IP Library Granted Patent US 10,898,526
Granted Patent B2
US 10,898,526 · App. 16/560,371 · Granted Jan 26, 2021

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 10,898,526
App. No.
16/560,371
Granted
Jan 26, 2021
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 stability of the microbiota of a subject.

Claims (14)

1. A method of inducing a temporal variation as determined by fecal sample analysis in the gastrointestinal flora microbiota of a subject having autism in need thereof, comprising administering to the subject a composition that comprises a therapeutically effective amount of a bacteria strain of Blautia hydrogenotrophica with 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, wherein the administering is effective to induce the temporal variation in the microbiota of the subject having the autism.

2. The method of claim 1 , wherein the subject has the autism and the administering induces a temporal increase of a bacteria from the genus Clostridium XIVa, of the species Bacteroides acidifaciens , of the species Alistipes finegoldii , from the genus Barnesiella , from the family Porphyromonadaceae, from the genus Alistipes , of the species Alistipes massiliensis , from the family Lachnospiraceae, from the family Erysipelotrichaceae, from the genus Clostridium IV, or of the species Clostridium lactatifermentans , or a temporal decrease of a bacteria of the species Eubacterium ventriosum , of the species Akkermansia muciniphila , or from the genus Blautia XIVa.

3. The method of claim 1 , wherein the bacteria strain is dried.

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

5. The method of claim 1 , wherein the therapeutically effective amount of the bacteria strain comprises at least 1×10 6 CFU/g of the bacteria strain with respect to the total weight of the composition.

6. The method of claim 1 , wherein the bacteria strain comprises a polynucleotide sequence of a 16S rRNA gene that has at least 99% 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.

7. The method of claim 1 , wherein the bacteria strain comprises the polynucleotide sequence of SEQ ID NO:5.

8. The method of claim 1 , wherein said administering comprises oral, rectal, nasal, buccal, sublingual, or subcutaneous administration.

9. The method of claim 1 , wherein the composition is formulated for delivery to an intestine of the subject.

10. The method of claim 1 , wherein the composition is encapsulated.

11. The method of claim 1 , wherein the composition comprises an enteric coating.

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

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

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

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 Sep 5, 2019
From: JEFFERY, IAN; SHANAHAN, FERGUS; O'TOOLE, PAUL; STEVENSON, ALEX; MULDER, IMKE; SAVIGNAC, HELENE
To: 4D PHARMA PLC
Reel/Frame 050279/0609 →
Priority Claims (1)
GB 1621123.7 · Dec 12, 2016 · national
Continuity (4)
Continuation 16147551 · Sep 28, 2018
Continuation 15915889 · Mar 8, 2018
Continuation PCTGB2017053722 · Dec 12, 2017
Related Publication 20200129567A1 · Apr 30, 2020