US2022096565A1PendingUtilityA1

Compositions comprising bacterial strains

Assignee: 4D PHARMA RES LTDPriority: Jun 14, 2017Filed: Aug 19, 2021Published: Mar 31, 2022
Est. expiryJun 14, 2037(~10.9 yrs left)· nominal 20-yr term from priority
A61K 9/19A61K 35/74A61P 25/00A61P 37/00A61K 9/0053
62
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Claims

Abstract

The invention provides compositions comprising bacterial strains for treating and preventing a neurodegenerative disorder.

Claims

exact text as granted — not AI-modified
1 .- 34 . (canceled) 
     
     
         35 . A pharmaceutical composition comprising a bacterial strain of the genus  Roseburia  in a therapeutically effective amount for reducing a level of a proinflammatory cytokine in a subject when administered to the subject, and a pharmaceutically acceptable excipient, diluent, or carrier, wherein:
 (a) the bacterial strain is lyophilized,   (b) the pharmaceutical composition does not comprise a therapeutically effective amount of any other strain, and   (c) the pharmaceutical composition is formulated in an enteric capsule for delivery to an intestine of the subject.   
     
     
         36 . The pharmaceutical composition of  claim 35 , wherein the proinflammatory cytokine is interleukin 6 (IL-6). 
     
     
         37 . The pharmaceutical composition of  claim 35 , wherein the therapeutically effective amount comprises from about 1×10 3  to about 1×10 11  colony forming units (CFU). 
     
     
         38 . The pharmaceutical composition of  claim 35 , wherein the pharmaceutical composition comprises from about 1×10 6  to about 1×10 11  colony forming units per gram (CFU/g), with respect to the weight of the pharmaceutical composition. 
     
     
         39 . The pharmaceutical composition of  claim 35 , wherein the bacterial strain is of the species  Roseburia hominis, Roseburia intestinalis , or  Roseburia  faecis. 
     
     
         40 . The pharmaceutical composition of  claim 35 , wherein the bacterial strain comprises a 16S rRNA gene sequence that has at least 95% sequence identity to the polynucleotide sequence of SEQ ID NO:3, SEQ ID NO: 5, or SEQ ID NO:6. 
     
     
         41 . The pharmaceutical composition of  claim 35 , wherein the bacterial strain comprises a 16S rRNA gene sequence that has at least 98% sequence identity to the polynucleotide sequence of SEQ ID NO:3, SEQ ID NO: 5, or SEQ ID NO:6. 
     
     
         42 . The pharmaceutical composition of  claim 35 , wherein the bacterial strain comprises a 16S rRNA gene sequence of SEQ ID NO:3, SEQ ID NO: 5, or SEQ ID NO:6. 
     
     
         43 . The pharmaceutical composition of  claim 35 , wherein the bacterial strain is the strain deposited under accession number NCIMB 42383, the strain deposited under accession number NCIMB 43043, or a biotype thereof. 
     
     
         44 . The pharmaceutical composition of  claim 43 , wherein the biotype is a bacterial strain that has the same carbohydrate fermentation pattern as the strain deposited under accession number NCIMB 42383 or the strain deposited under accession number NCIMB 43043. 
     
     
         45 . The pharmaceutical composition of  claim 35 , wherein the bacterial strain is capable of at least partially colonizing an intestine of the subject. 
     
     
         46 . The pharmaceutical composition of  claim 35 , wherein the pharmaceutical composition is formulated for oral administration. 
     
     
         47 . The pharmaceutical composition of  claim 35 , wherein the bacterial strain is live. 
     
     
         48 . A pharmaceutical composition comprising a bacterial strain of the genus  Roseburia  in a therapeutically effective amount for reducing a level of the NFκB promoter activation in a subject and a pharmaceutically acceptable excipient, diluent, or carrier, wherein:
 (a) the bacterial strain is lyophilized, 
 (b) the pharmaceutical composition does not comprise a therapeutically effective amount of any other strain, and 
 (c) the pharmaceutical composition is formulated in an enteric capsule for delivery to an intestine of the subject. 
 
     
     
         49 . A method of treating a neurodegenerative disorder in a subject in need thereof comprising administering to the subject a composition comprising a therapeutically effective amount of a bacterial strain of the genus  Roseburia , wherein the bacterial strain comprises a 16S rRNA gene sequence that has at least 95% sequence identity to the polynucleotide sequence of SEQ ID NO:3, SEQ ID NO: 5, or SEQ ID NO:6, and wherein the administering is effective to treat the neurodegenerative disorder. 
     
     
         50 . The method of  claim 49 , wherein the administering is effective to reduce a level of a proinflammatory cytokine in the subject. 
     
     
         51 . The method of  claim 49 , wherein the proinflammatory cytokine is interleukin 6 (TL-6). 
     
     
         52 . The method of  claim 49 , wherein the therapeutically effective amount comprises from about 1×10 3  to about 1×10 11  colony forming units (CFU). 
     
     
         53 . The method of  claim 49 , wherein the composition comprises no more than de minimis amounts of other bacterial strains. 
     
     
         54 . The method of  claim 49 , wherein the composition further comprises a pharmaceutically acceptable excipient, diluent, or carrier.

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