# US 2021/0330720 A1 · Composition and methods for microbiota therapy

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- Number: US 2021/0330720 A1
- Document ID: US20210330720A1
- Status: Published application
- Kind: A1
- Application number: 17/368,494
- Filed: 2021-07-06
- Published: 2021-10-28
- Earliest claimed: 2016-05-25
- Assignees: Mybiotics Pharma Ltd.
- Applicants: Mybiotics Pharma Ltd.
- Inventors: David Baram; David Daboush; Rachel Diamant
- Web page: https://patentgrep.com/patent/US20210330720A1

## CPC

- A61K 35/745: Bifidobacteria
- A61K 35/74: Bacteria (therapeutic use of a bacterial protein A61K38/00)
- A61K 35/741: Probiotics (probiotic yeast, e.g. saccharomyces A61K36/06)
- A61K 35/744: Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs
- A61K 35/747: Lactobacilli, e.g. L. acidophilus or L. brevis
- A61P 1/00: Drugs for disorders of the alimentary tract or the digestive system
- C12N 1/20: Bacteria; Culture media therefor
- C12N 11/02: Enzymes or microbial cells immobilised on or in an organic carrier
- C12N 11/14: Enzymes or microbial cells immobilised on or in an inorganic carrier
- 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)
- Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE

## Abstract

The present invention provides a composition comprising a co-culture of at least two distinct bacterial families, having differing growth and/or proliferative conditions. In some embodiments, the composition comprises a plurality of bacterial genera with high similarity to microbial flora.

## Claims

### Claim 1

A synthetic composition comprising a plurality of bacteria, wherein the plurality of bacteria is a bacteria co-culture at least partially grown on a particle, and comprises at least two distinct bacteria having differing growth and/or proliferative conditions; and wherein the composition comprises at least 30% of bacterial phylum or 30% of bacterial genera listed under Table 8.

### Claim 2 (depends on 1)

The synthetic composition of claim 1, wherein the at least two distinct bacteria are from one or more taxonomic classification.

### Claim 3 (depends on 1)

The synthetic composition of claim 1, further comprising a particle, and wherein the co-culture is at least partially attached to the particle.

### Claim 4 (depends on 1)

The synthetic composition of claim 1, comprising at least 70% of the bacterial phylum or 70% of the bacterial genera.

### Claim 5 (depends on 1)

The synthetic composition of claim 1, further comprising Archaea.

### Claim 6 (depends on 1)

The synthetic composition of claim 1, wherein said differing growth and/or proliferative conditions comprises a first condition allowing substantially optimal growth, proliferate and cultivation of a first bacteria; and a second condition allowing substantially optimal growth, proliferate and cultivation of a second bacteria.

### Claim 7 (depends on 1)

The synthetic composition of claim 1, wherein the at least two distinct bacteria having differing growth and/or proliferative conditions are from bacterial subsets selected from the group consisting of: aerobic bacteria, anaerobic bacteria and microaerophilic bacteria.

### Claim 8 (depends on 1)

The synthetic composition of claim 1, wherein the distinct bacteria are from different groups selected from aerobic bacteria, anaerobic bacteria or microaerophilic bacteria.

### Claim 9 (depends on 1)

The synthetic composition of claim 1, comprising at least one bacterial subset in the form of biofilm and at least one bacterial subset of planktonic bacteria.

### Claim 10 (depends on 1)

The synthetic composition of claim 1, wherein at least a portion of the co-culture is in syntrophic relationship.

### Claim 11 (depends on 1)

The synthetic composition of claim 1, wherein said bacteria are selected from the group consisting of: a gut microbiota, a saliva microbiota, a skin microbiota, an oral microbiota, a bronchial microbiota, a vaginal microbiota, an upper respiratory tract microbiota, an urogenital tract microbiota, a fecal bacteria, a soil microbiota, a ground water microbiota, an open waters microbiota and a mixture thereof.

### Claim 12 (depends on 1)

The synthetic composition of claim 1, wherein said plurality of bacteria is derived from one or more samples selected from the group consisting of: a fecal sample, a saliva sample, a skin sample, an oral sample, a bronchial sample, a vaginal sample, and a soil sample.

### Claim 13 (depends on 1)

The synthetic composition of claim 1, wherein the plurality of bacteria is derived from at least one origin.

### Claim 14 (depends on 1)

The synthetic composition of claim 1, wherein the plurality of bacteria is derived from one or more of mammal donor, animal donor, bacterial strain, stored microbiota sample, bacterial colony, planktonic sample and a biofilm.

### Claim 15 (depends on 1)

The synthetic composition of claim 1, comprising one or more types of particles, and wherein the co-culture is at least partially attached to each particle.

### Claim 16 (depends on 1)

The synthetic composition of claim 1, further comprising a pharmaceutically acceptable carrier or excipient.

### Claim 17 (depends on 16)

The synthetic composition according to claim 16, formulated for administration by a mode selected from the group consisting of rectal, intravenous, parenteral, mucosal, vaginal, nasal, local, systemic, oral administration, and a combination thereof

### Claim 18 (depends on 1)

A method of treating a disease or a disorder in a subject in need thereof, the method comprises administering to the subject the synthetic composition of claim 1.

### Claim 19 (depends on 18)

The method of claim 18, wherein said disease or disorder is dysbiosis.

### Claim 20 (depends on 1)

A method for obtaining the synthetic composition of claim 1, the method comprising the steps of: providing a plurality of bacteria; incubating the plurality of bacteria with at least one particle, and allowing the plurality of the bacteria to at least partially attach to the particle; dividing the plurality of bacteria that are at least partially attached to the particle into a plurality of bacterial solution subsets; culturing the bacterial subsets in different growth medium and/or proliferative conditions suitable for the growth and/or proliferation of the subset; and recombining the bacterial solution subsets,
thereby obtaining the synthetic composition comprising a co-culture of at least two distinct bacteria having differing growth and/or proliferative conditions; and comprising at least 30% of bacterial phylum or 30% of bacterial genera listed under Table 8.
