein the treatment effect is maintained through week 26 after initiation of treatment or though week 52 after initiation of treatment.

### Claim 12

(canceled)

### Claim 13 (depends on 1)

The method of claim 1, wherein the Myasthenia Gravis is Generalized Myasthenia Gravis.

### Claim 14 (depends on 1)

The method of claim 1, wherein ravulizumab is administered to a patient weighing ≥40 to <60 kg:
(a) once on Day 1 of the administration cycle at a loading dose of 2400 mg; and
(b) on Day 15 of the administration cycle and every eight weeks thereafter at a maintenance dose of 3000 mg.

### Claim 15 (depends on 14)

The method of claim 14, wherein ravulizumab is administered at a dose of 3000 mg every eight weeks after the administration cycle for up to two years.

### Claim 16 (depends on 1)

The method of claim 1, wherein ravulizumab is administered to a patient weighing ≥60 to <100 kg:
(a) once on Day 1 of the administration cycle at a loading dose of 2700 mg; and
(b) on Day 15 of the administration cycle and every eight weeks thereafter at a maintenance dose of 3300 mg.

### Claim 17 (depends on 16)

The method of claim 16, wherein ravulizumab is administered at a dose of 3300 mg every eight weeks after the administration cycle for up to two years.

### Claim 18 (depends on 1)

The method of claim 1, wherein ravulizumab is administered to a patient weighing ≥100 kg:
(a) once on Day 1 of the administration cycle at a loading dose of 3000 mg; and
(b) on Day 15 of the administration cycle and every eight weeks thereafter at a maintenance dose of 3600 mg.

### Claim 19 (depends on 18)

The method of claim 18, wherein ravulizumab is administered at a dose of 3600 mg every eight weeks after the administration cycle for up to two years.

### Claim 20 (depends on 1)

The method of claim 1, wherein
ravulizumab is administered intravenously.

### Claim 21 (depends on 1)

The method of claim 1, wherein the patient has not previously been treated with a complement inhibitor.

### Claim at position 22

22-42. (canceled)

### Claim 43

A method for treating a human patient with Myasthenia Gravis, the method comprising administering ravulizumab to a patient, wherein the patient is positive for auto-antibodies binding to nicotinic acetylcholine receptor (anti-AChR), wherein the patient has a Myasthenia Gravis Activities of Daily Living (MG-ADL) score greater than or equal to 6, wherein the treatment results in the patient experiencing a clinically meaningful improvement (reduction) in the MG-ADL score after 26 weeks, and wherein a treatment effect is observed at week 1 after initiation of treatment.

### Claim 44 (depends on 43)

The method of claim 43, wherein the reduction is at least 3.0.

### Claim 45

A method for treating a human patient with Myasthenia Gravis, the method comprising administering ravulizumab to a patient, wherein the patient is positive for auto-antibodies binding to nicotinic acetylcholine receptor (anti-AChR), wherein the patient has a Myasthenia Gravis Activities of Daily Living (MG-ADL) score greater than or equal to 6, wherein the treatment results in the patient experiencing a clinically meaningful improvement (reduction) in quantitative Myasthenia Gravis (QMG) score after 26 weeks, and wherein a treatment effect is observed at week 1 after initiation of treatment.

### Claim 46 (depends on 45)

The method of claim 45, wherein the reduction is at least 2.8.

### Claim at position 27

47-50. (canceled)

### Claim 51 (depends on 21)

The method of claim 21, wherein the complement inhibitor comprises eculizumab.