# US 11,439,704 B2 · Methods for using anti-myostatin antibodies

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- Number: US 11,439,704 B2
- Document ID: US11439704B2
- Status: Granted
- Kind: B2
- Application number: 16/946,483
- Filed: 2020-06-24
- Published: 2021-02-18
- Granted: 2022-09-13
- Earliest claimed: 2015-09-15
- Assignees: Scholar Rock, Inc.
- Applicants: Scholar Rock, Inc.
- Inventors: Gregory J. Carven; Michelle Straub; Adriana Donovan; Katherine Jane Turner
- Web page: https://patentgrep.com/patent/US11439704B2

## CPC

- 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}
- A61P 21/04: for myasthenia gravis
- A61P 21/06: Anabolic agents (androgens A61P5/26)
- A61K 2039/505: {comprising antibodies}
- A61K 2039/545: {characterised by the dose, timing or administration schedule}
- A61P 9/00: Drugs for disorders of the cardiovascular system
- A61P 21/00: Drugs for disorders of the muscular or neuromuscular system
- C07K 14/475: Growth factors; Growth regulators
- C07K 16/22: against growth factors {; against growth regulators}
- C07K 2317/24: containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
- C07K 2317/33: Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
- C07K 2317/92: Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
- 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)

## Abstract

Aspects of the present disclosure relate to antibodies that specifically bind proMyostatin and/or latent Myostatin and uses thereof.

## Claims

### Claim 1

A method of preventing muscle loss and/or reducing muscle atrophy in a subject, the method comprising administering to a subject in need thereof an effective amount of an antibody that specifically binds pro/latent myostatin, wherein the antibody comprises a heavy chain comprising an amino acid sequence of SEQ ID NO:50 and a light chain comprising an amino acid sequence of SEQ ID NO:51.

### Claim 2 (depends on 1)

The method of claim 1, wherein the muscle loss and/or muscle atrophy is associated with a primary myopathy, a secondary myopathy, amyotrophic lateral sclerosis, spinal muscular atrophy (SMA), androgen deficiency, a disease or condition related to aging, a metabolic myopathy, an acquired myopathy, a congenital myopathy, a muscular dystrophy, disuse atrophy, and/or cachexia.

### Claim 3 (depends on 2)

The method of claim 2, wherein the primary myopathy comprises disuse atrophy; the secondary myopathy comprises denervation, genetic muscle weakness, or cachexia; the disease or condition related to aging comprises sarcopenia, frailty, or androgen deficiency; the metabolic myopathy comprises a glycogen storage disease or a lipid storage disorder; the acquired myopathy comprises external substance-induced myopathy, myositis, myositis ossificans, rhabdomyolysis, myoglobinuria, or disuse atrophy; the congenital myopathy comprises X-linked myotubular myopathy, autosomal dominant centronuclear myopathy, autosomal recessive centronuclear myopathy, nemaline myopathy, or congenital fiber-type disproportion myopathy; the muscular dystrophy comprises Duchenne's muscular dystrophy, Becker's muscular dystrophy, facioscapulohumeral (FSH) muscular dystrophy, or Limb-Girdle muscular dystrophy; the disuse atrophy is associated with trauma, hip fracture, elective joint replacement, critical care myopathy, spinal cord injury, or stroke;
and/or the cachexia is associated with renal failure, acquired immune deficiency syndrome (AIDS), a cardiac condition, cancer, or aging.

### Claim 4 (depends on 1)

The method of claim 1, wherein the muscle loss and/or muscle atrophy is associated with SMA.

### Claim 5 (depends on 1)

The method of claim 1, wherein the muscle loss and/or muscle atrophy is associated with a muscular dystrophy.

### Claim 6 (depends on 5)

The method of claim 5, wherein the muscular dystrophy comprises Duchenne's muscular dystrophy or Becker's muscular dystrophy.

### Claim 7 (depends on 1)

The method of claim 1, wherein the amount is between about 0.3 mg/kg and about 30 mg/kg per dose.

### Claim 8 (depends on 1)

The method of claim 1, wherein the antibody is administered to the subject intravenously or subcutaneously.

### Claim 9

A method of treating a subject having, or at risk of developing, spinal muscular atrophy (SMA), the method comprising administering to the subject an effective amount of an antibody that specifically binds pro/latent myostatin, wherein the antibody comprises a heavy chain comprising an amino acid sequence of SEQ ID NO:50 and a light chain comprising an amino acid sequence of SEQ ID NO:51.

### Claim 10 (depends on 9)

The method of claim 9, wherein the amount is between about 0.3 mg/kg and about 30 mg/kg per dose.

### Claim 11 (depends on 9)

The method of claim 9, wherein the amount is effective to increase muscle mass, enhance force generation, prevent muscle loss, and/or reduce muscle atrophy in the subject.

### Claim 12 (depends on 9)

The method of claim 9, wherein the antibody is administered to the subject intravenously or subcutaneously.