# US 10,500,237 B2 · Compositions comprising bacterial strains

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- Number: US 10,500,237 B2
- Document ID: US10500237B2
- Status: Granted
- Kind: B2
- Application number: 15/842,635
- Filed: 2017-12-14
- Published: 2018-05-17
- Granted: 2019-12-10
- Earliest claimed: 2015-06-15
- Assignees: 4D Pharma Research Limited
- Applicants: 4D Pharma Research Limited
- Inventors: Alex Stevenson
- Web page: https://patentgrep.com/patent/US10500237B2

## 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)}
- A61P 11/06: Antiasthmatics
- A61P 19/02: for joint disorders, e.g. arthritis, arthrosis
- A61P 37/00: Drugs for immunological or allergic disorders
- C12N 1/205: Bacterial isolates
- C12R 2001/01: Bacteria or Actinomycetales {; using bacteria or Actinomycetales}
- 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

Provided are pharmaceutical compositions that comprise bacteria strains of the genus Roseburia for treating inflammatory and autoimmune diseases. Also provided are methods of treating inflammatory and autoimmune diseases using pharmaceutical compositions that comprise bacteria strains of the genus Roseburia. Inflammatory and autoimmune diseases for treatment with the disclosed pharmaceutical compositions can include asthma.

## Claims

### Claim 1

A method of treating an asthma in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of a pharmaceutical composition that comprises a bacteria strain of the genus Roseburia, wherein the bacteria strain comprises the 16s rRNA gene sequence of SEQ ID NO:3.

### Claim 2

A method of treating an asthma in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of a pharmaceutical composition that comprises a bacteria strain of the genus Roseburia, wherein the bacteria strain is a Roseburia hominis strain 433 deposited with the NCIMB under accession number NCIMB 42383.

### Claim 3 (depends on 1)

The method of claim 1, wherein the asthma is selected from the group consisting of neutrophilic asthma, allergic asthma, and a combination thereof.

### Claim 4 (depends on 1)

The method of claim 1, wherein the administering reduces the level of neutrophils or eosinophils in a lung tissue of the subject, as compared to a level prior to the administering.

### Claim 5 (depends on 1)

The method of claim 1, wherein the administering reduces inflammation in a lung tissue of the subject, as compared to prior to the administering.

### Claim 6 (depends on 1)

The method of claim 1, wherein the administering reduces an amount of at least one pro-inflammatory cytokine in a lung tissue of the subject, as compared to prior to the administering.

### Claim 7 (depends on 6)

The method of claim 6, wherein the pro-inflammatory cytokine is associated with the Th17 pathway.

### Claim 8 (depends on 6)

The method of claim 6, wherein the pro-inflammatory cytokine is selected from the group consisting of IL-9, IL-1, IFN-γ, IL-17, IL-4, IL-5, RANTES, MIP-la, KC, and MIP-2.

### Claim 9 (depends on 1)

The method of claim 1, wherein the administering is oral.

### Claim 10 (depends on 1)

The method of claim 1, wherein the therapeutically effective amount comprises from about 1 ×103 to about 1 ×1011 CFU/g of the bacteria strain with respect to a total weight of the pharmaceutical composition.

### Claim 11 (depends on 1)

The method of claim 1, wherein the subject is human.

### Claim 12 (depends on 2)

The method of claim 2, wherein the asthma is selected from the group consisting of neutrophilic asthma, allergic asthma, and a combination thereof.

### Claim 13 (depends on 2)

The method of claim 2, wherein the administering reduces the level of neutrophils or eosinophils in a lung tissue of the subject, as compared to a level prior to the administering.

### Claim 14 (depends on 2)

The method of claim 2, wherein the administering reduces inflammation in a lung tissue of the subject, as compared to prior to the administering.

### Claim 15 (depends on 2)

The method of claim 2, wherein the administering reduces an amount of at least one pro-inflammatory cytokine in a lung tissue of the subject, as compared to prior to the administering.

### Claim 16 (depends on 15)

The method of claim 15, wherein the pro-inflammatory cytokine is associated with the Th17 pathway.

### Claim 17 (depends on 15)

The method of claim 15, wherein the pro-inflammatory cytokine is selected from the group consisting of IL-9, IL-1, IFN-γ, IL-17, IL-4, IL-5, RANTES, MIP-1a, KC, and MIP-2.

### Claim 18 (depends on 2)

The method of claim 2, wherein the administering is oral.

### Claim 19 (depends on 2)

The method of claim 2, wherein the therapeutically effective amount comprises from about 1 ×103 to about 1 ×1011 CFU/g of the bacteria strain with respect to a total weight of the pharmaceutical composition.

### Claim 20 (depends on 2)

The method of claim 2, wherein the subject is human.
