IP Library Patent Application 16692734
Patent Application
App. No. 16/692,734

COMPOSITIONS COMPRISING BACTERIAL STRAINS

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Quick Facts
Patent No.
US None
App. No.
16/692,734
Abstract

The invention provides compositions comprising bacterial strains for treating and preventing central nervous system disorders and conditions.

Claims (36)

1 .- 32 . (canceled)

33 . A method of treating a neurodevelopmental disorder or a neuropsychiatric condition in a subject in need thereof, comprising administering to the subject a pharmaceutical composition that comprises a therapeutically effective amount of a bacteria strain of the species Enterococcus faecium, wherein the Enterococcus faecium bacteria strain comprises a polynucleotide sequence of a 16S rRNA gene that has at least 95% sequence identity to the polynucleotide sequence of SEQ ID NO:2, as determined by a Smith-Waterman homology search algorithm using an affine gap search with a gap open penalty of 12, a gap extension penalty of 2, and a Blocks Substitution Matrix (BLOSUM) of 62, and wherein the administering treats the neurodevelopmental disorder or the neuropsychiatric condition in the subject.

34 . The method of claim 33 , wherein the therapeutically effective amount of the Enterococcus faecium bacteria strain comprises at least 1×10 3 CFU/g of the Enterococcus faecium bacteria strain with respect to a total weight of the pharmaceutical composition.

35 . The method of claim 33 , wherein the therapeutically effective amount of the Enterococcus faecium bacteria strain comprises from about 1×10 6 to about 1×10 11 CFU/g of the Enterococcus faecium bacteria strain with respect to a total weight of the pharmaceutical composition.

36 . The method of claim 33 , wherein the pharmaceutical composition only contains the Enterococcus faecium bacteria strain.

37 . The method of claim 33 , wherein the subject has the neurodevelopmental disorder, and wherein the neurodevelopmental disorder is an autism spectrum disorder (ASD) or a child developmental disorder.

38 . The method of claim 37 , wherein the subject has the ASD, and wherein the ASD is autism or Asperger Syndrome.

39 . The method of claim 33 , wherein the subject has the neuropsychiatric condition, and wherein the neuropsychiatric condition is selected from the group consisting of obsessive compulsive disorder (OCD), major depressive disorder, seasonal affective disorder, an anxiety disorder, chronic fatigue syndrome, post-traumatic stress disorder, a schizophrenia spectrum disorder, bipolar disorder, psychosis, and mood disorder.

40 . The method of claim 39 , wherein the subject has the schizophrenia spectrum disorder, and wherein the schizophrenia spectrum disorder is schizophrenia.

41 . The method of claim 39 , wherein the subject has the major anxiety disorder, and wherein the major anxiety disorder is selected from the group consisting of generalized anxiety disorder (GAD), specific phobia, social anxiety disorder, separation anxiety disorder, agoraphobia, panic disorder, and selective mutism.

42 . The method of claim 33 , wherein the Enterococcus faecium bacteria strain is live and capable of at least partially colonizing an intestine of the subject.

43 . The method of claim 33 , further comprising administering an additional therapeutic agent.

44 . The method of claim 33 , wherein said administering comprises oral, rectal, nasal, buccal, sublingual, or subcutaneous administration.

45 . The method of claim 33 , wherein the pharmaceutical composition is formulated for delivery to an intestine of the subject.

46 . The method of claim 33 , wherein the Enterococcus faecium bacteria strain comprises a polynucleotide sequence of a 16S rRNA gene that has at least 99% sequence identity to the polynucleotide sequence of SEQ ID NO:2, as determined by a Smith-Waterman homology search algorithm using an affine gap search with a gap open penalty of 12, a gap extension penalty of 2, and a Blocks Substitution Matrix (BLOSUM) of 62.

47 . The method of claim 33 , wherein the Enterococcus faecium bacteria strain comprises the polynucleotide sequence of SEQ ID NO:2.

48 . The method of claim 33 , wherein the Enterococcus faecium bacteria strain is the bacteria strain deposited under accession number NCIMB 42487.

49 . The method of claim 33 , wherein the subject is human.

50 . A method of treating a behavioral or psychiatric condition in a subject in need thereof, comprising administering to the subject a pharmaceutical composition that comprises a therapeutically effective amount of a bacteria strain of the species Enterococcus faecium, wherein the Enterococcus faecium bacteria strain comprises a polynucleotide sequence of a 16S rRNA gene that has at least 95% sequence identity to the polynucleotide sequence of SEQ ID NO:2, as determined by a Smith-Waterman homology search algorithm using an affine gap search with a gap open penalty of 12, a gap extension penalty of 2, and a Blocks Substitution Matrix (BLOSUM) of 62, and wherein the administering treats the behavioral or psychiatric condition in the subject.

51 . The method of claim 50 , wherein the therapeutically effective amount of the Enterococcus faecium bacteria strain comprises at least 1×10 3 CFU/g of the Enterococcus faecium bacteria strain with respect to a total weight of the pharmaceutical composition.

52 . The method of claim 50 , wherein the therapeutically effective amount of the Enterococcus faecium bacteria strain comprises from about 1×10 6 to about 1×10 11 CFU/g of the Enterococcus faecium bacteria strain with respect to a total weight of the pharmaceutical composition.

53 . The method of claim 50 , wherein the behavioral or psychiatric condition comprises a repetitive behavior, a compulsive behavior, or an anxious behavior.

54 . The method of claim 50 , wherein the bacteria strain comprises a 16S rRNA gene sequence that has at least 99% sequence identity to the polynucleotide sequence of SEQ ID NO:2, as determined by a Smith-Waterman homology search algorithm using an affine gap search with a gap open penalty of 12, a gap extension penalty of 2, and a Blocks Substitution Matrix (BLOSUM) of 62.

55 . The method of claim 50 , wherein the Enterococcus faecium bacteria strain is live and capable of at least partially colonizing an intestine of the subject.

56 . The method of claim 50 , wherein the Enterococcus faecium bacteria strain comprises the polynucleotide sequence of SEQ ID NO:2.

57 . The method of claim 50 , wherein the Enterococcus faecium bacteria strain is the bacteria strain deposited under accession number NCIMB 42487.

58 . The method of claim 50 , wherein the subject is human.

59 . A method of treating a behavioral or psychiatric condition in a subject suffering from a neurocognitive disorder, comprising administering to the subject a pharmaceutical composition that comprises a therapeutically effective amount of a bacteria strain of the species Enterococcus faecium, wherein the Enterococcus faecium bacteria strain comprises a polynucleotide sequence of a 16S rRNA gene that has at least 99% sequence identity to the polynucleotide sequence of SEQ ID NO:2, as determined by a Smith-Waterman homology search algorithm using an affine gap search with a gap open penalty of 12, a gap extension penalty of 2, and a Blocks Substitution Matrix (BLOSUM) of 62, wherein the administering treats the behavioral or psychiatric condition in a subject suffering from the neurocognitive disorder.

60 . The method of claim 59 , wherein the neurocognitive disorder is selected from the group consisting of Alzheimer's disease, vascular dementias, Lewy body disease, frontotemporal dementia, Parkinson's disease, Creutzfeldt-Jakob disease, Huntington's disease, and Wernicke-Korsakoff syndrome.

61 . The method of claim 59 , wherein the therapeutically effective amount of the Enterococcus faecium bacteria strain comprises at least 1×10 3 CFU/g of the Enterococcus faecium bacteria strain with respect to a total weight of the pharmaceutical composition.

62 . The method of claim 59 , wherein the therapeutically effective amount of the Enterococcus faecium bacteria strain comprises from about 1×10 6 to about 1×10 11 CFU/g of the Enterococcus faecium bacteria strain with respect to a total weight of the pharmaceutical composition.

63 . The method of claim 59 , wherein the behavioral or psychiatric condition comprises a repetitive behavior, a compulsive behavior, or an anxious behavior.

64 . The method of claim 59 , wherein the bacteria strain comprises a 16S rRNA gene sequence that has at least 99% sequence identity to the polynucleotide sequence of SEQ ID NO:2, as determined by a Smith-Waterman homology search algorithm using an affine gap search with a gap open penalty of 12, a gap extension penalty of 2, and a Blocks Substitution Matrix (BLOSUM) of 62.

65 . The method of claim 59 , wherein the Enterococcus faecium bacteria strain comprises the polynucleotide sequence of SEQ ID NO:2.

66 . The method of claim 59 , wherein the Enterococcus faecium bacteria strain is the bacteria strain deposited under accession number NCIMB 42487.

67 . The method of claim 59 , wherein the subject is human.

Assignments (3)
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 Mar 26, 2021
From: SAVIGNAC, HELENE MYRIAM; MULDER, IMKE ELISABETH; SAVIGNAC, HELENE; CRYAN, JOHN
To: 4D PHARMA RESEARCH LIMITED
Reel/Frame 055728/0001 →