# US 10,441,616 B2 · Pharmaceutical composition for treating or preventing sensorineural hearing loss, containing cysteinyl leukotriene receptor antagonist and ginkgo leaf extract

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- Number: US 10,441,616 B2
- Document ID: US10441616B2
- Status: Granted
- Kind: B2
- Application number: 15/120,580
- Filed: 2015-02-23
- Published: 2017-06-15
- Granted: 2019-10-15
- Earliest claimed: 2014-02-20
- Assignees: Ajou University Industry-Academic Cooperation Foundation
- Applicants: Ajou University Industry-Academic Cooperation Foundation
- Inventors: Sang Myun Park; Jung Sub Park; Yun Hoon Choung; Yeon Ju Kim
- Web page: https://patentgrep.com/patent/US10441616B2

## CPC

- A61K 36/16: Ginkgophyta, e.g. Ginkgoaceae (Ginkgo family)
- A61K 31/47: Quinolines; Isoquinolines
- A61K 31/573: substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
- A61P 27/16: Otologicals
- A61K 2121/00: Preparations for use in therapy
- 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)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

The present invention provides a compound having an effect of preventing and/or treating the damage or degeneration of cochlear (and vestibular) mother cells and spiral ganglion neurons by downregulating a cysteinyl leukotriene receptor. Particularly, the present invention provides a composition for preventing or treating sensorineural hearing loss, containing a cysteinyl leukotriene receptor and a Ginkgo biloba extract as active ingredients, on the basis of the co-administration of a cysteinyl leukotriene receptor and a Ginkgo biloba extract having an excellent effect of protecting hearing.

## Claims

### Claim 1

A method of treating sensorineural hearing loss caused by damage to hair cells in an inner ear and surrounding tissue thereof, comprising administering to a subject in need thereof a therapeutically effective amount of a pharmaceutical composition comprising a compound of Chemical Formula 1:
the pharmaceutical composition treating sensorineural hearing loss caused by damage to hair cells in an inner ear and surrounding tissue thereof in the subject.

### Claim 2 (depends on 1)

The method of claim 1, wherein the sensorineural hearing loss is noise-induced hearing loss or presbycusis (age related).

### Claim 3 (depends on 1)

The method of claim 1, wherein the pharmaceutical composition is administered orally.

### Claim 4 (depends on 1)

The method of claim 1, wherein the pharmaceutical composition is co-administrated with at least one drug selected from prednisolone and methylprednisolone.

### Claim 5 (depends on 1)

The method of claim 1, wherein the pharmaceutical composition is administered in amount of 0.8-10 mg/kg per day so as to downregulate a cysteinyl leukotriene receptor.

### Claim 6

A method of improving sensorineural hearing loss caused by damage to hair cells in an inner ear and surrounding tissue thereof, comprising administering to a subject in need thereof an effective amount of a food composition comprising a compound of Chemical Formula 1:
the food composition improving sensorineural hearing loss caused by damage to hair cells in an inner ear and surrounding tissue thereof in the subject.

### Claim 7

A method of treating sensorineural hearing loss caused by damage to hair cells in an inner ear and surrounding tissue thereof, comprising administering to a subject in need thereof a therapeutically effective amount of a pharmaceutical composition comprising (a) a compound of Chemical Formula 1, and (b) a Ginkgo biloba extract:
the pharmaceutical composition treating sensorineural hearing loss caused by damage to hair cells in an inner ear and surrounding tissue thereof in the subject.

### Claim 8 (depends on 7)

The method of claim 7, wherein the sensorineural hearing loss is noise-induced hearing loss or presbycusis cage related).

### Claim 9 (depends on 7)

The method of claim 7, wherein the compound of Chemical Formula 1 is an antagonist of and downregulates a cysteinyl leukotriene receptor.

### Claim 10 (depends on 9)

The method of claim 9, wherein the cysteinyl leukotriene receptor is a cysteinyl leukotriene Type 1 receptor (CysLT1).

### Claim 11 (depends on 7)

The method of claim 7, further comprising the pharmaceutical composition protecting the hair cells.

### Claim 12 (depends on 7)

The method of claim 7, wherein the pharmaceutical composition is administrated orally.

### Claim 13 (depends on 12)

The method of claim 12, wherein the pharmaceutical composition is administrated in a formulation selected from solid pharmaceutical preparations and oral liquid pharmaceutical preparations.

### Claim 14 (depends on 13)

The method of claim 13, wherein the solid pharmaceutical preparations are selected from tablets, pills, capsules, powders, and granules.

### Claim 15 (depends on 13)

The method of claim 13, wherein the oral liquid pharmaceutical preparations are selected from pharmaceutically acceptable aqueous solutions, suspensions, emulsions, syrups, pharmaceutical preparations which are dissolved in use, and elixirs.

### Claim 16 (depends on 7)

The method of claim 7, wherein the compound of Chemical Formula 1 reduces the expression of a matrix metalloproteinase-3 (Mmp3) gene.

### Claim 17 (depends on 7)

The method of claim 7, wherein the compound of Chemical Formula 1 reduces the level of zinc-dependent endopeptidase.

### Claim 18 (depends on 7)

The method of claim 7, wherein the pharmaceutical composition is co-administrated with at least one drug selected from prednisolone and methylprednisolone.

### Claim 19 (depends on 7)

The method of claim 7, wherein the pharmaceutical composition is administered in amount of 0.8-10 mg/kg per day so as to downregulate a cysteinyl leukotriene receptor.

### Claim 20

A method of improving sensorineural hearing loss caused by damage to hair cells in an inner ear and surrounding tissue thereof, comprising administering to a subject in need thereof an effective amount of a food composition comprising (a) a compound of Chemical Formula 1, and (b) a Ginkgo biloba extract:
the food composition improving sensorineural hearing loss caused by damage to hair cells in an inner ear and surrounding tissue thereof in the subject.
