IP Library Granted Patent US 11,013,773
Granted Patent B2
US 11,013,773 · App. 16/206,250 · Granted May 25, 2021

Lactic acid bacterial strains

Inventor: Denise Kelly (Aberdeen, GB)
Assignee: 4D Pharma Research Limited
A61K35/747A23K10/18A23L33/135C12N1/20C12R1/225C12R1/23C12R1/25A23V2002/00Y02A50/30
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Quick Facts
Patent No.
US 11,013,773
App. No.
16/206,250
Granted
May 25, 2021
Kind
B2
Abstract

A first aspect of the invention relates to a porcine lactic acid bacterial strain, wherein said bacterial strain is characterised by one or more of the following characteristics: (i) the ability to exhibit antimicrobial activity against E. coli ; (ii) the ability to exhibit antimicrobial activity against S. enteritidis ; (iii) the ability to suppress inflammation in IPEC cells induced by 12-0-tetradecaboylphorbol-13-acetate (PMA); (iv) the ability to block the attachment or invasion of IPEC cells by S. enteritidis ; (v) the ability to block the attachment or invasion of IPEC cells by E. coli ; (vi) the absence of antibiotic resistance to one or more antibiotics selected from the following: ampicillin; cefotaxime; chloramphenicol; erythromycin; gentamicin; tetracycline; vancomycin; metronizadole; nalidixic acid; and kanamycin; and (vii) the ability to exhibit heat stability when subjected to three cycles of heating, each cycle comprising heating at a temperature of 70° C. for a period of 15 minutes. Further aspects of the invention relate to compositions comprising said bacterial strains, and therapeutic uses of said bacterial strains.

Claims (31)

1. A solid pharmaceutical composition that comprises at least 10 3 colony forming units (CFU) of at least one Lactobacillus bacteria strain, and a pharmaceutically acceptable excipient, diluent, or carrier,

wherein the at least one Lactobacillus bacteria strain comprises a polynucleotide of a 16S rRNA gene having at least 95% identity to the polynucleotide of SEQ ID NO: 41, as determined by sequence alignment performed using BLAST, and

wherein the solid pharmaceutical composition is a formulation in unit dose form.

2. The solid pharmaceutical composition of claim 1 , wherein the solid pharmaceutical composition is lyophilized.

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

4. The solid pharmaceutical composition of claim 1 , wherein the solid pharmaceutical composition further comprises a preservative or stabilizer.

5. The solid pharmaceutical composition of claim 1 , wherein the solid pharmaceutical composition comprises from about 10 3 to about 10 11 colony forming units (CFU) of the at least one Lactobacillus bacteria strain per gram of the solid pharmaceutical composition.

6. The solid pharmaceutical composition of claim 1 , wherein the at least one Lactobacillus bacteria strain exhibits at least one characteristic selected from the group consisting of:

(i) antimicrobial activity against E. coli;

(ii) antimicrobial activity against S. enteritidis;

(iii) suppression of inflammation in intestinal pig epithelial cells (IPEC) induced by 12-0-tetradecaboylphorbol-13-acetate (PMA);

(iv) an ability to block the adherence or invasion of the IPEC by S. enteritidis;

(v) an ability to block the adherence or invasion of the IPEC by E. coli ; and

(vi) absence of antibiotic resistance to an antibiotic selected from the group consisting of: ampicillin; cefotaxime; chloramphenicol; erythromycin; gentamicin; tetracycline; vancomycin; metronizadole; nalidixic acid; and kanamycin.

7. The solid pharmaceutical composition of claim 1 , wherein the at least one Lactobacillus bacteria strain exhibits at least two characteristics selected from the group of claim 6 .

8. The solid pharmaceutical composition of claim 1 , wherein the at least one Lactobacillus bacteria strain exhibits at least three characteristics selected from the group of claim 6 .

9. The solid pharmaceutical composition of claim 1 , wherein the at least one Lactobacillus bacteria strain exhibits at least four characteristics selected from the group of claim 6 .

10. The solid pharmaceutical composition of claim 1 , wherein the at least one Lactobacillus bacteria strain is of a species selected from the group consisting of Lactobacillus johnsonii, Lactobacillus reuteri, Lactobacillus plantarum, Lactobacillus paraplantarum, Lactobacillus gasseri, Lactobacillus pentosus, Lactobacillus helveticus, Lactobacillus acidophilus, Lactobacillus vaginalis, Lactobacillus mucosae , and any combination thereof.

11. A solid pharmaceutical composition that comprises:

at least 10 3 colony forming units (CFU) of at least one bacteria strain of a species selected from the group consisting of Lactobacillus paraplantarum, Lactobacillus pentosus, Lactobacillus helveticus , and any combination thereof; and

a pharmaceutically acceptable excipient, diluent, or carrier, wherein the solid pharmaceutical composition is a formulation in unit dose form.

12. The solid pharmaceutical composition of claim 11 , wherein the solid pharmaceutical composition is lyophilized.

13. The solid pharmaceutical composition of claim 11 , wherein the solid pharmaceutical composition is encapsulated in one or more capsules.

14. The solid pharmaceutical composition of claim 11 , wherein the solid pharmaceutical composition further comprises a preservative or stabilizer.

15. The solid pharmaceutical composition of claim 11 , wherein the solid pharmaceutical composition comprises from about 10 3 to about 10 11 colony forming units (CFU) of the at least one bacteria strain per gram of the solid pharmaceutical composition.

16. A method of treating an intestinal disorder in a subject, the method comprising administering to the subject a solid pharmaceutical composition that comprises at least 10 3 colony forming units (CFU) of at least one Lactobacillus bacteria strain, and a pharmaceutically acceptable excipient, diluent, or carrier,

wherein the at least one Lactobacillus bacteria strain comprises a polynucleotide of a 16S rRNA gene having at least 95% identity to the polynucleotide of SEQ ID NO: 41, as determined by sequence alignment performed using BLAST, and wherein the solid pharmaceutical composition is a formulation in unit dose form.

17. The method of claim 16 , wherein the intestinal disorder is selected from the group consisting of salmonellosis , irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), functional dyspepsia, functional constipation, functional diarrhea, functional abdominal pain, functional bloating, Epigastric Pain Syndrome, Postprandial Distress Syndrome, Crohn's disease, ulcerative colitis, gastroesophageal reflux disease (GERD), necrotizing enterocolitis, and any combination thereof.

18. The method of claim 16 , wherein the at least one Lactobacillus bacteria strain is of a species selected from the group consisting of Lactobacillus johnsonii, Lactobacillus reuteri, Lactobacillus plantarum, Lactobacillus paraplantarum, Lactobacillus gasseri, Lactobacillus pentosus, Lactobacillus helveticus, Lactobacillus acidophilus, Lactobacillus vaginalis, Lactobacillus mucosae , and any combination thereof.

19. The method of claim 16 , wherein the administering is oral.

20. The method of claim 16 , wherein the subject is human.

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 →
CHANGE OF NAME Recorded Jul 30, 2019
From: GT BIOLOGICS LIMITED
To: 4D PHARMA RESEARCH LIMITED
Reel/Frame 049896/0994 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 30, 2019
From: KELLY, DENISE
To: GT BIOLOGICS LIMITED
Reel/Frame 049898/0672 →
Priority Claims (1)
GB 1112091 · Jul 14, 2011 · national
Continuity (3)
Continuation 15359144 · Nov 22, 2016
Division 14232475
Related Publication 20190216865A1 · Jul 18, 2019