US2020171098A1PendingUtilityA1

Compositions comprising bacterial strains

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Assignee: 4D PHARMA RES LTDPriority: Nov 20, 2015Filed: Sep 16, 2019Published: Jun 4, 2020
Est. expiryNov 20, 2035(~9.4 yrs left)· nominal 20-yr term from priority
A61K 35/744A61K 9/0053A61K 9/19A61K 9/50A61K 2039/585A23L 33/135A61K 39/09A23C 9/1585A61K 35/74A61P 43/00A61P 37/08A61P 37/06A61P 37/02A61P 37/00A61P 35/00A61P 29/00A61P 27/02A61P 25/00A61P 21/00A61P 19/02A61P 17/06A61P 17/00A61P 11/06A61P 11/02A61P 11/00A61P 9/10A61P 9/00A61P 1/04A61P 1/02A61K 2039/52A61K 2035/11A23V 2002/00Y02A50/30
69
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Claims

Abstract

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

Claims

exact text as granted — not AI-modified
1 .- 30 . (canceled) 
     
     
         31 . A pharmaceutical composition that comprises an amount of a live bacteria strain of species  Enterococcus faecium  and a pharmaceutically effective excipient, diluent, or carrier; wherein said  Enterococcus faecium  bacteria strain comprises a polynucleotide sequence that is a 16 s rRNA gene sequence with at least 95% sequence identity to 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 BLOSUM matrix of 62. 
     
     
         32 . The pharmaceutical composition of  claim 31 , wherein said amount of said  Enterococcus faecium  bacteria strain is effective to reduce a degree of infiltration of inflammatory cells in a retinal tissue when administered to a subject, relative to a degree of infiltration of said inflammatory cells in said retinal tissue of said subject prior to said administering. 
     
     
         33 . The pharmaceutical composition of  claim 31 , wherein said  Enterococcus faecium  bacteria strain is positive for fermentation of mannose, as determined by a Rapid ID 32A analysis. 
     
     
         34 . The pharmaceutical composition of  claim 31 , wherein said  Enterococcus faecium  bacteria strain is positive for serine arylamidase, as determined by said Rapid ID 32A analysis. 
     
     
         35 . The pharmaceutical composition of  claim 31 , wherein said  Enterococcus faecium  bacteria strain is intermediate for N-acetyl-β-glucosaminidase by said Rapid ID 32A analysis. 
     
     
         36 . The pharmaceutical composition of  claim 31 , wherein said pharmaceutical composition is lyophilized. 
     
     
         37 . The pharmaceutical composition of  claim 31 , wherein said  Enterococcus faecium  bacteria strain is the sole bacteria strain present in said pharmaceutical composition. 
     
     
         38 . The pharmaceutical composition of  claim 31 , formulated for oral delivery. 
     
     
         39 . The pharmaceutical composition of  claim 31 , formulated for rectal delivery. 
     
     
         40 . The pharmaceutical composition of  claim 31 , formulated as an injectable formulation. 
     
     
         41 . The pharmaceutical composition of  claim 31 , in the form of a tablet, a capsule, or a powder. 
     
     
         42 . The pharmaceutical composition of  claim 31 , wherein at least 50% of said  Enterococcus faecium  bacteria strain as measured by an amount of colony forming units (CFU), remains viable after about 1 year of storage when said pharmaceutical composition is stored in a closed container at 25° C. at 95% relative humidity. 
     
     
         43 . The pharmaceutical composition of  claim 31 , wherein said pharmaceutical composition is encapsulated. 
     
     
         44 . The pharmaceutical composition of  claim 31 , wherein said pharmaceutical composition is an enteric formulation. 
     
     
         45 . The pharmaceutical composition of  claim 44 , wherein said enteric formulation comprises an enteric coating. 
     
     
         46 . The pharmaceutical composition of  claim 31 , further comprising a prebiotic compound selected from the group consisting of: a fructo-oligosaccharide, a short-chain fructooligosaccharide, 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.

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