# US 2021/0275645 A1 · Compositions and methods for preventing or treating macular degeneration

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- Number: US 2021/0275645 A1
- Document ID: US20210275645A1
- Status: Published application
- Kind: A1
- Application number: 17/173,324
- Filed: 2021-02-11
- Published: 2021-09-09
- Earliest claimed: 2020-02-12
- Assignees: Genofocus Co., Ltd.
- Applicants: GenoFocus, Inc.
- Inventors: Jae G. Pan; Eui J. Kim; Jeong H. Kim; Do Y. Yum
- Web page: https://patentgrep.com/patent/US20210275645A1

## CPC

- A61K 38/446: {Superoxide dismutase (1.15)}
- A23L 29/06: {Enzymes}
- A23L 33/135: Bacteria or derivatives thereof, e.g. probiotics
- A61K 38/179: {for growth factors; for growth regulators}
- A61P 27/02: Ophthalmic agents
- C07K 16/22: against growth factors {; against growth regulators}
- C12Y 115/01001: Superoxide dismutase (1.15.1.1)
- 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)
- A23L: FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF (preservation thereof A23B)
- 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)
- C12Y: ENZYMES

## Abstract

The present invention relates, in part, to methods of preventing or treating macular degeneration in a subject by administering a composition comprising a superoxide dismutase enzyme. The present invention also provides pharmaceutical and/or food compositions comprising a superoxide dismutase enzyme.

## Claims

### Claim 1

A method of treating or preventing macular degeneration, comprising administering to a subject in need thereof a composition comprising a superoxide dismutase (SOD) enzyme; or
a method of decreasing or inhibiting choroidal neovascularization (CNV) by contacting a retina with a composition comprising a SOD enzyme.

### Claim at position 2

-3. (canceled)

### Claim 4 (depends on 1)

The method of claim 1, wherein the SOD enzyme comprises:
(a) the amino acid sequence with at least or about 85% identity to the sequence set forth in SEQ ID NO: 1 or SEQ ID NO: 38;
(b) the amino acid sequence set forth in SEQ ID NO: 1 or SEQ ID NO: 38, wherein the amino acid residue Asn74 and/or Asn137 is deleted or substituted;
(c) the amino acid sequence set forth in SEQ ID NO: 1 or SEQ ID NO: 38, wherein the amino acid residue Asn74 and/or Asn137 is substituted with Asp74 and/or Asp137; or
(d) the amino acid sequence set forth in SEQ ID NO: 1 or SEQ ID NO: 38.

### Claim 5 (depends on 1)

The method of claim 1, wherein the SOD enzyme (i) is an isolated enzyme, (ii) binds manganese, and/or (iii) is coated with shellac.

### Claim 6 (depends on 1)

The method of claim 1, wherein the composition is administered orally, intravenously, intraocularly, or intramuscularly, optionally wherein the composition is administered orally.

### Claim 7

(canceled)

### Claim 8 (depends on 1)

The method of claim 1, wherein the SOD enzyme is from a microorganism, preferably a bacterium, preferably a bacterium generally regarded as safe (GRAS) for use as food, more preferably a Bacillus species bacterium.

### Claim 9 (depends on 8)

The method of claim 8, wherein the SOD enzyme is from Bacillus amyloliquefaciens GF423 strain (KCTC 13222BP).

### Claim 10 (depends on 1)

The method of claim 1, wherein the composition
(i) decreases choroidal neovascularization (CNV);
(ii) decreases cell death in the retina;
(iii) decreases inflammation in the retina;
(iv) decreases the expression of vascular endothelial growth factor (VEGF) in the retina;
(v) decreased the expression of Hypoxia-inducible factor 1-alpha (HIF-1-alpha) in the retina; and/or
(vi) increases the retinal function.

### Claim 11 (depends on 1)

The method of claim 1, wherein the macular degeneration is an age-related macular degeneration (AMD), preferably wherein the AMD is a wet AMD or a neovascular AMD.

### Claim 12 (depends on 1)

The method of claim 1, wherein the composition is a pharmaceutical composition or a nutraceutical food.

### Claim 13 (depends on 1)

The method of claim 1, further comprising administering at least one additional agent that treats macular degeneration; or decreases or inhibits CNV, optionally wherein the at least one additional agent is ranibizumab or aflibercept.

### Claim 14

(canceled)

### Claim 15 (depends on 1)

The method of claim 1, wherein the subject is a mammal, preferably wherein the mammal is a human, a dog, a cat, a mouse, or a rat, optionally wherein the subject is a human.

### Claim at position 15

-26. (canceled)

### Claim 27

An engineered polypeptide, a pharmaceutical composition, or a medical or nutraceutical food comprising a superoxide dismutase (SOD) enzyme.

### Claim at position 17

28-30. (canceled)

### Claim 31 (depends on 27)

The engineered polypeptide, the pharmaceutical composition, or the medical or nutraceutical food of claim 27, wherein the SOD enzyme comprises:
(a) the amino acid sequence with at least or about 85% identity to the sequence set forth in SEQ ID NO: 1 or SEQ ID NO: 38;
(b) the amino acid sequence set forth in SEQ ID NO: 1 or SEQ ID NO: 38, wherein the amino acid residue Asn74 and/or Asn137 is deleted or substituted;
(c) the amino acid sequence set forth in SEQ ID NO: 1 or SEQ ID NO: 38, wherein the amino acid residue Asn74 and/or Asn137 is substituted with Asp74 and/or Asp137; or
(d) the amino acid sequence set forth in SEQ ID NO: 1 or SEQ ID NO: 38.

### Claim 32 (depends on 27)

The engineered polypeptide, the pharmaceutical composition, or the medical or nutraceutical food of claim 27, wherein the SOD enzyme (i) is an isolated enzyme, (ii) binds manganese, and/or (iii) is coated with shellac.

### Claim 33 (depends on 27)

The engineered polypeptide, the pharmaceutical composition, or the medical or nutraceutical food of claim 27, wherein the pharmaceutical composition is an oral composition.

### Claim 34 (depends on 27)

The engineered polypeptide, the pharmaceutical composition, or the medical or nutraceutical food of claim 27, wherein the SOD enzyme is from a microorganism, preferably a bacterium, preferably a bacterium generally regarded as safe (GRAS) for use as food, more preferably a Bacillus species bacterium.

### Claim 35 (depends on 34)

The engineered polypeptide, the pharmaceutical composition, or the medical or nutraceutical food of claim 34, wherein the SOD enzyme is from Bacillus amyloliquefaciens GF423 strain (KCTC 13222BP).

### Claim 36 (depends on 27)

The engineered polypeptide, the pharmaceutical composition, or the medical or nutraceutical food of claim 27, wherein the engineered polypeptide, pharmaceutical composition, or medical or nutraceutical food
(i) decreases choroidal neovascularization (CNV);
(ii) decreases cell death in the retina;
(iii) decreases inflammation in the retina;
(iv) decreases the expression of vascular endothelial growth factor (VEGF) in the retina;
(v) decreased the expression of Hypoxia-inducible factor 1-alpha (HIF-1-alpha) in the retina; and/or
(v) increases the retinal function.

### Claim 37 (depends on 27)

The engineered polypeptide, the pharmaceutical composition, or the medical or nutraceutical food of claim 27, further comprising at least one additional agent that decreases or inhibits CNV in the retina, optionally wherein the at least one additional agent is ranibizumab or aflibercept.

### Claim at position 25

-49. (canceled)

### Claim 50 (depends on 27)

A kit comprising the engineered polypeptide, the pharmaceutical composition, or the medical or nutraceutical food of claim 27.
