Composition of Roseburia hominis

• US 9,937,211 B2
• Filed: 03/15/2016
• Issued: 04/10/2018
• Est. Priority Date: 10/07/2011
• Status: Active Grant

• Current Assignee: Armistice Capital Master Fund Ltd. (Armistice Capital LLC), CJ Bioscience Incorporated
• Original Assignee: 4D Pharma Research Limited (4D Pharma PLC)
• Inventors: Kelly, Denise, Mulder, Imke
• Primary Examiner(s): Gitomer, Ralph J
• Application Number:
  US15/070,605
• Publication Number:
  US 20160279177A1
• Time in Patent Office: 756 Days
• Field of Search: None
• CPC Class Codes: A23K 10/18 of live microorganisms
• CPC Class Codes: A23L 33/135 Bacteria or derivatives thereof, e.g. probiotics
• CPC Class Codes: A23V 2002/00 Food compositions, function of food ingredients or processes for food or foodstuffs
• CPC Class Codes: A61K 2035/115 Probiotics
• CPC Class Codes: A61K 35/74 Bacteria therapeutic use of a bacterial protein A61K38/00
• CPC Class Codes: A61K 35/741 Probiotics probiotic yeast, e.g. saccharomyces A61K36/06
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 9/0053 Mouth and digestive tract, i.e. intraoral and peroral administration rectal administration A61K9/0031
• CPC Class Codes: A61P 1/00 Drugs for disorders of the alimentary tract or the digestive system
• CPC Class Codes: A61P 1/04 for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
• CPC Class Codes: A61P 1/10 Laxatives
• CPC Class Codes: A61P 1/12 Antidiarrhoeals
• CPC Class Codes: A61P 1/14 Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents
• CPC Class Codes: A61P 11/02 Nasal agents, e.g. decongestants
• CPC Class Codes: A61P 17/00 Drugs for dermatological disorders
• CPC Class Codes: A61P 17/04 Antipruritics
• CPC Class Codes: A61P 17/06 Antipsoriatics
• CPC Class Codes: A61P 19/02 for joint disorders, e.g. arthritis, arthrosis
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 3/02 : Nutrients, e.g. vitamins, minerals
• CPC Class Codes: A61P 3/10 : for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: A61P 31/00 : Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
• CPC Class Codes: A61P 37/00 : Drugs for immunological or allergic disorders
• CPC Class Codes: A61P 37/02 : Immunomodulators
• CPC Class Codes: A61P 37/06 : Immunosuppressants, e.g. drugs for graft rejection
• CPC Class Codes: A61P 37/08 : Antiallergic agents antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14
• CPC Class Codes: C12N 1/20 : Bacteria; Culture media therefor
• CPC Class Codes: Y02A 50/30 : Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

A first aspect of the invention relates to the bacterial species Roseburia hominis for use in: regulating the immune system of a subject treating an immune disorder; treating an intestinal disorder; improving intestinal microbiota; regulating the innate immune system of a subject; regulating the adaptive immune system of a subject; regulating appetite in a subject; promoting Tregs and immune tolerance; promoting gut health in a subject; and/or maintaining immune homeostasis in a subject. Further aspects of the invention relate to compositions comprising Roseburia hominis.

Claims

1. A pharmaceutical composition that comprises:

the bacteria species Roseburia hominis; and

a pharmaceutically acceptable excipient, carrier or diluent;

wherein the bacteria species is present in an amount sufficient to treat a disorder when administered to a subject in need thereof;

wherein the bacteria strain is lyophilized; and

wherein at least 1×

10³ colony forming units of the lyophilized bacteria are provided in one or more doses.

2. The pharmaceutical composition of claim 1, wherein the disorder is an inflammatory disorder, an immune disorder, or an intestinal disorder.

4. The pharmaceutical composition according to claim 1, wherein the disorder is selected from the group consisting of irritable bowel syndrome (IBS), colitis, inflammatory bowel disorder (IBD), pouchitis, functional dyspepsia, functional constipation, functional diarrhea, antibiotic associated diarrhoea, traveler'"'"'s diarrhea, pediatric diarrhea, functional abdominal pain, functional bloating, Epigastric Pain Syndrome, Postprandial Distress Syndrome, gastroesophageal reflux disease (GERD), autoimmune diseases, diabetes, arthritis, multiple sclerosis, psoriasis, allergies, coeliac disease, atopic diseases, atopic dermatitis, rhinitis, necrotising enterocolitis and combinations thereof.

5. The pharmaceutical composition of claim 1, wherein the pharmaceutical composition comprises a pharmaceutically acceptable carrier, wherein the pharmaceutically acceptable carrier is selected from the group consisting of lactose, starch, glucose, methyl cellulose, magnesium stearate, mannitol, sorbitol, and combinations thereof.

6. The pharmaceutical composition of claim 1, wherein the pharmaceutical composition comprises a pharmaceutically acceptable diluent, wherein the pharmaceutically acceptable diluent is selected from the group consisting of ethanol, glycerol, water and combinations thereof.

7. The pharmaceutical composition of claim 1, wherein the pharmaceutical composition is an edible composition.

8. The pharmaceutical composition of claim 1, wherein the pharmaceutical composition is a probiotic composition.

9. The pharmaceutical composition of claim 8, wherein the pharmaceutical composition further comprises a prebiotic compound.

10. The pharmaceutical composition of claim 9, wherein the prebiotic compound is a carbohydrate, inulin or a transgalacto-oligosaccharide.

11. The pharmaceutical composition of claim 10, wherein the pharmaceutical composition comprises the carbohydrate, and wherein the carbohydrate is selected from the group consisting of:

fructo-oligosaccharides;

short-chain fructo-oligosaccharides;

isomalt-oligosaccharides;

pectins, xylooligosaccharides;

chitosan-oligosaccharides;

beta-glucans;

arable gum modified and resistant starches;

polydextrose;

D-tagatose;

acacia fibers;

carob;

oats; and

citrus fibers.

12. The pharmaceutical composition of claim 9, wherein the prebiotic compound is in an amount of from about 1% to about 20% by weight with respect to a total weight of the composition.

13. The pharmaceutical composition of claim 1, wherein the administration is selected from the group consisting of oral, rectal, vaginal, parenteral, intramuscular, intraperitoneal, intraarterial, intrathecal, intrabronchial, subcutaneous, intradermal, intravenous, nasal, buccal, and sublingual.

14. The pharmaceutical composition of claim 1, wherein the amount of the bacteria species is from about 1×

10⁶ to about 1×

10¹¹ colony forming units per gram with respect to a weight of the composition.

15. The pharmaceutical composition of claim 1, wherein the composition is administered at a dose of 1 g, 3 g, 5 g or 10 g.

16. The pharmaceutical composition of claim 1, wherein the pharmaceutical composition further comprises at least one additional bacterium.

17. The pharmaceutical composition of claim 16, wherein the at least one additional bacterium is a food grade bacterium.

18. The pharmaceutical composition of claim 17, wherein the food grade bacterium is selected from the group consisting of lactic acid bacteria, bifidobacteria, propionibacteria, and mixtures thereof.

19. The pharmaceutical composition of claim 1, wherein the pharmaceutical composition is in the form of a suppository, a pessary, a suspension, an emulsion, a lotion, an ointment, a cream, a gel, a spray, a solution or a dusting powder.

20. The pharmaceutical composition of claim 1, wherein the bacteria species comprises a bacteria strain that has a DNA-DNA identify of at least 70% with a strain deposited under accession number NCIMB 14029, as measured by a sequence alignment performed using BLAST.

21. The pharmaceutical composition of claim 1, wherein the bacteria species comprises a bacteria strain that has a 16S rRNA identity of at least 99.5% with the strain deposited under accession number NCIMB 14029, as measured by a sequence alignment performed using BLAST.

22. The pharmaceutical composition of claim 1, wherein the bacteria species comprises the bacteria strain deposited under accession number NCIMB 14029.

3. A method of making a pharmaceutical composition that comprises the bacteria species Roseburia hominis, the method comprising:

growing a population of bacteria species Roseburia hominis in a culture media under anaerobic conditions comprising a mixture of N₂, CO₂ and H₂;

lyophilizing the population of the bacteria species to obtain at least 1×

10³ colony forming units of lyophilized bacteria; and

admixing the lyophilized bacteria with a pharmaceutically acceptable excipient, carrier or diluent.