# US 10,765,698 B2 · Treatment of disease with poly-N-acetylglucosamine nanofibers

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- Number: US 10,765,698 B2
- Document ID: US10765698B2
- Status: Granted
- Kind: B2
- Application number: 15/457,576
- Filed: 2017-03-13
- Published: 2017-10-26
- Granted: 2020-09-08
- Earliest claimed: 2011-04-15
- Assignees: Marine Polymer Technologies, Inc.
- Applicants: Marine Polymer Technologies, Inc.
- Inventors: John N. Vournakis; Sergio Finkielsztein
- Web page: https://patentgrep.com/patent/US10765698B2

## CPC

- A61K 31/726: Glycosaminoglycans, i.e. mucopolysaccharides (chondroitin sulfate, dermatan sulfate A61K31/737)
- A61F 13/01017: {synthetic, e.g. polymer based}
- A61K 9/0014: {Skin, i.e. galenical aspects of topical compositions (non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00)}
- A61K 9/0024: {Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue (compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L)}
- A61K 9/0092: {Hollow drug-filled fibres, tubes of the core-shell type, coated fibres, coated rods, microtubules or nanotubes}
- A61K 9/02: Suppositories; Bougies; Bases therefor; {Ovules}(apparatus for making A61J3/08; devices for introducing into the body A61M31/00)
- A61K 9/06: Ointments; Bases therefor; {Other semi-solid forms, e.g. creams, sticks, gels (composition of ointments, creams or gels A61K47/00)}
- A61K 9/08: Solutions {(composition of solutions A61K47/00)}
- A61K 9/10: Dispersions; Emulsions
- A61K 9/14: Particulate form, e.g. powders, {Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles (microspheres A61K9/16; microcapsules A61K9/50; nanocapsules, nanoparticles of the matrix type A61K9/51)}
- A61K 47/18: Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61P 17/02: for treating wounds, ulcers, burns, scars, keloids, or the like
- A61P 17/06: Antipsoriatics
- A61K 38/00: Medicinal preparations containing peptides (peptides containing beta-lactam rings A61K31/00; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, A61K31/00; ergot alkaloids of the cyclic peptide type A61K31/48; containing macromolecular compounds having statistically distributed amino acid units A61K31/74; medicinal preparations containing antigens or antibodies A61K39/00; medicinal preparations characterised by the non-active ingredients, e.g. peptides as drug carriers, A61K47/00)
- 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)
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

This application relates to compositions comprising shortened fibers of poly-N-acetylglucosamine and/or a derivative thereof (“sNAG nanofibers”) and the use of such compositions in the treatment of disease.

## Claims

### Claim 1

A method for treating atopic dermatitis in a human subject, comprising topically administering a composition comprising shortened poly-N-acetylglucosamine fibers (“sNAG nanofibers”) to the skin of a human subject in need thereof, wherein the sNAG nanofibers comprise 70%, or more than 70%, of N-acetylglucosamine monosaccharides, wherein more than 50% of the sNAG nanofibers are between 1 to 15 μm in length, and wherein the sNAG nanofibers are the only active ingredient in the composition.

### Claim 2 (depends on 1)

The method of claim 1, wherein the human subject is a human infant, human toddler, or elderly human.

### Claim 3 (depends on 1)

The method of claim 1, wherein the sNAG nanofibers comprise more than 90% of N-acetylglucosamine monosaccharides.

### Claim 4 (depends on 1)

The method of claim 1, wherein the sNAG nanofibers were produced by irradiation of poly-N-acetylglucosamine fibers comprising N-acetylglucosamine monosaccharides, and wherein (i) the poly-N-acetylglucosamine was irradiated in the form of dry fibers at the dose of irradiation of 500-2,000 kgy, or (ii) the poly-N-acetylglucosamine was irradiated in the form of wet fibers at the dose of irradiation of 100-500 kgy.

### Claim 5 (depends on 1)

The method of claim 1, wherein the sNAG nanofibers were produced from a microalgal poly-N-acetylglucosamine.

### Claim 6 (depends on 1)

The method of claim 1, wherein the infrared spectrum (“IR”) of the sNAG nanofibers is about the same as or equivalent to that of non-irradiated microalgal poly-N-acetylglucosamine.

### Claim 7

A method for reducing the severity or duration of one or more symptoms associated with atopic dermatitis in a human subject, comprising topically administering a composition comprising shortened poly-N-acetylglucosamine fibers (“sNAG nanofibers”) to the skin of a human subject in need thereof, wherein the sNAG nanofibers comprise 70%, or more than 70%, of N-acetylglucosamine monosaccharides, wherein more than 50% of the sNAG nanofibers are between 1 to 15 μm in length, and wherein the sNAG nanofibers are the only active ingredient in the composition.

### Claim 8 (depends on 7)

The method of claim 7, wherein the human subject is a human infant, human toddler, or elderly human.

### Claim 9 (depends on 7)

The method of claim 7, wherein one or more of the symptoms associated with atopic dermatitis is dry, itchy, or red skin.

### Claim 10 (depends on 7)

The method of claim 7, wherein the sNAG nanofibers comprise more than 90% of N-acetylglucosamine monosaccharides.

### Claim 11 (depends on 7)

The method of claim 7, wherein the sNAG nanofibers were produced by irradiation of poly-N-acetylglucosamine fibers comprising N-acetylglucosamine monosaccharides, and wherein (i) the poly-N-acetylglucosamine was irradiated in the form of dry fibers at the dose of irradiation of 500-2,000 kgy, or (ii) the poly-N-acetylglucosamine was irradiated in the form of wet fibers at the dose of irradiation of 100-500 kgy.

### Claim 12 (depends on 7)

The method of claim 7, wherein the sNAG nanofibers were produced from a microalgal poly-N-acetylglucosamine.

### Claim 13 (depends on 7)

The method of claim 7, wherein the infrared spectrum (“IR”) of the sNAG nanofibers is about the same as or equivalent to that of non-irradiated microalgal poly-N-acetylglucosamine.

### Claim 14

A method for treating inflammatory bowel disease in a human subject, comprising topically administering a composition comprising shortened poly-N-acetylglucosamine fibers (“sNAG nanofibers”) to a human subject in need thereof, wherein the sNAG nanofibers comprise 70%, or more than 70%, of N-acetylglucosamine monosaccharides, wherein more than 50% of the sNAG nanofibers are between 1 to 15 μm in length, and wherein the sNAG nanofibers are the only active ingredient in the composition.

### Claim 15 (depends on 14)

The method of claim 14, wherein the inflammatory bowel disease is ulcerative colitis.

### Claim 16 (depends on 14)

The method claim 14, wherein the amount of the sNAG nanofibers is effective to achieve one or more of the following: (i) reduce the severity of the inflammatory bowel disease or one or more symptoms thereof, (ii) reduce the duration of the inflammatory bowel disease or one or more symptoms thereof, (iii) reduce the number of symptoms associated with the inflammatory bowel disease.

### Claim 17 (depends on 14)

The method of claim 14, wherein the composition comprising sNAG nanofibers is administered to the anus of the subject or rectally.

### Claim 18 (depends on 14)

The method of claim 14, wherein the sNAG nanofibers comprise more than 90% of N-acetylglucosamine monosaccharides.

### Claim 19 (depends on 14)

The method of claim 14, wherein the sNAG nanofibers were produced by irradiation of poly-N-acetylglucosamine fibers comprising N-acetylglucosamine monosaccharides, and wherein (i) the poly-N-acetylglucosamine was irradiated in the form of dry fibers at the dose of irradiation of 500-2,000 kgy, or (ii) the poly-N-acetylglucosamine was irradiated in the form of wet fibers at the dose of irradiation of 100-500 kgy.

### Claim 20 (depends on 14)

The method of claim 14, wherein the sNAG nanofibers were produced from a microalgal poly-N-acetylglucosamine.

### Claim 21 (depends on 14)

The method of claim 14, wherein the infrared spectrum (“IR”) of the sNAG nanofibers is about the same as or equivalent to that of non-irradiated microalgal poly-N-acetylglucosamine.

### Claim 22 (depends on 1)

The method of claim 1, wherein more than 95% of the sNAG nanofibers are between 1 to 15 μm in length.

### Claim 23 (depends on 7)

The method of claim 7, wherein more than 95% of the sNAG nanofibers are between 1 to 15 μm in length.

### Claim 24 (depends on 14)

The method of claim 14, wherein more than 95% of the sNAG nanofibers are between 1 to 15 μm in length.

### Claim 25 (depends on 1)

The method of claim 1, wherein the average length of the sNAG nanofibers is from about 4 to 7 μm.

### Claim 26 (depends on 7)

The method of claim 7, wherein the average length of the sNAG nanofibers is from about 4 to 7 μm.

### Claim 27 (depends on 14)

The method of claim 14, wherein the average length of the sNAG nanofibers is from about 4 to 7 μm.

### Claim 28 (depends on 1)

The method of claim 1, wherein more than 50% of the sNAG nanofibers are between about 1 to less than 10 μm in length.

### Claim 29 (depends on 7)

The method of claim 7, wherein more than 50% of the sNAG nanofibers are between about 1 to less than 10 μm in length.

### Claim 30 (depends on 14)

The method of claim 14, wherein more than 50% of the sNAG nanofibers are between about 1 to less than 10 μm in length.

### Claim 31 (depends on 1)

The method of claim 1, wherein the length of the fibers is determined by scanning electron microscopic (SEM) analysis.

### Claim 32 (depends on 7)

The method of claim 7, wherein the length of the fibers is determined by scanning electron microscopic (SEM) analysis.

### Claim 33 (depends on 14)

The method of claim 14, wherein the length of the fibers is determined by scanning electron microscopic (SEM) analysis.

### Claim 34 (depends on 1)

The method of claim 1, wherein the poly-N-acetylglucosamine has a (β-1→4 configuration.

### Claim 35 (depends on 7)

The method of claim 7, wherein the poly-N-acetylglucosamine has a (β-1→4 configuration.

### Claim 36 (depends on 14)

The method of claim 14, wherein the poly-N-acetylglucosamine has a (β-1→4 configuration.

### Claim 37 (depends on 14)

The method of claim 14, wherein the inflammatory bowel disease is Crohn's disease.