IP Library Granted Patent US 11,224,620
Granted Patent B2
US 11,224,620 · App. 16/743,212 · Granted Jan 18, 2022

Compositions comprising bacterial strains

Inventors: Annick Bernalier-Donadille (La Roche Blanc, FR); Laureen Crouzet (Beaumont, FR); Chloe Habouzit (Chamalieres, FR)
Assignee: 4D PHARMA PLC
A61K35/74A61K9/00A61K9/19A61K9/48A61K9/4891A61K35/741A61K47/02A61K47/10A61K47/12A61K47/26A61K47/36A61K47/38A61K47/42A61P1/00A61K2035/11A61K2035/115
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Quick Facts
Patent No.
US 11,224,620
App. No.
16/743,212
Granted
Jan 18, 2022
Kind
B2
Abstract

The invention provides compositions comprising one or more bacterial strains for treating or preventing visceral hypersensitivity.

Claims (17)

1. A pharmaceutical composition that comprises a therapeutically effective amount of a lyophilized bacteria strain of the species Blautia hydrogenotrophica to treat visceral hypersensitivity in a subject in need thereof, wherein the therapeutically effective amount comprises from 1×10 3 to 1×10 12 colony forming units (CFU)/g of the lyophilized bacteria strain, with respect to total weight of said pharmaceutical composition, wherein the bacteria strain comprises the 16s rRNA gene sequence set forth in SEQ ID NO: 5;

an oxygen scavenger that is vitamin C; a compound selected from the group consisting of inulin, transgalacto-oligosaccharides, fructo-oligosaccharides, isomalt-oligosaccharides, pectins, xylo-oligosaccharides, chitosan-oligosaccharides, beta-glucans, arable gum modified and resistant starches, polydextrose, D-tagatose, acacia fibers, carob, oats, citrus fibers, non-digestible carbohydrates, and sugar alcohols, or any combination thereof; and

a pharmaceutically acceptable excipient, diluent, or carrier;

wherein the therapeutically effective amount is sufficient to increase an amount of butyrate in the gastrointestinal tract of the subject relative to a corresponding amount of butyrate prior to the administration or to decrease an amount of a sulphide reducing bacteria in the gastrointestinal tract of the subject relative to a corresponding amount of the sulphide reducing bacteria prior administration; and

wherein said pharmaceutical composition is a solid enteric formulation and is encapsulated.

2. The pharmaceutical composition of claim 1 , wherein said bacteria strain colonizes an intestine of a subject when administered to said subject.

3. The pharmaceutical composition of claim 1 , wherein said pharmaceutical composition is formulated for oral or rectal delivery.

4. The pharmaceutical composition of claim 1 , wherein said bacteria strain is the bacteria strain deposited under accession number DSM 10507, DSM 14294, or a biotype thereof.

5. A method of treating visceral hypersensitivity in a subject in need thereof comprising administering to said subject a pharmaceutical composition that comprises a therapeutically effective amount of a lyophilized bacteria strain of the species Blautia hydrogenotrophica to treat visceral hypersensitivity in the subject, wherein the bacteria strain comprises the 16s rRNA gene sequence set forth in SEQ ID NO: 5; an oxygen scavenger that is vitamin C; a compound selected from the group consisting of inulin, transgalacto-oligosaccharides, fructo-oligosaccharides, isomalt-oligosaccharides, pectins, xylo-oligosaccharides, chitosan-oligosaccharides, beta-glucans, arable gum modified and resistant starches, polydextrose, D-tagatose, acacia fibers, carob, oats, citrus fibers, non-digestible carbohydrates, and sugar alcohols, or any combination thereof; and a pharmaceutically acceptable excipient, diluent, or carrier;

wherein said therapeutically effective amount comprises from 1×10 3 to 1×10 12 colony forming units (CFU) per gram of the lyophilized bacteria strain with respect to total weight of said pharmaceutical composition;

wherein said pharmaceutical composition is a solid enteric formulation and is encapsulated; and

wherein said therapeutically effective amount is sufficient to increase an amount of butyrate in the gastrointestinal tract of the subject relative to a corresponding amount of butyrate prior to the administration or to decrease an amount of a sulphide reducing bacteria in the gastrointestinal tract of the subject relative to a corresponding amount of the sulphide reducing bacteria prior administration.

6. The method of claim 5 , wherein said bacteria strain colonizes an intestine of said subject when administered to said subject.

7. The method of claim 5 , wherein said bacteria strain is the Blautia hydrogenotrophica bacteria strain deposited under accession number DSM 10507, DSM 14294, or a biotype thereof.

8. The method of claim 5 , wherein said administering comprises oral, rectal, nasal, buccal, sublingual, or subcutaneous administration.

9. The method of claim 5 , wherein said subject has irritable bowel syndrome.

10. The method of claim 5 , wherein said subject is a human.

Assignments (5)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 14, 2023
From: 4D PHARMA PLC; 4D PHARMA RESEARCH LIMITED
To: CJ BIOSCIENCE, INC.
Reel/Frame 063992/0427 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 31, 2022
From: OXFORD FINANCE LUXEMBOURG S.A R.L.
To: ARMISTICE CAPITAL MASTER FUND LTD.
Reel/Frame 061806/0371 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 3, 2021
From: BERNALIER-DONADILLE, ANNICK; CROUZET, LAUREEN; HABOUZIT, CHLOE
To: 4D PHARMA PLC
Reel/Frame 058281/0183 →
INTELECTUAL PROPERTY SECURITY AGREEMENT Recorded Jul 30, 2021
From: 4D PHARMA PLC; 4D PHARMA RESEARCH LIMITED; 4D PHARMA CORK LIMITED; 4D PHARMA DELAWARE INC.
To: OXFORD FINANCE LUXEMBOURG S.A R.L.
Reel/Frame 057042/0715 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 20, 2020
From: BERNALIER-DONADILLE, ANNICK; CROUZET, LAUREEN; HABOUZIT, CHLOE
To: 4D PHARMA PLC
Reel/Frame 054433/0562 →
Continuity (4)
Continuation 16022484 · Jun 28, 2018
Continuation 15916202 · Mar 8, 2018
Continuation PCTEP1017025038 · Mar 6, 2017
Related Publication 20200323927A1 · Oct 15, 2020