IP Library Granted Patent US 10,583,158
Granted Patent B2
US 10,583,158 · App. 16/022,484 · Granted Mar 10, 2020

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 10,583,158
App. No.
16/022,484
Granted
Mar 10, 2020
Kind
B2
Abstract

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

Claims (18)

1. A method of reducing sulfide-reducing bacteria in a gastrointestinal tract of a subject, comprising administering to the subject a pharmaceutical composition that comprises: at least 1×10 3 CFU of a lyophilized bacteria strain of the species Blautia hydrogenotrophica ; wherein the bacteria strain comprises a polynucleotide sequence of a 16S rRNA gene that has at least 95% sequence identity to the polynucleotide sequence of SEQ ID NO:5, as determined by a Smith-Waterman homology search algorithm using an affine gap search with a gap open penalty of 12, a gap extension penalty of 2, and a Blocks Substitution Matrix (BLOSUM) of 62; and a pharmaceutically acceptable excipient, diluent, or carrier,

wherein an amount of the sulfide-reducing bacteria in the gastrointestinal tract of the subject is reduced relative to an amount of sulfide-reducing bacteria in the gastrointestinal tract of the subject prior to the administering, as determined by bacteria count in feces.

2. The method of claim 1 , wherein the administering results in at least a 1 log decrease in the sulfide-reducing bacteria relative to the amount of sulfide-reducing bacteria prior to the administering.

3. The method of claim 1 , wherein the subject has an elevated level of sulfide-reducing bacteria relative to a healthy subject, prior to the administering.

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

5. The method of claim 1 , wherein the pharmaceutical composition is suitable for oral administration.

6. The method of claim 1 , wherein the pharmaceutical composition is a solid pharmaceutical composition.

7. The method of claim 1 , wherein the bacteria strain is active.

8. The method of claim 6 , wherein the pharmaceutical composition is an enteric formulation.

9. The method of claim 1 , wherein the pharmaceutical composition is encapsulated in one or more capsules.

10. The method of claim 9 , wherein the one or more capsules are enteric capsules.

11. The method of claim 1 , wherein the pharmaceutical composition comprises an antioxidant.

12. The method of claim 1 , wherein the pharmaceutical composition comprises at least 1×10 9 CFU of the bacteria strain.

13. The method of claim 1 , wherein the pharmaceutical composition comprises from 1×10 3 CFU/g to about 1×10 11 CFU/g of the bacteria strain with respect to total weight of the pharmaceutical composition.

14. The method of claim 1 , wherein the administering comprises providing one or more doses of 1 g, 3 g, 5 g or 10 g of the pharmaceutical composition.

15. The method of claim 1 , wherein the subject has one or more of irritable bowel syndrome, Crohn's disease, ulcerative colitis, functional dyspepsia, or infantile colic.

16. The method of claim 1 , further comprising administering an additional therapeutic agent to the subject.

17. The method of claim 1 , wherein at least 50% of the bacteria strain as measured by an amount of CFU, remains viable after about 1 year of storage when the pharmaceutical composition is stored in a closed container at 25° C. at 95% relative humidity.

Assignments (4)
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 →
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 Jul 25, 2018
From: BERNALIER-DONADILLE, ANNICK; CROUZET, LAUREEN; HABOUZIT, CHLOE
To: 4D PHARMA PLC
Reel/Frame 046454/0453 →
Priority Claims (3)
GB 1603817.6 · Mar 4, 2016 · national
GB 1612191.5 · Jul 13, 2016 · national
GB 1616022.8 · Sep 20, 2016 · national
Continuity (3)
Continuation 15916202 · Mar 8, 2018
Continuation PCTEP2017025038 · Mar 6, 2017
Related Publication 20180369294A1 · Dec 27, 2018