IP Library Granted Patent US 10,744,166
Granted Patent B2
US 10,744,166 · App. 15/969,543 · Granted Aug 18, 2020

Compositions comprising bacterial strains

Inventors: Imke Elisabeth Mulder (Aberdeen, GB); Amy Beth Holt (Aberdeen, GB); Seanin Marie McCluskey (Aberdeen, GB); Grainne Clare Lennon (Aberdeen, GB); Suaad Ahmed (Aberdeen, GB)
Assignee: 4D Pharma Research Limited
A61K35/74A23C9/152A23L33/135A61K9/19A61K31/00A61K39/08A61K39/39A23V2002/00A61K2035/11A61K2039/542A61K2039/55594A61K2039/577A61K2039/58
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Quick Facts
Patent No.
US 10,744,166
App. No.
15/969,543
Granted
Aug 18, 2020
Kind
B2
Abstract

The invention provides compositions comprising bacterial strains for treating and preventing inflammatory and autoimmune diseases.

Claims (21)

1. A pharmaceutical composition that comprises:

from about 1×10 3 to about 1×10 11 colony forming units (CFU)/g of a single therapeutically active bacterial strain, with respect to a total weight of said pharmaceutical composition, wherein said single therapeutically active bacterial strain is a bacterial strain of the species Erysipelatoclostridium ramosum , wherein the single therapeutically active bacterial strain is a spore-forming bacterial strain, and wherein said single therapeutically active bacterial strain is lyophilized; and

a pharmaceutically acceptable excipient, diluent, or carrier.

2. The pharmaceutical composition of claim 1 , wherein said pharmaceutically acceptable excipient, diluent, or carrier comprises a lyoprotectant.

3. The pharmaceutical composition of claim 1 , wherein said pharmaceutical composition comprises from about 1×10 6 to about 1×10 11 colony forming units (CFU)/g of said single therapeutically active bacteria strain with respect to said total weight of said pharmaceutical composition.

4. The pharmaceutical composition of claim 1 , wherein said pharmaceutical composition is an oral formulation.

5. The pharmaceutical composition of claim 4 , wherein said pharmaceutical composition is a solid pharmaceutical composition.

6. The pharmaceutical composition of claim 1 , wherein said pharmaceutical composition is in the form of a tablet or a capsule.

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

8. The pharmaceutical composition of claim 1 , wherein said pharmaceutical composition further comprises a prebiotic compound selected from the group consisting of: a fructo-oligosaccharide, a short-chain fructo-oligosaccharide, inulin, an isomalt-oligosaccharide, a transgalacto-oligosaccharide, a pectin, a xylo-oligosaccharide, a chitosan-oligosaccharide, a beta-glucan, and arable gum modified starch, a polydextrose, a D-tagatose, an acacia fiber, a carob, an oat, and a citrus fiber.

9. The pharmaceutical composition of claim 1 , wherein at least 50% of said single therapeutically active bacteria strain as measured by an amount of colony forming units (CFU) remains viable after about 1 year of storage when said pharmaceutical composition is stored in a closed container at 25° C. at 95% relative humidity.

10. A method of treating inflammation characterized by an elevated level of an IL-17 cytokine in a subject in need thereof, comprising administering to said subject a pharmaceutical composition that comprises: a therapeutically effective amount of a therapeutically active bacterial strain, wherein said therapeutically effective bacterial strain is a bacterial strain of the species Erysipelatoclostridium ramosum , and a pharmaceutically acceptable excipient, diluent, or carrier,

wherein said therapeutically active bacterial strain is a spore-forming bacterial strain, wherein said therapeutically active bacterial strain is lyophilized; and

wherein said administering is sufficient to reduce said elevated level of said IL-17 cytokine relative to a level of said IL-17 cytokine prior to said administering, thereby treating said inflammation.

11. The method of claim 10 , wherein said inflammation is associated with uveitis, and wherein said treating comprises reducing retinal damage in uveitis.

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

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

14. The method of claim 10 , wherein said administering is oral.

15. The method of claim 10 , wherein said pharmaceutical composition is a solid pharmaceutical composition.

16. The method of claim 10 , wherein said pharmaceutical composition is in the form of a tablet or a capsule.

17. The method of claim 10 , wherein said pharmaceutical composition is an enteric formulation.

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 Mar 7, 2019
From: MULDER, IMKE ELISABETH; HOLT, AMY BETH; MCCLUSKEY, SEANIN MARIE; LENNON, GRAINNE CLARE; AHMED, SUAAD
To: 4D PHARMA RESEARCH LIMITED
Reel/Frame 048526/0542 →
Priority Claims (1)
GB 1520631.1 · Nov 23, 2015 · national
Continuity (2)
Continuation 15359988 · Nov 23, 2016
Related Publication 20180250346A1 · Sep 6, 2018