IP Library Granted Patent US 10,086,021
Granted Patent B2
US 10,086,021 · App. 15/915,889 · Granted Oct 2, 2018

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
A61K35/74A61K9/19A61K9/48A61P1/00A61K2035/11
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Quick Facts
Patent No.
US 10,086,021
App. No.
15/915,889
Granted
Oct 2, 2018
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 (19)

1. A method of increasing microbiotic diversity or maintaining microbiotic stability in a gastrointestinal tract of a subject in need thereof, comprising administering to the subject a pharmaceutical composition that comprises an effective amount of a bacteria strain of the species Blautia hydrogenotrophica sufficient for increasing microbiotic diversity or maintaining microbiotic stability in the gastrointestinal tract of the subject relative to an amount of microbiotic diversity or microbiotic stability prior to the administering,

wherein the bacteria strain comprises a 16s rRNA gene sequence of SEQ ID NO:5, and

wherein the administering results in an increase in an amount of a bacteria from at least one genus selected from Clostridium, Bifidobacterium , and Prevotella in the gastrointestinal tract of the subject relative to an amount of the respective bacteria prior to the administering.

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

3. The method of claim 1 , wherein the bacteria strain is encapsulated in one or more capsules.

4. The method of claim 1 , wherein the pharmaceutical composition comprises a pharmaceutically acceptable excipient, diluent, or carrier.

5. The method of claim 1 , wherein the bacteria strain is lyophilized.

6. The method of claim 1 , wherein the pharmaceutical composition is formulated for oral delivery.

7. The method of claim 6 , wherein the pharmaceutical composition is enterically formulated.

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

9. The method of claim 1 , wherein the method is a method of increasing microbiotic diversity.

10. The method of claim 9 , wherein prior to the administering the subject has a reduced microbiotic diversity relative to a healthy subject.

11. The method of claim 10 , wherein the subject has less than 99 different bacterial species or less than 190 different bacterial strains in its microbiota.

12. The method of claim 1 , wherein the method is a method of maintaining microbiotic stability.

13. The method of claim 10 , wherein the administering is sufficient to treat a disease or disorder associated with the reduced microbiotic stability in the subject.

14. The method of claim 1 , wherein the increasing microbiotic diversity or maintaining microbiotic stability is for non-acetogenic bacteria, or both acetogenic and non-acetogenic bacteria.

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

16. 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.

17. The method of claim 1 , wherein the amount of the bacteria from at least one genus selected from Clostridium, Bifidobacterium , and Prevotella is determined by measuring an amount of the respective bacteria in feces.

Assignments (4)
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 Apr 4, 2018
From: STEVENSON, ALEX; SAVIGNAC, HELENE; MULDER, IMKE
To: 4D PHARMA PLC
Reel/Frame 045436/0358 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 29, 2018
From: JEFFERY, IAN; SHANAHAN, FERGUS; O'TOOLE, PAUL
To: 4D PHARMA PLC
Reel/Frame 045382/0833 →
Priority Claims (1)
GB 1621123.7 · Dec 12, 2017 · national
Continuity (2)
Continuation PCTGB2017053722 · Dec 12, 2017
Related Publication 20180207208A1 · Jul 26, 2018