Compositions comprising bacterial strains

Patent metadata

Field	Value
Publication number	US-2017143773-A1
Application number	US-201615357936-A
Country	US
Kind code	A1
Filing date	Nov 21, 2016
Priority date	Nov 20, 2015
Publication date	May 25, 2017
Grant date	—

Abstract

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

First claim

What is claimed is:

1 . A pharmaceutical composition comprising a therapeutically effective amount of a bacteria strain of the species Enterococcus faecium; wherein said therapeutically effective amount of said bacteria strain is an amount sufficient to produce a decrease in production of at least one cytokine in a subject; and wherein said bacterial strain is lyophilized and/or said pharmaceutical composition further comprises a pharmaceutically acceptable excipient, diluent, or carrier.

2 . The pharmaceutical composition of claim 1 , further comprising a lyoprotectant which is a pharmaceutically acceptable excipient, diluent, or carrier.

3 . The pharmaceutical composition of claim 1 , wherein the bacteria strain comprises a polynucleotide sequence that is a 16s rRNA sequence with at least 95% homology to the polynucleotide of SEQ ID NO:2.

4 . The pharmaceutical composition of claim 1 , comprising a bacteria strain that comprises a polynucleotide sequence that is the 16s rRNA sequence of SEQ ID NO:2.

5 . The pharmaceutical composition of claim 1 , said bacterial strain consisting essentially of Enterococcus faecium.

6 . The pharmaceutical composition of claim 1 , further comprising at least one additional bacteria strain.

7 . The pharmaceutical composition of claim 1 , wherein the at least one cytokine comprises an IL-17 cytokine selected from the group consisting of: IL-17A, IL-17B, IL-17C, IL-17D, IL-17E, and IL-17F.

8 . The pharmaceutical composition of claim 1 , wherein the therapeutically effective amount is an amount effective sufficient to treat or prevent a condition mediated by an increase in the at least one cytokine in the subject.

9 . The pharmaceutical composition 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.

10 . The pharmaceutical composition of claim 1 , wherein the therapeutically effective amount 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.

11 . The pharmaceutical composition of claim 1 , wherein the composition is a lyophilized composition.

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

13 . The pharmaceutical composition of claim 12 , further comprising an enteric coating.

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

15 . A vaccine comprising the pharmaceutical composition of claim 1 .

16 . A food product that comprises: a therapeutically effective amount of a bacteria strain of the species Enterococcus faecium; and a nutritious product.

17 . The food product of claim 16 , wherein the nutritious product is a milk-based product selected from the group consisting of: a cow's milk, a goat's milk, a sheep's milk, skimmed milk, whole milk, milk recombined from powdered milk, yogurt, curdled milk, curd, sour milk, sour whole milk, butter milk, a whey beverage, a fermented milk, a condensed milk, an infant milk, a flavored milk, and an ice cream.

18 . A method of treating or preventing a condition in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of a pharmaceutical composition comprising a bacteria strain of the species Enterococcus faecium; wherein said bacteria strain is present in an amount sufficient for treating or preventing a condition mediated by the Th17 pathway or by an increase in the IL-17 cytokine in the subject.

19 . The method of claim 18 , wherein the bacteria strain is lyophilized and/or the pharmaceutical composition further comprises a pharmaceutically acceptable excipient, diluent, or carrier.

20 . The method of claim 18 , wherein said IL-17 cytokine is selected from the group consisting of: IL-17A, IL-17B, IL-17C, IL-17D, IL-17E, and IL-17F.

21 . The method of claim 18 , wherein the condition mediated by the Th17 pathway or by an increase in the IL-17 cytokine is selected from the group consisting of: uveitis; a cancer;
multiple sclerosis; an arthritis; neuromyelitis optica; psoriasis; systemic lupus erythematosus; an inflammatory bowel disease; celiac disease; an asthma; allergic asthma; neutrophilic asthma; chronic obstructive pulmonary disease (COPD); scleritis; vasculitis; Behcet's disease; atherosclerosis; atopic dermatitis; emphysema; periodontitis; allergic rhinitis; and allograft rejection.

22 . The method of claim 21 , wherein the condition mediated by the Th17 pathway or by an increase in the IL-17 cytokine is a cancer, and wherein the cancer is breast cancer, lung cancer, liver cancer, colon cancer, or ovarian cancer.

23 . The method of claim 21 , wherein the condition mediated by the Th17 pathway or by an increase in the IL-17 cytokine is an arthritis, and wherein the arthritis is rheumatoid arthritis, osteoarthritis, psoriatic arthritis, spondyloarthritis, ankylosing spondylitis, or juvenile idiopathic arthritis.

24 . The method of claim 21 , wherein the condition mediated by the Th17 pathway or by an increase in the IL-17 cytokine is an inflammatory bowel disease, and wherein the inflammatory bowel disease is Crohn's disease or ulcerative colitis.

25 . The method of claim 18 , wherein the bacteria strain comprises a polynucleotide sequence that is the 16s rRNA sequence of SEQ ID NO:2.

26 . The method of claim 18 , wherein the subject has the condition, or has been identified as being at risk of the condition.

27 . The method of claim 18 , wherein the subject has previously received an anti-TNF-α therapy.

28 . The method of claim 18 , further comprising administering an additional therapeutic agent to the subject.

29 . The method of claim 18 , wherein the administering of the pharmaceutical composition comprises oral, rectal, nasal, buccal, sublingual, intraperitoneal, or subcutaneous administration.

30 . The method of claim 18 , wherein said administering comprises providing one or more doses of 1 g, 3 g, 5 g or 10 g of said pharmaceutical composition.

Assignees

• 4D Pharma Res Ltd

Inventors

• MULDER Imke Elisabeth
• HOLT Amy Beth
• Mccluskey Seanin Marie
• Lennon Grainne Clare
• Ahmed Suaad

Classifications

• A61P35/00

  Antineoplastic agents · CPC title

• A61P37/08

  Antiallergic agents (antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14) · CPC title

• A61P9/10

  for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis · CPC title

• A61P9/00

  Drugs for disorders of the cardiovascular system · CPC title

• A61P37/00

  Drugs for immunological or allergic disorders · CPC title