# US 11,896,628 B2 · Methods and compositions for the treatment of C. difficile

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 11,896,628 B2
- Document ID: US11896628B2
- Status: Granted
- Kind: B2
- Application number: 17/856,013
- Filed: 2022-07-01
- Published: 2023-04-27
- Granted: 2024-02-13
- Earliest claimed: 2018-06-07
- Assignees: Artugen Therapeutics Ltd.
- Applicants: Artugen Therapeutics Ltd.
- Inventors: Ronald Farquhar; Christopher K. Murphy; Colin Hill; Paul Ross; Mary Rea; Michelle O'Donnell; Brian Healy; Laurent Chesnel
- Web page: https://patentgrep.com/patent/US11896628B2

## CPC

- A61K 35/74: Bacteria (therapeutic use of a bacterial protein A61K38/00)
- 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 47/36: Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61P 1/12: Antidiarrhoeals
- C12N 1/205: Bacterial isolates
- C12R 2001/07: Bacillus
- Y02A 50/30: Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
- 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
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)
- C12R: INDEXING SCHEME ASSOCIATED WITH SUBCLASSES C12C - C12Q, RELATING TO MICROORGANISMS
- Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE

## Abstract

Disclosed herein are compositions and methods for preventing, ameliorating, or treating Clostridium difficile infections and/or reducing the severity of one or more risk factors, signs, or symptoms associated with C. difficile infections. In particular, the technology of the present disclosure relates to methods for administering an effective amount of a composition comprising strains of Bacillus amyloliquefaciens bacteria identified as ART24, ART4, and ART 12, to a subject suffering from or at risk for C. difficile infections.

## Claims

### Claim 1

A method of preparing a therapeutic composition, comprising, combining one or more bacterial strains selected from the group consisting of ART24 (NCIMB Accession No. 43088), ART4 (NCIMB Accession No. 43086), and ART12 (NCIMB Accession No. 43087) With a preservative.

### Claim 2 (depends on 1)

The method of claim 1, wherein the bacterial strain is ART24 (NCIMB Accession No. 43088).

### Claim 3 (depends on 1)

The method of claim 1, wherein the bacterial strain is ART4 (NCIMB Accession No. 43086).

### Claim 4 (depends on 1)

The method of claim 1, wherein the bacterial strain is ART 12 (NCIMB Accession No. 43087).

### Claim 5 (depends on 1)

The method of claim 1, wherein the preservative is selected from the group consisting of sucrose, trehalose, sodium ascorbate, and glutathione.

### Claim 6 (depends on 1)

The method of claim 1, wherein the preservative is a cryoprotectant.

### Claim 7 (depends on 6)

The method of claim 6, wherein the cryoprotectant is selected from the group consisting of a nucleotide, a disaccharide, a polyol, and a polysaccharide.

### Claim 8 (depends on 6)

The method of claim 6, wherein the cryoprotectant is selected from the group consisting of inosine-5′-monophosphate (IMP), guanosine-5′-monophosphate (GMP), adenosine-5′-monophosphate (AMP), uranosine-5′-monophosphate (UMP), cytidine-5′-monophosphate (CMP), adenine, guanine, uracil, cytosine, guanosine, uridine, cytidine, hypoxanthine, xanthine, orotidine, thymidine, inosine, trehalose, maltose, lactose, sucrose, sorbitol, mannitol, dextrin, inulin, sodium ascorbate, glutathione, and skim milk.

### Claim 9 (depends on 8)

The method of claim 8, wherein the cryoprotectant comprises trehalose.

### Claim 10 (depends on 1)

The method of claim 1, wherein the one or more bacterial strains are in spore form.

### Claim 11 (depends on 10)

The method of claim 10, wherein the one or more bacterial strains are sporulated using nutrient exhaustion media.

### Claim 12 (depends on 10)

The method of claim 10, wherein the one or more sporulated bacterial strains exhibit acid tolerance.

### Claim 13 (depends on 12)

The method of claim 12, wherein the one or more sporulated bacterial strains exhibit gastric fluid tolerance.

### Claim 14 (depends on 1)

The method of claim 1, wherein the one or more bacterial strains are lyophilized.

### Claim 15 (depends on 14)

The method of claim 14, wherein the one or more lyophilized bacterial strains are resuspended in a solution containing the preservative.