# US 2019/0167695 A1 · Compositions and methods for preventing or treating muscle conditions

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- Number: US 2019/0167695 A1
- Document ID: US20190167695A1
- Status: Published application
- Kind: A1
- Application number: 16/148,976
- Filed: 2018-10-01
- Published: 2019-06-06
- Earliest claimed: 2017-06-09
- Assignees: The Board of Trustees of the Leland Stanford Junior University
- Applicants: The Board of Trustees of the Leland Stanford Junior University
- Inventors: Helen M. Blau; Adelaida R. Palla; Andrew Tri Van Ho
- Web page: https://patentgrep.com/patent/US20190167695A1

## CPC

- A61K 31/5575: having a cyclopentane, e.g. prostaglandin E2, prostaglandin F2-alpha
- A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)}
- A61K 31/167: having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
- A61K 31/245: Amino benzoic acid types, e.g. procaine, novocaine (salicylic acid esters A61K31/60)
- A61K 31/445: Non condensed piperidines, e.g. piperocaine
- A61K 31/46: 8-Azabicyclo [3.2.1] octane; Derivatives thereof, e.g. atropine, cocaine
- A61K 31/47: Quinolines; Isoquinolines
- A61K 33/00: Medicinal preparations containing inorganic active ingredients
- A61K 33/06: Aluminium, calcium or magnesium; Compounds thereof {, e.g. clay}
- A61K 33/24: Heavy metals; Compounds thereof
- A61K 33/32: Manganese; Compounds thereof
- A61K 35/583: Snakes; Lizards, e.g. chameleons (therapeutic use of a snake venom protein A61K38/00)
- A61K 35/64: Insects, e.g. bees, wasps or fleas
- A61K 38/1703: {from vertebrates}
- A61K 38/465: {acting on ester bonds (3.1), e.g. lipases, ribonucleases}
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61P 21/00: Drugs for disorders of the muscular or neuromuscular system
- A61P 21/06: Anabolic agents (androgens A61P5/26)
- 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

Provided herein are compositions for preventing or treating muscle conditions such as muscle damage, injury, or atrophy. In some embodiments, the compositions comprise a prostaglandin E2 (PGE2) compound and a myotoxin. In some embodiments, the muscle damage, injury, or atrophy is the result of a nerve injury, a surgical procedure, or a traumatic injury. Methods of promoting muscle regeneration and methods of increasing muscle mass are also provided herein.

## Claims

### Claim 1

A method of treating a muscle condition, the method comprising:
(a) administering a prostaglandin E2 (PGE2) compound to a subject in need thereof and
(b) administering a myotoxin to the subject,
wherein the administering is by intramuscular administration.

### Claim 2 (depends on 1)

The method of claim 1, wherein the PGE2 compound is selected from the group consisting of PGE2, a PGE2 derivative, a PGE2 prodrug, a PGE2 receptor agonist, a compound that attenuates PGE2 catabolism, a compound that neutralizes PGE2 inhibition, a derivative thereof, an analog thereof, and a combination thereof.

### Claim 3 (depends on 2)

The method of claim 2, wherein the PGE2 compound is PGE2.

### Claim 4 (depends on 2)

The method of claim 2, wherein the PGE2 compound is a PGE2 derivative, and the PGE2 derivative comprises 16,16-dimethyl prostaglandin E2.

### Claim 5 (depends on 2)

The method of claim 2, wherein the PGE2 compound is a compound that attenuates PGE2 catabolism, and the compound that attenuates PGE2 catabolism comprises a compound, neutralizing peptide, or neutralizing antibody that inactivates or blocks 15-hydroxyprostaglandin dehydrogenase (15-PGDH) or inactivates or blocks a prostaglandin transporter (PGT or SLCO2A1).

### Claim 6 (depends on 1)

The method of claim 1, wherein the myotoxin is selected from the group consisting of an anesthetic, a divalent cation, snake venom, lizard venom, bee venom, and a combination thereof.

### Claim 7 (depends on 6)

The method of claim 6, wherein the myotoxin is an anesthetic, and the anesthetic is selected from the group consisting of an amino-amide anesthetic, an amino-ester anesthetic, and a combination thereof.

### Claim 8 (depends on 6)

The method of claim 6, wherein the anesthetic is an amino-amide anesthetic, and the amino-amide anesthetic is selected from the group consisting of bupivacaine, levobupivacaine, articaine, ropivacaine, butanilicaine, carticaine, dibucaine, etidocaine, lidocaine, mepivacaine, prilocaine, trimecaine, and a combination thereof.

### Claim 9 (depends on 6)

The method of claim 6, wherein the anesthetic is an amino-ester anesthetic, and the amino-ester anesthetic is selected from the group consisting of an aminobenzoic acid ester anesthetic, a benzoic acid ester anesthetic, and a combination thereof.

### Claim 10 (depends on 9)

The method of claim 9, wherein the amino-ester anesthetic is an aminobenzoic acid ester anesthetic, and the aminobenzoic acid ester anesthetic is selected from the group consisting of benzocaine, butacaine, butamben, chloroprocaine, dimethocaine, lucaine, meprylcaine, metabutethamine, metabutoxycaine, nitracaine, orthocaine, propoxycaine, procaine, proxymetacaine, risocaine, tetracaine, and a combination thereof.

### Claim 11 (depends on 9)

The method of claim 9, wherein the amino-ester anesthetic is a benzoic acid ester anesthetic, and the benzoic acid ester anesthetic is selected from the group consisting of amylocaine, cocaine, cyclomethycaine, α-eucaine, β-eucaine, hexylcaine, isobucaine, piperocaine, and a combination thereof.

### Claim 12 (depends on 6)

The method of claim 6, wherein the myotoxin is a snake venom or a lizard venom, and the snake venom or the lizard venom is selected from the group consisting of notexin, cardiotoxin, bungarotoxin, and a combination thereof.

### Claim 13 (depends on 6)

The method of claim 6, wherein the myotoxin is a divalent cation, and the divalent cation is selected from the group consisting of Ba2+, Sr2+, Mg2+, Ca2+, Mn2+, Ni2+, Co2+, a salt thereof, and a combination thereof.

### Claim 14 (depends on 1)

The method of claim 1, wherein the PGE2 compound is PGE2 and/or 16,16-dimethyl prostaglandin E2, and the myotoxin is bupivacaine.

### Claim 15 (depends on 1)

The method of claim 1, wherein the muscle condition comprises muscle damage, injury, or atrophy.

### Claim 16 (depends on 1)

The method of claim 1, wherein the intramuscular administration comprises an intramuscular injection into a skeletal muscle.

### Claim 17 (depends on 1)

The method of claim 1, wherein intramuscular administration comprises an acute exposure, an intermittent exposure, a chronic exposure, or a continuous exposure, to the subject.

### Claim 18 (depends on 1)

The method of claim 1, wherein the intramuscular administration comprises an intramuscular injection into a muscle that is injured, damaged or atrophied.

### Claim 19 (depends on 1)

The method of claim 1, wherein the method comprises administering the prostaglandin E2 (PGE2) compound and administering the myotoxin together in a single formulation to the subject.

### Claim 20 (depends on 1)

The method of claim 1, wherein the method comprises administering the prostaglandin E2 (PGE2) compound and administering the myotoxin sequentially in separate formulations to the subject.

### Claim 21 (depends on 20)

The method of claim 20, wherein the method comprises administering the prostaglandin E2 (PGE2) compound before administering the myotoxin to the subject.

### Claim 22 (depends on 20)

The method of claim 20, wherein the method comprises administering the prostaglandin E2 (PGE2) compound after administering the myotoxin to the subject.

### Claim 23 (depends on 1)

The method of claim 1, the method comprising administering the prostaglandin E2 (PGE2) compound with a pharmaceutically suitable excipient and administering the myotoxin with a pharmaceutically suitable excipient to the subject in need thereof by intramuscular administration.

### Claim 24 (depends on 1)

The method of claim 1, the method comprising administering the prostaglandin E2 (PGE2) compound and the myotoxin with the pharmaceutically suitable excipient in a single formulation to the subject in need thereof by intramuscular administration.

### Claim 25 (depends on 1)

The method of claim 1, the method comprising administering the prostaglandin E2 (PGE2) compound with a pharmaceutically suitable excipient and administering the myotoxin with a pharmaceutically suitable excipient sequentially in separate formulations to the subject in need thereof by intramuscular administration.

### Claim 26 (depends on 1)

The method of claim 1, wherein the intramuscular administration comprises an intramuscular injection into the muscle with the muscle condition.