# US 2026/0083641 A1 · Compositions comprising collagenase and uses thereof in orthodontic procedures

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- Number: US 2026/0083641 A1
- Document ID: US20260083641A1
- Status: Published application
- Kind: A1
- Application number: 19/404,309
- Filed: 2025-12-01
- Published: 2026-03-26
- Earliest claimed: 2023-06-13
- Assignees: Ramot at Tel-Aviv University Ltd.
- Applicants: Ramot At Tel Aviv University Ltd.
- Inventors: Maayan GAL; Orel COHEN; Diva LUGASSY; Itzhak BINDERMAN; Evgeny WEINBERG
- Web page: https://patentgrep.com/patent/US20260083641A1

## CPC

- A61K 6/50: Preparations specially adapted for dental root treatment
- A61K 38/4886: {Metalloendopeptidases (3.4.24), e.g. collagenase}
- A61K 6/69: Medicaments
- A61L 27/54: Biologically active materials, e.g. therapeutic substances {(A61L27/227 takes precedence)}
- C12N 9/52: derived from bacteria {or Archaea}
- C12Y 304/24003: Microbial collagenase (3.4.24.3)
- A61L 2300/254: Enzymes, proenzymes
- A61L 2400/06: Flowable or injectable implant compositions
- C12R 2001/145: Clostridium
- 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)
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)
- C12Y: ENZYMES
- C12R: INDEXING SCHEME ASSOCIATED WITH SUBCLASSES C12C - C12Q, RELATING TO MICROORGANISMS

## Abstract

Provided herein compositions including collagenase, and uses thereof in orthodontic procedures, wherein the compositions may include recombinant collagenase and/or modified forms of recombinant collagenase having amino acid(s) truncation or substitutions.

## Claims

### Claim at position 1

-44. (canceled)

### Claim 45

A method of performing an orthodontic procedure in a subject in need thereof, the method comprising administering to the subject in need thereof an effective amount of a recombinant collagenase polypeptide, or a composition comprising the same.

### Claim 46 (depends on 45)

The method of claim 45, wherein the orthodontic procedure comprises one or more procedures selected from accelerated orthodontic tooth movement (OTM), post-orthodontic relapse prevention and teeth alignment, or any combination thereof.

### Claim 47 (depends on 45)

The method according to claim 45, wherein the recombinant collagenase comprises one or more collagenases selected from: a full-length WT collagenase, N-terminally truncated un-modified collagenase, and N-terminally truncated modified collagenase, or any combination thereof.

### Claim 48 (depends on 45)

The method according to claim 45, wherein the recombinant collagenase comprises an amino acid sequence having at least about 65% sequence identity to an amino acid sequence of a reference collagenase; wherein the reference collagenase comprises one or more collagenases selected from: a full-length WT collagenase having an amino acid sequence as denoted by SEQ ID NO:8, an N-terminal truncated collagenase having amino acid sequence as denoted by SEQ ID NO: 1 or SEQ ID NO: 9, N-terminally truncated modified collagenase having amino acid sequence as denoted by any one of SEQ ID NOs: 2-7; or any combination thereof.

### Claim 49 (depends on 48)

The method according to claim 48, wherein the collagenase comprises an amino acid sequence having at least about 65% sequence identity to an amino acid sequence of the N-terminally truncated reference collagenase having amino acid sequence as denoted by SEQ ID NO: 1 or SEQ ID NO: 9.

### Claim 50 (depends on 45)

The method according to claim 45, wherein the collagenase originates from Clostridium H (histolyticum) and/or Clostridium T (Tetani).

### Claim 51 (depends on 45)

The method according to claim 45, wherein the collagenase polypeptide has an amino acid sequence having at least about 80% sequence similarity to an amino acid sequence as denoted by SEQ ID NO: 1 and/or SEQ ID NO: 9.

### Claim 52 (depends on 45)

The method according to claim 45, wherein the collagenase polypeptide has an amino acid sequence as denoted by SEQ ID NO: 1 and/or SEQ ID NO: 9.

### Claim 53 (depends on 45)

The method according to claim 45, wherein the collagenase polypeptide comprises an amino acid sequence having at least 80% similarity to an amino acid sequence denoted by any one of SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 4, SEQ ID NO: 5, SEQ ID NO: 6, SEQ ID NO: 7, or any combination thereof.

### Claim 54 (depends on 45)

The method according to claim 45, wherein the collagenase polypeptide comprises an amino acid sequence as denoted by any one of SEQ ID NOs: 1-9.

### Claim 55 (depends on 45)

The method according to claim 45, wherein the collagenase polypeptide comprises an amino acid sequence as denoted by SEQ ID NO: 2 ad/or SEQ ID NO: 5.

### Claim 56 (depends on 45)

The method according to claim 45, wherein the administration is local administration.

### Claim 57 (depends on 45)

The method according to claim 45, wherein the administration is by injection.

### Claim 58 (depends on 45)

The method according to claim 45, wherein the administration is to a connective tissue of marginal gingiva (lamina propria).

### Claim 59 (depends on 45)

The method according to claim 45, wherein the recombinant collagenase polypeptide or the composition comprising the same are capable of affecting gingival fibers.

### Claim 60 (depends on 45)

The method according to claim 45, wherein the recombinant collagenase polypeptide is administered at an effective amount of at least about 1.2 mg/ml.

### Claim 61 (depends on 45)

The method according to claim 45, wherein the recombinant collagenase polypeptide is administered at an effective amount of at least about 4 mg/ml.

### Claim 62 (depends on 45)

The method according to claim 45 wherein the orthodontic procedure utilizing the recombinant collagenase polypeptide or the composition comprising the same, provides equal or enhanced effect on tooth movement (mm), compared to same orthodontic procedure utilizing surgical fiberotomy; and wherein the orthodontic procedure comprises accelerated orthodontic tooth movement (OTM).

### Claim 63 (depends on 45)

The method according to claim 45, wherein the orthodontic procedure utilizing the recombinant collagenase polypeptide or the composition comprising the same, provides equal or improved reduction in relapse compared to relapse after same orthodontic procedure utilizing surgical fiberotomy; and wherein the orthodontic procedure comprises prevention of post-orthodontic relapse.
