IP Library Granted Patent US 10,080,772
Granted Patent B2
US 10,080,772 · App. 15/916,205 · Granted Sep 25, 2018

Compositions comprising bacterial strains

Inventors: Laureen Crouzet (Beaumont, FR); Chloe Habouzit (Chamaliere, FR); Annick Bernalier-Donadille (La Roche Blanc, FR)
Assignee: 4D Pharma PLC
A61K35/74A61K9/0053A61K9/19A61K9/48A61P31/04
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Quick Facts
Patent No.
US 10,080,772
App. No.
15/916,205
Granted
Sep 25, 2018
Kind
B2
Abstract

The invention provides compositions comprising one or more bacterial strains for use in a method of reducing the level of Enterobacteriaceae in the gastrointestinal tract.

Claims (14)

1. A method of reducing an amount of Escherichia coli ( E. coli ) in a gastrointestinal tract of a subject having an elevated level of E. coli , comprising administering to the subject a pharmaceutical composition comprising:

an active bacteria strain of Blautia hydrogenotrophica in an amount sufficient to reduce the amount of E. coli in the gastrointestinal tract of the subject relative to a corresponding amount of E. coli prior to the administering; and a pharmaceutically acceptable excipient, diluent, or carrier;

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

wherein the level of E. coli in the gastrointestinal tract of the subject is elevated prior to the administering as compared to the level of E. coli in the gastrointestinal tract of the subject after the administering.

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

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

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

5. The method of claim 4 , wherein the pharmaceutical composition is enterically coated.

6. 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 total weight of the pharmaceutical composition.

7. The method of claim 1 , wherein the pharmaceutical composition comprises a single bacteria strain of Blautia hydrogenotrophica.

8. The method of claim 1 , wherein the pharmaceutical composition comprises an amount of the bacteria strain sufficient to reduce an amount of hydrogen in the breath of the subject relative to a corresponding amount of hydrogen prior the administering, as determined by an administration of lactulose followed by a hydrogen breath analysis.

9. 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.

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

11. The method of claim 1 , wherein at least 50% of the bacteria strain as measured by an amount of colony forming units (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 May 3, 2018
From: CROUZET, LAUREEN; HABOUZIT, CHLOE; BERNALIER-DONADILLE, ANNICK
To: 4D PHARMA PLC
Reel/Frame 045703/0239 →
Priority Claims (5)
GB 1612190.7 · Jul 13, 2016 · national
GB 1616016.0 · Sep 20, 2016 · national
GB 1616018.6 · Sep 20, 2016 · national
GB 1703548.6 · Mar 6, 2017 · national
GB 1703552.8 · Mar 6, 2017 · national
Continuity (2)
Continuation PCTGB2017052076 · Jul 13, 2017
Related Publication 20180200307A1 · Jul 19, 2018