IP Library Granted Patent US 10,485,830
Granted Patent B2
US 10,485,830 · App. 16/022,256 · Granted Nov 26, 2019

Compositions comprising bacterial strains

Inventors: Ian Jeffery (Cork, IE); Fergus Shanahan (Kinsale, IE); Paul O'Toole (Cork, IE); Alex Stevenson (Leeds, GB); Imke Mulder (Aberdeen, GB); Helene Savignac (Leeds, GB)
Assignee: 4D PHARMA PLC
A61K35/74A61K9/19A61K9/48A61P1/00A61P1/14A61P29/00A61K2035/11
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Quick Facts
Patent No.
US 10,485,830
App. No.
16/022,256
Granted
Nov 26, 2019
Kind
B2
Abstract

Provided are compositions comprising a bacterial strain of the genus Blautia , for use in a method of increasing the microbiota diversity and/or inducing stability of the microbiota of a subject.

Claims (17)

1. A method comprising administering to a subject a pharmaceutical composition that comprises: a bacteria strain of the species Blautia hydrogenotrophica comprising 99.5% 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 the administering results in an increase in an amount of Oscillibacter valericigenes and Barnesiella intestinihominis and a decrease in an amount of a bacteria from the genus Lachnospiraceae in the gastrointestinal tract of the subject relative to an amount of the respective bacteria prior to the administering, as determined by bacteria count in feces.

2. The method of claim 1 , wherein the bacteria strain comprises a polynucleotide sequence of a 16S rRNA gene that has polynucleotide sequence of SEQ ID NO: 5.

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

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

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

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

7. The method of claim 1 , wherein the pharmaceutical composition is an enteric formulation.

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

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

10. The method of claim 1 , wherein the pharmaceutical composition comprises from about 1×10 9 to about 1×10 12 CFU of the bacteria strain.

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

12. 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.

13. The method of claim 1 , wherein the subject has less than 99 different bacterial species and/or less than 190 different bacterial strains in its microbiota.

14. The method of claim 1 , wherein the subject has less microbiotic diversity or stability relative to a healthy subject, as determined by a Shannon diversity index.

15. The method of claim 1 , wherein the subject has one or more of irritable bowel syndrome, irritable bowel disorder, obesity, or type 2 diabetes.

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 (3)
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 3, 2018
From: JEFFERY, IAN; SHANAHAN, FERGUS; O'TOOLE, PAUL; STEVENSON, ALEX; MULDER, IMKE; SAVIGNAC, HELENE
To: 4D PHARMA PLC
Reel/Frame 046263/0216 →
Priority Claims (1)
GB 1621123.7 · Dec 12, 2016 · national
Continuity (3)
Continuation 15915889
Continuation PCTGB2017053722 · Dec 12, 2017
Related Publication 20180369293A1 · Dec 27, 2018