IP Library Granted Patent US 10,046,015
Granted Patent B2
US 10,046,015 · App. 15/357,936 · Granted Aug 14, 2018

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
A61K35/74A23C9/1585A23L33/135A61K9/0053A61K9/19A61K9/50A61K39/09A23V2002/00A61K2035/11A61K2039/52A61K2039/585
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Quick Facts
Patent No.
US 10,046,015
App. No.
15/357,936
Granted
Aug 14, 2018
Kind
B2
Abstract

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

Claims (23)

1. A method of reducing inflammation associated with Th17 differentiation in a subject with a condition mediated by the Th17 pathway, comprising administering orally to the subject a pharmaceutical composition that comprises an amount of a bacteria strain of the species Enterococcus faecium;

wherein said bacteria strain is live and lyophilized; and wherein said bacteria strain has an enzyme profile as determined by a Rapid ID 32A analysis that is:

(i) positive for at least one of: arginine dihydrolase, β-glucosidase, mannose fermentation, glutamic acid decarboxylase, arginine arylamidase, phenylalanine arylamidase, leucine arylamidase, pyroglutamic acid arylamidase, tyrosine arylamidase, glycine arylamidase, histidine arylamidase and serine arylamidase; and

(ii) intermediate for N-acetyl-β-glucosaminidase;

wherein said pharmaceutical composition does not comprise Bacillus subtilis or Bacillus coagulans;

and wherein said administering reduces inflammation associated with Th17 differentiation.

2. The method of claim 1 , wherein said administering decreases an amount of IL-17A, IL-17B, IL-17C, IL-17D, IL-17E, or IL-17F; relative to an amount prior to said administering.

3. The method of claim 1 , wherein the condition comprises uveitis; multiple sclerosis; arthritis; neuromyelitis optica; psoriasis; systemic lupus erythematosus; inflammatory bowel disease; celiac disease; asthma; allergic asthma; neutrophilic asthma; chronic obstructive pulmonary disease (COPD); scleritis; vasculitis; Behcet's disease; atherosclerosis; atopic dermatitis; emphysema; periodontitis; allergic rhinitis; or allograft rejection.

4. The method of claim 3 , wherein the condition is arthritis, and wherein the arthritis is rheumatoid arthritis, osteoarthritis, psoriatic arthritis, spondyloarthritis, ankylosing spondylitis, or juvenile idiopathic arthritis.

5. The method of claim 3 , wherein the condition is inflammatory bowel disease, and wherein the inflammatory bowel disease is Crohn's disease or ulcerative colitis.

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

7. The method of claim 1 , wherein the subject has the condition, or has been identified as being at risk of the condition.

8. The method of claim 1 , wherein the subject has previously received an anti-TNF-α therapy.

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

10. The method of claim 1 , wherein said administering comprises providing one or more doses of 1 g, 3 g, 5 g or 10 g of said pharmaceutical composition.

11. The method of claim 3 , wherein the condition is uveitis.

12. The method of claim 3 , wherein the condition is asthma.

13. A method of reducing inflammation associated with Th17 differentiation in a subject with a condition mediated by the Th17 pathway, comprising administering orally to the subject a pharmaceutical composition consisting essentially of an amount of a bacteria strain of the species Enterococcus faecium;

wherein said bacteria strain is live and lyophilized;

wherein said administering reduces inflammation associated with Th17 differentiation in uveitis, arthritis, or asthma.

14. The method of claim 1 or 13 , wherein the bacteria strain comprises a polynucleotide sequence that is a 16s rRNA gene sequence with at least 95% homology to the polynucleotide of SEQ ID NO:2 as determined by the Smith-Waterman homology search algorithm using an affine gap search with a gap open penalty of 12 and a gap extension penalty of 2, and a BLOSUM matrix of 62.

15. The method of claim 1 or 13 , wherein said bacteria strain is the bacteria strain of the species Enterococcus faecium deposited under accession number NCIMB 42487.

16. The method of claim 1 or 13 , wherein said pharmaceutical composition comprises from about 1×10 6 to about 1×10 11 CFU/g of said bacteria strain with respect to a total weight of the pharmaceutical composition.

Assignments (6)
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 Jun 7, 2017
From: LENNON, GRAINNE CLARE
To: 4D PHARMA RESEARCH LIMITED
Reel/Frame 042623/0960 →
CORRECTIVE ASSIGNMENT TO CORRECT THE CITY AND COUNTRY OF THE ASSIGNEE PREVIOUSLY RECORDED ON REEL 041443 FRAME 0617. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT. Recorded Apr 7, 2017
From: AHMED, SUAAD; HOLT, AMY BETH; MULDER, IMKE ELISABETH; MCCLUSKEY, SEANIN MARIE
To: 4D PHARMA RESEARCH LIMITED
Reel/Frame 042190/0155 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 2, 2017
From: AHMED, SUAAD; HOLT, AMY BETH; MULDER, IMKE ELISABETH; MCCLUSKEY, SEANIN MARIE
To: 4D PHARMA RESEARCH LIMITED
Reel/Frame 041443/0617 →
Priority Claims (1)
GB 1520497.7 · Nov 20, 2015 · national
Continuity (1)
Related Publication 20170143773A1 · May 25, 2017