Bacterium for use as a probiotic for nutritional and medical applications

• US 9,314,489 B2
• Filed: 10/08/2012
• Issued: 04/19/2016
• 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:
  US14/349,907
• Publication Number:
  US 20150132264A1
• Time in Patent Office: 1,289 Days
• Field of Search: None
• US Class Current: 1/1
• 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 method of treating a disorder selected from an immune disorder, an inflammatory disorder and an intestinal disorder in a subject, said method comprising administering to the subject a pharmaceutically effective amount of the bacterial species Roseburia hominis.

2. The method of claim 1, wherein the disorder is selected from irritable bowel syndrome (IBS), colitis, inflammatory bowel disorder (IBD), pouchitis, functional dyspepsia, functional constipation, functional diarrhoea, functional abdominal pain, functional bloating, Epigastric Pain Syndrome, Postprandial Distress Syndrome, gastrointestinal reflux disease (GERD), autoimmune diseases, allergies, coeliac disease, atopic diseases, rhinitis, necrotising enterocolitis, and combinations thereof.

3. The method of claim 1, said method comprising administering to the subject a pharmaceutical composition comprising the bacterial species Roseburia hominis and a pharmaceutically acceptable excipient, carrier or diluent.

4. The method of claim 1, said method comprising administering to the subject a nutritional supplement comprising the bacterial species Roseburia hominis and a nutritionally acceptable excipient, carrier or diluent.

5. The method of claim 1, said method comprising administering to the subject a probiotic composition comprising the bacterial species Roseburia hominis.

6. The method of claim 1, said method comprising administering to the subject a feedstuff, food product, dietary supplement, nutritional supplement or food additive comprising the bacterial species Roseburia hominis.

7. The method of claim 1, wherein the inflammatory bowel disorder is selected from Crohn'"'"'s disease and ulcerative colitis.

8. The method of claim 2, wherein the functional diarrhoea is selected from the group consisting of antibiotic associated diarrhoea, traveller'"'"'s diarrhoea and pediatric diarrhoea.

9. The method of claim 2, wherein the autoimmune disease is selected from the group consisting of diabetes, arthritis, multiple sclerosis and psoriasis.

10. The method of claim 2, wherein the atopic disease is atopic dermatitis.