# US 2025/0375485 A1 · Compositions for metabolic health

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- Number: US 2025/0375485 A1
- Document ID: US20250375485A1
- Status: Published application
- Kind: A1
- Application number: 19/188,911
- Filed: 2025-04-24
- Published: 2025-12-11
- Earliest claimed: 2020-04-03
- Assignees: International N&H Denmark Aps
- Applicants: International N&H Denmark ApS
- Inventors: Sofia FORSSTEN; Oliver HASSELWANDER; Ashley Ann HIBBERD; Henrik Max JENSEN; Helene M A KANE; Hye-Sook KIM; Ritesh KUMAR; Arthur OUWEHAND; Pia Tuulikki RASINKANGAS; Pierre E ROUVIERE; Buffy L STAHL; Qiong WANG
- Web page: https://patentgrep.com/patent/US20250375485A1

## CPC

- A23L 33/135: Bacteria or derivatives thereof, e.g. probiotics
- A61K 35/741: Probiotics (probiotic yeast, e.g. saccharomyces A61K36/06)
- A23L 29/065: {Microorganisms (addition of bacteria for nutritional purposes A23L33/135)}
- A61K 9/16: Agglomerates; Granulates; Microbeadlets {; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction (A61K9/20 takes precedence if the final form is a tablet; microspheres with drug-free outer coating, microcapsules A61K9/50; mixture of different granules, microcapsules, (coated) microparticles A61K9/5084; nanoparticles A61K9/51)}
- A61P 3/04: Anorexiants; Antiobesity agents
- A61P 3/08: for glucose homeostasis (pancreatic hormones A61P5/48)
- A61P 3/10: for hyperglycaemia, e.g. antidiabetics
- C12N 1/205: Bacterial isolates
- C12R 2001/01: Bacteria or Actinomycetales {; using bacteria or Actinomycetales}
- Y02E 50/10: Biofuels, e.g. bio-diesel
- A23L: FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF (preservation thereof A23B)
- 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
- Y02E: REDUCTION OF GREENHOUSE GAS [GHG] EMISSIONS, RELATED TO ENERGY GENERATION, TRANSMISSION OR DISTRIBUTION

## Abstract

Provided herein, inter alia, are compositions comprising one or more biologically pure strains of bacteria as well as methods of making and using the same to treat and/or prevent one or more obesity related disorders in a subject in need thereof.

## Claims

### Claim 1

A composition comprising at least one or more of (a) a biologically pure strain of Eubacterium eligens; (b) a biologically pure strain of Intestinimonas massiliensis; (c) a bacterial strain having a 16S ribosomal RNA sequence displaying at least 97.0% sequence similarity to a 16S ribosomal RNA sequence of Prevotella copri deposited at the German Collection of Microorganisms and Cell Cultures (DSM) under number DSM 33457; and/or (d) a biologically pure strain of an Akkermansia sp., wherein said Akkermansia sp. is not (i) Akkermansia muciniphila; or (ii) Akkermansia glycaniphilia.

### Claim 2 (depends on 1)

The composition of claim 1, wherein genome-wide average nucleotide identity (gANI) between said Akkermansia sp. and (i) Akkermansia muciniphila; or (ii) Akkermansia glycaniphilia is less than about 95%.

### Claim 3 (depends on 1, 2)

The composition of claim 1 or claim 2, comprising (a) a bacterial strain having a 16S ribosomal RNA sequence displaying at least 97.0% sequence similarity to a 16S ribosomal RNA sequence of E. eligens deposited at DSM under number DSM 33458; and/or (b) a bacterial strain having a 16S ribosomal RNA sequence displaying at least 97.0% sequence similarity to a 16S ribosomal RNA sequence of I. massiliensis deposited at DSM under number DSM 33460.

### Claim 4 (depends on 1, 2, 3)

The composition of any one of claims 1-3, comprising (a) the E. eligens strain deposited at DSM under number DSM 33458 or a live strain having all of the identifying characteristics of the E. eligens strain deposited at DSM under number DSM 33458; (b) the I. massiliensis strain deposited at DSM under number DSM 33460 or a live strain having all of the identifying characteristics of the I. massiliensis strain deposited at DSM under number DSM 33460; (c) the P. copri strain deposited at DSM under number DSM 33457 or a live strain having all of the identifying characteristics of the P. copri strain deposited at DSM under number DSM 33457; and/or (d) the Akkermansia sp. deposited at DSM under number DSM 33459 or a live strain having all of the identifying characteristics of the Akkermansia sp. deposited at DSM under number DSM 33459 either (A) alone; and/or (B) in combination with a culture supernatant derived from one or more of these strains.

### Claim 5 (depends on 1)

The composition of claim 1, comprising (b) a biologically pure strain of Intestinimonas massiliensis; and (d) a biologically pure strain of an Akkermansia sp., wherein said Akkermansia sp. is not (i) Akkermansia muciniphila; or (ii) Akkermansia glycaniphilia.

### Claim 6 (depends on 5)

The composition of claim 5, comprising (b) a bacterial strain having a 16S ribosomal RNA sequence displaying at least 97.0% sequence similarity to a 16S ribosomal RNA sequence of I. massiliensis deposited at DSM under number DSM 33460.

### Claim 7 (depends on 5, 6)

The composition of claim 5 or claim 6, wherein genome-wide average nucleotide identity (gANI) between said Akkermansia sp. and (i) Akkermansia muciniphila; or (ii) Akkermansia glycaniphilia is less than about 95%.

### Claim 8 (depends on 5, 6, 7)

The composition of any one of claims 5-7, comprising (b) the I. massiliensis strain deposited at DSM under number DSM 33460or a live strain having all of the identifying characteristics of the I. massiliensis strain deposited at DSM under number DSM 33460; and (d) the Akkermansia sp. deposited at DSM under number DSM 33459or a live strain having all of the identifying characteristics of the Akkermansia sp. deposited at DSM under number DSM 33459.

### Claim 9

A composition comprising isolated bacterial extracellular vesicles (EVs) derived from at least one or more of (a) a biologically pure strain of Eubacterium eligens; (b) a biologically pure strain of Intestinimonas massiliensis; (c) a bacterial strain having a 16S ribosomal RNA sequence displaying at least 97.0% sequence similarity to a 16S ribosomal RNA sequence of Prevotella copri deposited at the German Collection of Microorganisms and Cell Cultures (DSM) under number DSM 33457; and/or (d) a biologically pure strain of an Akkermansia sp., wherein said Akkermansia sp. is not (i) Akkermansia muciniphila; or (ii) Akkermansia glycaniphilia.

### Claim 10 (depends on 9)

The composition of claim 9, further comprising one or more bacteria from (a), (b), (c), and/or (d).

### Claim 11 (depends on 9, 10)

The composition of claim 9 or claim 10, wherein genome-wide average nucleotide identity (gANI) between said Akkermansia sp. and (i) Akkermansia muciniphila; or (ii) Akkermansia glycaniphilia is less than about 95%.

### Claim 12 (depends on 9, 10, 11)

The composition of any one of claims 9-11, comprising (a) EVs derived from a bacterial strain having a 16S ribosomal RNA sequence displaying at least 97.0% sequence similarity to a 16S ribosomal RNA sequence of E. eligens deposited at DSM under number DSM 33458; and/or (b) EVs derived from a bacterial strain having a 16S ribosomal RNA sequence displaying at least 97.0% sequence similarity to a 16S ribosomal RNA sequence of I. massiliensis deposited at DSM under number DSM 33460.

### Claim 13 (depends on 9, 10, 11, 12)

The composition of any one of claims 9-12, comprising (a) EVs derived from the E. eligens strain deposited at DSM under number DSM 33458 or a live strain having all of the identifying characteristics of the E. eligens strain deposited at DSM under number DSM 33458; (b) EVs derived from the I. massiliensis strain deposited at DSM under number DSM 33460or a live strain having all of the identifying characteristics of the I. massiliensis strain deposited at DSM under number DSM 33460; (c) EVs derived from the P. copri strain deposited at DSM under number DSM 33457 or a live strain having all of the identifying characteristics of the P. copri strain deposited at DSM under number DSM 33457; and/or (d) EVs derived from the Akkermansia sp. deposited at DSM under number DSM 33459 or a live strain having all of the identifying characteristics of the Akkermansia sp. deposited at DSM under number DSM 33459 either (A) alone; and/or (B) in combination with a culture supernatant derived from one or more of these strains.

### Claim 14 (depends on 9, 10)

The composition of claim 9 or claim 10, comprising (b) EVs derived from a biologically pure strain of Intestinimonas massiliensis; and (d) EVs derived from a biologically pure strain of an Akkermansia sp., wherein said Akkermansia sp. is not (i) Akkermansia muciniphila; or (ii) Akkermansia glycaniphilia.

### Claim 15 (depends on 14)

The composition of claim 14, comprising (b) EVs derived from a bacterial strain having a 16S ribosomal RNA sequence displaying at least 97.0% sequence similarity to a 16S ribosomal RNA sequence of I. massiliensis deposited at DSM under number DSM 33460.

### Claim 16 (depends on 14, 15)

The composition of claim 14 or claim 15, wherein genome-wide average nucleotide identity (gANI) between said Akkermansia sp. and (i) Akkermansia muciniphila; or (ii) Akkermansia glycaniphilia is less than about 95%.

### Claim 17 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16)

The composition of any one of claims 14-16, comprising (b) EVs derived from the I. massiliensis strain deposited at DSM under number DSM 33460or a live strain having all of the identifying characteristics of the I. massiliensis strain deposited at DSM under number DSM 33460; and (d) EVs derived from the Akkermansia sp. deposited at DSM under number DSM 33459or a live strain having all of the identifying characteristics of the Akkermansia sp. deposited at DSM under number DSM 33459. The composition of any one of claims 1-16, wherein the composition is formulated for oral administration.

### Claim 18 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17)

The composition of any one of claims 1-17, wherein the composition is lyophilized or freeze dried.

### Claim 19 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18)

The composition of any one of claims 1-18, wherein the composition is encapsulated or coated.

### Claim 20 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19)

The composition of any one of claims 1-19, wherein the composition is a food product, food ingredient, dietary supplement, or medicament.

### Claim 21 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20)

The composition of any one of claims 1-20, wherein at least about 1×104 CFU/g composition to at least about 1×1012 CFU/g composition of bacteria is present in the composition.

### Claim 22 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21)

The composition of any one of claims 1-21, wherein the composition is a probiotic.

### Claim 23 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22)

The composition of any one of claims 1-22, wherein the composition has been pasteurized or heat treated.

### Claim 24 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23)

The composition of any one of claims 1-23, wherein the composition is a pharmaceutical composition and further comprises at least one pharmaceutically acceptable carrier and/or excipient.

### Claim 25 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24)

A tablet, prolonged-release capsule, prolonged-release granule, powder, sachet, or gummy comprising the composition of any one of claims 1-24.

### Claim 26 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25)

A kit comprising (a) (i) the composition of any one of claims 1-24; or (ii) the tablet, prolonged-release capsule, prolonged-release granule, powder, sachet, or gummy of claim 25 and b) written instructions for administration to a subject.

### Claim 27 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25)

A method for treating and/or preventing one or more obesity related disorders in a subject in need thereof, comprising administering a therapeutically effective amount of the composition of any one of claims 1-24 or the tablet, prolonged-release capsule, prolonged-release granule, powder, sachet, or gummy of claim 25 to the subject.

### Claim 28 (depends on 27)

The method of claim 27, wherein the obesity related disorder is one or more disorders selected from the group consisting of obesity, metabolic syndrome, diabetes mellitus, insulin deficiency-related disorders, insulin-resistance related disorders, glucose intolerance, abnormal lipid metabolism, non-alcoholic fatty liver disease, hepatic steatosis, leptin resistance, reduced resistin levels, and/or cardiovascular disease.

### Claim 29

A method for making a composition comprising combining a biologically pure strain of Intestinimonas massiliensis and a biologically pure strain of an Akkermansia sp., wherein said Akkermansia sp. is not (i) Akkermansia muciniphila; or (ii) Akkermansia glycaniphilia.

### Claim 30

A method for making a composition comprising deriving and combining extracellular vesicles (EVs) from a biologically pure strain of Intestinimonas massiliensis and a biologically pure strain of an Akkermansia sp. and wherein said Akkermansia sp. is not (i) Akkermansia muciniphila; or (ii) Akkermansia glycaniphilia

### Claim 31 (depends on 29, 30)

The method of claim 29 or claim 30, wherein the genome-wide average nucleotide identity (gANI) between said Akkermansia sp. and (i) Akkermansia muciniphila; or (ii) Akkermansia glycaniphilia is less than about 95%.

### Claim 32 (depends on 29, 30, 31)

The method of any one of claims 29-31, wherein the I. massiliensis comprises a 16S ribosomal RNA sequence displaying at least 97.0% sequence similarity to a 16S ribosomal RNA sequence of I. massiliensis deposited at DSM under number DSM 33460.

### Claim 33 (depends on 29, 30, 31, 32)

The method of any one of claims 29-32, wherein the I. massiliensis comprises the I. massiliensis strain deposited at DSM under number DSM 33460or a live strain having all of the identifying characteristics of the I. massiliensis strain deposited at DSM under number DSM 33460; and wherein the Akkermansia sp. comprises the Akkermansia sp. deposited at DSM under number DSM 33459or a live strain having all of the identifying characteristics of the Akkermansia sp. deposited at DSM under number DSM 33459.

### Claim 34 (depends on 29, 30, 31, 32, 33)

The method of any one of claims 29-33, further comprising freeze frying or lyophilizing the composition.

### Claim 35 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25)

A composition for use in the prevention and/or treatment of one or more obesity-related disorders in a subject in need thereof, comprising the composition of any one of claims 1-24 or the tablet, prolonged-release capsule, prolonged-release granule, powder, sachet, or gummy of claim 25 to the subject.

### Claim 36 (depends on 35)

The composition for use of claim 35, wherein the obesity related disorder is one or more disorders selected from the group consisting of obesity, metabolic syndrome, diabetes mellitus, insulin deficiency-related disorders, insulin-resistance related disorders, glucose intolerance, abnormal lipid metabolism, non-alcoholic fatty liver disease, hepatic steatosis, leptin resistance, reduced resistin levels, and/or cardiovascular disease.