# US 2021/0330764 A1 · Collagenase Clostridium Histolyticum Injection Therapies

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- Number: US 2021/0330764 A1
- Document ID: US20210330764A1
- Status: Published application
- Kind: A1
- Application number: 17/066,462
- Filed: 2020-10-08
- Published: 2021-10-28
- Earliest claimed: 2020-04-24
- Assignees: InnoMed Technologies, Inc.
- Applicants: InnoMed Technologies, Inc.
- Inventors: John Joseph
- Web page: https://patentgrep.com/patent/US20210330764A1

## CPC

- A61K 38/4886: {Metalloendopeptidases (3.4.24), e.g. collagenase}
- 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 9/08: Solutions {(composition of solutions A61K47/00)}
- A61K 9/19: lyophilised {, i.e. freeze-dried, solutions or dispersions (lyophilised products with subsequent particle size reduction A61K9/14; granules or pellets made by lyphilisation A61K9/1682; solid oral dosage forms made by lyophilisation A61K9/2095; lyophilisation additives A61K47/00)}
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61K 47/26: Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
- A61P 11/00: Drugs for disorders of the respiratory system
- A61P 13/08: of the prostate
- 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

Collagenase Clostridium Histolyticum (EN3835) is a proteinase that can hydrolyze the triple-helical region of collagen under physiological conditions. EN3835 targets the collagenase structural matrix at the site of injection and does not require systemic exposure. Embodiments include methods of lysing subdermal collagen to treat various conditions such as benign prostatic hyperplasia, tracheal stenosis, subglottic stenosis and scleroderma.

## Claims

### Claim 1

A method of reducing localized collagen tissue in a patient comprising injection of collagenase clostridium histolyticum at or near the localized collagen tissue.

### Claim 2 (depends on 1)

The method of claim 1, wherein the localized collagen tissue is scar tissue.

### Claim 3 (depends on 1)

The method of claim 1, wherein the localized collagen tissue is a subglottic or tracheal stenosis.

### Claim 4 (depends on 1)

The method of claim 1, wherein the localized collagen tissue is formed from an autoimmune disease.

### Claim 5 (depends on 4)

The method of claim 4, including a wherein the autoimmune disease is scleroderma.

### Claim 6 (depends on 1)

The method of claim 1, wherein a total of 0.01 mg to 0.5 mg of collagenase clostridium histolyticum in solution is injected.

### Claim 7 (depends on 1)

The method of claim 1, wherein a total of 0.02 mg to 0.05 mg of collagenase clostridium histolyticum in solution is injected.

### Claim 8

A method of treating a patient with tracheal stenosis comprising a step of injecting collagenase clostridium histolyticum.

### Claim 9 (depends on 8)

The method of claim 8, wherein the tracheal stenosis is associated with tracheal intubation.

### Claim 10 (depends on 8)

The method of claim 8, including an additional step of endoscopic dilation.

### Claim 11 (depends on 8)

The method of claim 8, wherein a total of 0.02 mg to 0.5 mg of collagenase clostridium histolyticum in solution is injected.

### Claim 12

A method of treating a patient with subglottic stenosis comprising injecting collagenase clostridium histolyticum.

### Claim 13 (depends on 12)

The method of claim 12, wherein the subglottic stenosis is associated with tracheal intubation.

### Claim 14 (depends on 12)

The method of claim 12, including an additional step of endoscopic dilation.

### Claim 15 (depends on 12)

The method of claim 12, wherein a total of 0.02 mg to 0.5 mg of collagenase clostridium histolyticum in solution is injected.

### Claim 16

A method of treating a patient with esophageal stricture comprising a step of injecting collagenase clostridium histolyticum.

### Claim 17 (depends on 16)

The method of claim 16, wherein the esophageal stricture is associated with scleroderma.

### Claim 18 (depends on 16)

The method of claim 16, including an additional step of endoscopic dilation.

### Claim 19 (depends on 16)

The method of claim 16, wherein a total of 0.02 mg to 0.5 mg of collagenase clostridium histolyticum in solution is injected.