# US 10,369,152 B2 · Methods and compositions for the treatment or prevention of abnormal bone formation in a soft tissue

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- Number: US 10,369,152 B2
- Document ID: US10369152B2
- Status: Granted
- Kind: B2
- Application number: 15/550,139
- Filed: 2016-02-12
- Published: 2018-01-25
- Granted: 2019-08-06
- Earliest claimed: 2015-02-13
- Assignees: The Brigham and Women's Hospital, Inc.
- Applicants: The Brigham and Women's Hospital, Inc.
- Inventors: Paul B. Yu; Jana Bagarova; Devaveena Dey
- Web page: https://patentgrep.com/patent/US10369152B2

## CPC

- A61K 31/517: ortho- or peri-condensed with carbocyclic ring systems, e.g. quinazoline, perimidine
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- C07D 401/12: linked by a chain containing hetero atoms as chain links
- C07D 405/14: containing three or more hetero rings
- C07D 487/04: Ortho-condensed systems
- C07D 491/056: with two or more oxygen atoms as ring hetero atoms in the oxygen-containing ring
- A61K 2300/00: Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
- 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)
- C07D: HETEROCYCLIC COMPOUNDS (macromolecular compounds C08)

## Abstract

Provided herein are methods and compositions for the treatment and/or prevention of abnormal bone formation in a soft tissue. In certain embodiments, the methods and compositions treat and/or prevent a disease or disorder comprising abnormal bone formation in soft tissue. Exemplary diseases or disorders that can be treated with the methods and compositions described herein include, but are not limited to, heterotopic ossification diseases such as fibrodysplasia ossificans progressive, anklyosing spondylosis, traumatic heterotopic ossification, burn- or blast-injury associated heterotopic ossification, and joint replacement surgery associated heterotopic ossification.

## Claims

### Claim 1

A method for treating abnormal bone in a soft tissue or preventing additional abnormal bone formation in a soft tissue of a subject, the method comprising: administering a therapeutically effective amount of a pharmaceutical composition comprising AZD0530 or AZD0424 to a subject having abnormal bone formation in a soft tissue, thereby treating or preventing additional formation of abnormal bone in a soft tissue of the subject.

### Claim 2 (depends on 1)

The method of claim 1, further comprising a step of detecting the presence of abnormal bone formation in the subject prior to treatment.

### Claim 3 (depends on 1)

The method of claim 1, wherein the subject has been subjected to a musculoskeletal trauma, a spinal cord injury or a central nervous system injury.

### Claim 4 (depends on 1)

The method of claim 1, wherein the formation of abnormal bone is associated with a heterotopic ossification disease.

### Claim 5 (depends on 4)

The method of claim 4, wherein the heterotopic ossification disease is selected from the group consisting of: acquired heterotopic ossification, fibrodysplasia ossificans progressive, anklyosing spondylosis, traumatic heterotopic ossification, burn- or blast-injury associated heterotopic ossification, and joint replacement surgery associated heterotopic ossification.

### Claim 6 (depends on 1)

The method of claim 1, wherein the therapeutically effective amount of AZD0530 comprises a dose within the range of 5 mg/kg to 250 mg/kg.

### Claim 7 (depends on 1)

The method of claim 1, wherein the therapeutically effective amount of AZD0530 does not cause weight loss greater than 20% of total body mass.

### Claim 8 (depends on 1)

The method of claim 1, wherein the soft tissue comprises muscles, tendons, ligaments and/or fascia.

### Claim 9 (depends on 1)

The method of claim 1, wherein at least one additional agent is administered to the subject.

### Claim 10 (depends on 9)

The method of claim 9, wherein the at least one additional agent comprises a corticosteroid, a non-steroidal anti-inflammatory drug (NSAID), a lipoxygenase inhibitor, a leukotriene inhibitor, a mast cell stabilizing agent, an anti-histamine, a TNF inhibitor, an IL-23 blocker, or an inhibitor of IL-1 signaling.