# US 11,433,112 B1 · Collagen peptide-based medicament compositions and devices and methods of production and use thereof

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- Number: US 11,433,112 B1
- Document ID: US11433112B1
- Status: Granted
- Kind: B1
- Application number: 17/749,729
- Filed: 2022-05-20
- Published: 2022-09-08
- Granted: 2022-09-06
- Earliest claimed: 2017-04-06
- Assignees: Sustain Holdings, LLC
- Applicants: Sustain Holdings, LLC
- Inventors: Richard Eric Schlumpf; Robert Baratta; Shawn A. Delorey
- Web page: https://patentgrep.com/patent/US11433112B1

## CPC

- A61K 38/014: {from connective tissue peptides, e.g. gelatin, collagen}
- 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 38/39: Connective tissue peptides, e.g. collagen, elastin, laminin, fibronectin, vitronectin, cold insoluble globulin [CIG]
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61L 17/005: {containing a biologically active substance, e.g. a medicament or a biocide}
- A61L 17/08: of animal origin, e.g. catgut, collagen
- A61L 27/10: Ceramics or glasses
- A61L 27/24: Collagen
- A61L 27/54: Biologically active materials, e.g. therapeutic substances {(A61L27/227 takes precedence)}
- A61L 29/045: {Collagen}
- A61L 29/085: {Macromolecular materials}
- A61L 29/16: Biologically active materials, e.g. therapeutic substances {(A61L29/048 takes precedence)}
- A61L 31/044: {Collagen}
- A61L 31/10: Macromolecular materials
- A61L 31/16: Biologically active materials, e.g. therapeutic substances {(A61L31/047 takes precedence)}
- A61P 19/02: for joint disorders, e.g. arthritis, arthrosis
- A61P 27/02: Ophthalmic agents
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- C07K 14/78: Connective tissue peptides, e.g. collagen, elastin, laminin, fibronectin, vitronectin or cold insoluble globulin [CIG]
- A61K 31/351: not condensed with another ring
- A61K 31/497: containing further heterocyclic rings
- A61K 2300/00: Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
- A61L 2400/12: Nanosized materials, e.g. nanofibres, nanoparticles, nanowires, nanotubes; Nanostructured surfaces
- A61P 17/00: Drugs for dermatological disorders
- A61P 35/00: Antineoplastic agents
- 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)
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)
- 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)

## Abstract

The present invention is in the fields of medicinal chemistry, biotechnology and pharmaceuticals. The invention provides compositions comprising one or more collagen mimetic peptides, optionally attached to one or more therapeutic compounds or one or more imaging compounds, for use in methods of treating, preventing, ameliorating, curing and diagnosing certain diseases and physical disorders in humans and veterinary animals, as well as methods of manufacturing such composition. The invention also provides medical devices comprising one or more such compositions of the invention. The invention also provides methods of use of such compositions and devices in treating and diagnosing certain diseases and physical disorders in humans and veterinary animals, including ocular diseases or disorders, skin diseases or disorders, certain cancers, particularly intraluminal cancers, gastrointestinal diseases or disorders, genitourinary tract diseases or disorders, fibrotic diseases/disorders and rheumatic diseases/disorders.

## Claims

### Claim 1

A method of treating an ocular disease, disorder or wound selected from the group consisting of cataracts, vitreous adhesions or floaters, macular degeneration, non-infectious corneal ulceration, non-infectious corneal melting, infectious corneal ulceration, infectious corneal melting, Stevens-Johnson Syndrome, scleritis, episcleritis, ectasia, keratoconus, and post-operative afflictions of the eye resulting from eye surgery, in a human or veterinary animal suffering from said ocular disease, disorder or wound, comprising administering a composition comprising (a) at least one collagen mimetic peptide (CMP) comprising the amino acid sequence of SEQ ID NO: 1, and (b) one or more pharmaceutically suitable carriers to an eye of said human or veterinary animal in a dosage sufficient to treat said ocular disease, disorder or wound, monitoring the condition of the eye in said human or veterinary animal over time, and readministering said composition to the eye until said ocular disease, disorder or wound is treated or ameliorated.

### Claim 2 (depends on 1)

The method of claim 1, wherein said ocular disease, disorder or wound is selected from the group consisting of scleritis, episcleritis, keratoconus, cataracts and post-operative afflictions of the eye resulting from eye surgery.

### Claim 3 (depends on 2)

The method of claim 2, wherein said ocular disease, disorder or wound is keratoconus.

### Claim 4 (depends on 2)

The method of claim 2, wherein said ocular disease, disorder or wound is scleritis.

### Claim 5 (depends on 2)

The method of claim 2, wherein said ocular disease, disorder or wound is episcleritis.

### Claim 6 (depends on 2)

The method of claim 2, wherein said ocular disease, disorder or wound is post-operative afflictions of the eye resulting from eye surgery.

### Claim 7 (depends on 1)

The method of claim 1, wherein said composition is administered to the eye conjunctivally or subconjunctivally.

### Claim 8 (depends on 7)

The method of claim 7, wherein said subconjunctival administration is achieved by administering said composition into the subconjunctival fornix.

### Claim 9 (depends on 1)

The method of claim 1, wherein said composition is administered to the eye in the form of one or more drops of solution or a suspension that contains the composition.

### Claim 10 (depends on 1)

The method of claim 1, wherein said composition is administered to the eye via injection.

### Claim 11 (depends on 1)

The method of claim 1, wherein said composition is administered to the eye in the form of a coating on a solid material that is implanted into an eye structure.

### Claim 12 (depends on 1)

The method of claim 1, wherein said composition is administered to the eye in the form of a wafer, film, gel, mesh or patch.

### Claim 13 (depends on 1)

The method of claim 1, wherein said composition is attached to one or more spheres or nanoparticles that are delivered to or into an eye structure.

### Claim 14 (depends on 1)

The method of claim 1, wherein said collagen mimetic peptide is attached to at least one therapeutic compound (TC) to form a CMP-TC conjugate.

### Claim 15 (depends on 14)

The method of claim 14, wherein said at least one therapeutic compound comprises at least one reactive hydroxyl group capable of being cross-linked to said collagen mimetic peptide.

### Claim 16 (depends on 15)

The method of claim 15, wherein said at least one therapeutic compound is directly attached to said collagen mimetic peptide via an amino group on said collagen mimetic peptide linked to a hydroxyl group on said therapeutic compound.

### Claim 17 (depends on 14)

The method of claim 14, wherein said at least one therapeutic compound is selected from the group consisting of a steroidal anti-inflammatory drug, a nonsteroidal anti-inflammatory drug, a topical anesthetic, a vitamin or a derivative or precursor thereof, therapeutic enzyme or a therapeutic fragment thereof, an antibiotic, a therapeutic monoclonal antibody or a therapeutic fragment thereof, a therapeutic fusion protein, a prostaglandin analogue, a growth factor, a neuropeptide, an α-adrenergic antagonist, a β-adrenergic antagonist, a cell surface receptor antagonist, a carbonic anhydrase inhibitor, and pharmaceutically acceptable salts, esters and derivatives thereof.

### Claim 18 (depends on 17)

The method of claim 17, wherein said prostaglandin analogue is selected from the group consisting of latanoprost, travoprost, tafluprost, unoprostone, tatanoprostene bunod and bimatoprost, and pharmaceutically acceptable salts, esters and derivatives thereof.

### Claim 19 (depends on 18)

The method of claim 18, wherein said prostaglandin analogue is latanoprost.

### Claim 20 (depends on 14)

The method of claim 14, wherein said collagen mimetic peptide is covalently attached directly to said at least one therapeutic compound.

### Claim 21 (depends on 14)

The method of claim 14, wherein said collagen mimetic peptide is indirectly attached to said at least one therapeutic compound via use of an attachment means.

### Claim 22 (depends on 21)

The method of claim 21, wherein said attachment means comprises at least one polymeric chain having a first end and a second end.

### Claim 23 (depends on 22)

The method of claim 22, wherein said polymeric chain is a linear polyethyleneglycol chain comprising at least four ethyleneglycol monomers.

### Claim 24 (depends on 23)

The method of claim 23, wherein said polymeric chain comprises from twenty to twenty-five ethyleneglycol monomers.

### Claim 25 (depends on 14)

The method of claim 14, wherein said collagen mimetic peptide comprises at least one biotin moiety and said therapeutic molecule comprises at least one avidin or streptavidin moiety, and wherein said biotin moiety on said collagen mimetic peptide binds to said avidin or streptavidin moiety on said therapeutic compound, thereby attaching said collagen mimetic peptide to said therapeutic compound.

### Claim 26 (depends on 14)

The method of claim 14, wherein said collagen mimetic peptide comprises at least one avidin or streptavidin moiety and said therapeutic molecule comprises at least one biotin moiety, and wherein said avidin or streptavidin moiety on said collagen mimetic peptide binds to said biotin moiety on said therapeutic compound, thereby attaching said collagen mimetic peptide to said therapeutic compound.