# US 12,006,359 B2 · Methods for altering body composition by administering anti-pro/latent myostatin antibodies

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- Number: US 12,006,359 B2
- Document ID: US12006359B2
- Status: Granted
- Kind: B2
- Application number: 17/083,917
- Filed: 2020-10-29
- Published: 2021-10-28
- Granted: 2024-06-11
- Earliest claimed: 2016-01-08
- Assignees: Scholar Rock, Inc.
- Applicants: Scholar Rock, Inc.
- Inventors: Adriana Donovan; Michelle Straub; Stefan Wawersik
- Web page: https://patentgrep.com/patent/US12006359B2

## CPC

- C07K 16/22: against growth factors {; against growth regulators}
- A61K 39/3955: {against proteinaceous materials, e.g. enzymes, hormones, lymphokines}
- A61P 3/00: Drugs for disorders of the metabolism (of the blood or the extracellular fluid A61P7/00)
- A61P 21/00: Drugs for disorders of the muscular or neuromuscular system
- A61P 21/04: for myasthenia gravis
- A61P 21/06: Anabolic agents (androgens A61P5/26)
- A61K 2039/505: {comprising antibodies}
- C07K 14/475: Growth factors; Growth regulators
- C07K 2317/21: from primates, e.g. man
- C07K 2317/33: Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
- C07K 2317/51: Complete heavy chain or Fd fragment, i.e. VH + CH1
- C07K 2317/515: Complete light chain, i.e. VL + CL
- C07K 2317/52: Constant or Fc region; Isotype
- C07K 2317/524: CH2 domain
- C07K 2317/565: Complementarity determining region [CDR]
- C07K 2317/622: Single chain antibody (scFv)
- C07K 2317/71: Decreased effector function due to an Fc-modification
- C07K 2317/76: Antagonist effect on antigen, e.g. neutralization or inhibition of binding
- C07K 2317/92: Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
- 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 invention relates to antibodies that specifically bind pro-myostatin and/or latent myostatin, and methods and uses thereof.

## Claims

### Claim 1

A method for improving body composition in a subject in need thereof, the method comprising administering to the subject a pro/latent myostatin inhibitor in an amount effective to alter body composition, wherein the pro/latent myostatin inhibitor is an antibody or antigen-binding fragment thereof comprising:
(a) a heavy chain amino acid sequence that is at least 95% identical to SEQ ID NO: 50 and a light chain amino acid sequence that is at least 95% identical to SEQ ID NO: 51;
(b) a heavy chain variable region sequence that is at least 95% identical to SEQ ID NO: 73 and a light chain variable region sequence that is at least 95% identical to SEQ ID NO: 74; or
(c) a heavy chain variable region sequence that is at least 95% identical to SEQ ID NO: 78 and a light chain variable region sequence that is at least 95% identical to SEQ ID NO: 79.

### Claim 2 (depends on 1)

The method of claim 1, wherein the subject has a spinal cord injury (SCI), obesity, diabetes, diabetes associated with obesity, or Prader-Willi syndrome.

### Claim 3 (depends on 1)

The method of claim 1, wherein the administration decreases a ratio of adipose-to-muscle tissue in the subject.

### Claim 4 (depends on 1)

The method of claim 1, wherein the administration increases energy expenditure in the subject.

### Claim 5 (depends on 1)

The method of claim 1, wherein the antibody or antigen-binding fragment thereof is administered in an amount sufficient to cause an increase in a level of circulating latent myostatin in the subject after the administration as compared to before the administration, wherein the level of circulating latent myostatin is measured in a serum sample from the subject.

### Claim 6 (depends on 1)

The method of claim 1, wherein the antibody or antigen-binding fragment thereof is administered intravenously or subcutaneously.

### Claim 7 (depends on 1)

The method of claim 1, wherein the subject is treated with one or more additional therapies.

### Claim 8 (depends on 1)

The method of claim 1, wherein the antibody or antigen-binding fragment thereof is administered in an amount sufficient to cause two or more of the following in the subject:
(a) an increase in the metabolic rate of the subject;
(b) an increase in insulin sensitivity of the subject;
(c) an increase in a level of brown adipose tissue in the subject;
(d) an increase in a level of beige adipose tissue in the subject;
(e) a decrease in a level of white adipose tissue in the subject;
(f) a decrease in a level of visceral adipose tissue in the subject;
(g) an increase in glucose uptake by a brown adipose tissue, a beige adipose tissue, or a muscle tissue in the subject;
(h) a decrease in glucose uptake by a white adipose tissue or a liver tissue;
(i) an increase in insulin dependent glycemic control in the subject; and/or
(j) prevention of developing a metabolic dysregulation associated with muscle dysfunction in the subject.