Compositions and methods for treating cholestatic disease

Patent metadata

Field	Value
Publication number	US-11701394-B2
Application number	US-201816639492-A
Country	US
Kind code	B2
Filing date	Aug 14, 2018
Priority date	Aug 14, 2017
Publication date	Jul 18, 2023
Grant date	Jul 18, 2023

Abstract

The invention provides compositions and methods for use in the treatment and prevention of cholestatic diseases.

First claim

What is claimed is:

1. A method of reducing a side effect of a treatment for a cholestatic disease or condition in a subject in need thereof, comprising administering to the subject a composition which comprises a first bacterial species and a second bacterial species, wherein the first bacterial species and the second bacterial species are not the same, wherein the first bacterial species and the second bacterial species are selected from: Alistipes finegoldii, Bacteroides uniformis, Bacteroides vulgatus, Bacteroides sp_3_1_19 , Bacteroides intestinalis, Bacteroides sp_20_3 , Bacteroides caccae, Bacteroides faecis, Bacteroides sp_3_1_23 , Bacteroides sp_D20 , Bacteroides eggerthii, Barnesiella intestinihominis, Bifidobacterium pseudocatenulatum, Blautia schinkii, Blautia wexlerae, Blautia sp_M25 , Blautia producta, Clostridiales sp_SM4_1 , Clostridium lavalense, Clostridium innocuum, Clostridium asparagiforme, Clostridium spiroforme, Clostridium hylemonae, Clostridium sordellii, Clostridium sp_YIT_12069 , Clostridium paraputrificum, Clostridium glycolicum, Clostridium ghonii, Clostridium lactifermentans, Clostridium viride, Clostridium sp_HGF2 , Clostridium symbiosum, Clostridium scindens, Clostridium disporicum, Clostridium butyricum, Clostridium orbiscindens, Clostridium bolteae, Clostridium sp_7_2_43FAA, Collinsella aerofaciens, Coprobacillus sp_D7 , Coprococcus comes, Coprococcus eutactus, Dorea longicatena, Dorea formicigenerans, Erysipelotrichaceae bacterium _3_1_53 , Eubacterium sp_3_1_31 , Eubacterium sp_WAL_14571 , Eubacterium limosum, Eubacterium hallii, Eubacterium rectale, Eubacterium contortum, Gemmiger formicillis, Lachnospiraceae bacterium _2_1_58FAA, Lachnospiraceae bacterium _9_1_43BFAA, Lachnospiraceae bacterium _3_1_57FAA_CT1 , Lachnospiraceae bacterium _5_1_57FAA, Lachnospiraceae bacterium _ oral _ taxon _F15 , Lactobacillus acidophilus, Lactobacillus gasseri, Parabacteroides distasonis, Pseudoflavonifractor capillosus, Roseburia faecis, Ruminococcus obeum, Ruminococcus bromii, Ruminococcus lactaris , or Tannerella sp_6_1_58FAA, and wherein the first species, the second species, or both are capable of enhancing the efficacy of the treatment, such that the treatment can be administered to the subject at a lower dose, at reduced frequency, or both.

2. The method of claim 1 , wherein the first species, the second species, or both are not capable of increasing lithocholic acid (LCA) level in the subject.

3. The method of claim 1 , wherein the side effect comprises pruritus.

4. The method of claim 1 , wherein the treatment comprises ursodeoxycholic acid (UDCA), obeticholic acid (OCA), or both.

5. The method of claim 1 , wherein the first species, the second species, or both are capable of increasing the subject's tolerance for the treatment.

6. The method of claim 1 , wherein:
(1) the Alistipes finegoldii comprises a 16S rDNA sequence that is at least 95% identical to the sequence set forth in SEQ ID NO: 7;
(2) the Bacteroides uniformis comprises a 16S rDNA sequence that is at least 95% identical to the sequence set forth in SEQ ID NO: 45;
(3) the Bacteroides vulgatus comprises a 16S rDNA sequence that is at least 95% identical to the sequence set forth in any one of SEQ ID NO: 53, SEQ ID NO: 54, SEQ ID NO: 55, or a combination thereof;
(4) the Bacteroides sp_3_1_19 comprises a 16S rDNA sequence that is at least 95% identical to the sequence set forth in SEQ ID NO: 33;
(5) the Bacteroides intestinalis comprises a 16S rDNA sequence that is at least 95% identical to the sequence set forth in SEQ ID NO: 22;
(6) the Bacteroides sp_20_3 comprises a 16S rDNA sequence that is at least 95% identical to the sequence set forth in SEQ ID NO: 20;
(7) the Bacteroides caccae comprises a 16S rDNA sequence that is at least 95% identical to the sequence set forth in SEQ ID NO: 9, SEQ ID NO: 10, or both;
(8) the Bacteroides faecis comprises a 16S rDNA sequence that is at least 95% identical to the sequence set forth in SEQ ID NO: 13;
(9) the Bacteroides sp_3_1_23 comprises a 16S rDNA sequence that is at least 95% identical to the sequence set forth in SEQ ID NO: 34;
(10) the Bacteroides sp_D20 comprises a 16S rDNA sequence that is at least 95% identical to the sequence set forth in SEQ ID NO: 39;
(11) the Bacteroides eggerthii comprises a 16S rDNA sequence that is at least 95% identical to the sequence set forth in SEQ ID NO: 12;
(12) the Barnesiella intestinihominis comprises a 16S rDNA sequence that is at least 95% identical to the sequence set forth in SEQ ID NO: 59;
(13) the Bifidobacterium pseudocatenulatum comprises a 16S rDNA sequence that is at least 95% identical to the sequence set forth in SEQ ID NO: 113, SEQ ID NO: 114, or both;
(14) the Blautia schinkii comprises a 16S rDNA sequence that is at least 95% identical to the sequence set forth in SEQ ID NO: 130;
(15) the Blautia wexlerae comprises a 16S rDNA sequence that is at least 95% identical to the sequence set forth in SEQ ID NO: 133;
(16) the Blautia sp_M25 comprises a 16S rDNA sequence that is at least 95% identical to the sequence set forth in SEQ ID NO: 131;
(17) the Blautia producta comprises a 16S rDNA sequence that is at least 95% identical to the sequence set forth in SEQ ID NO: 128, SEQ ID NO: 129, or both;
(18) the Clostridiales sp_SM4_1 comprises a 16S rDNA sequence that is at least 95% identical to the sequence set forth in SEQ ID NO: 142;
(19) the Clostridium lavalense comprises a 16S rDNA sequence that is at least 95% identical to the sequence set forth in SEQ ID NO: 184;
(20) the Clostridium innocuum comprises a 16S rDNA sequence that is at least 95% identical to the sequence set forth in any one of SEQ ID NO: 179, SEQ ID NO: 180, SEQ ID NO: 181, SEQ ID NO: 182, or a combination thereof;
(21) the Clostridium asparagiforme comprises a 16S rDNA sequence that is at least 95% identical to the sequence set forth in SEQ ID NO: 143;
(22) the Clostridium spiroforme comprises a 16S rDNA sequence that is at least 95% identical to the sequence set forth in SEQ ID NO: 194;
(23) the Clostridium hylemonae comprises a 16S rDNA sequence that is at least 95% identical to the sequence set forth in any one of SEQ ID NO: 176, SEQ ID NO: 177, SEQ ID NO: 178, or a combination thereof;
(24) the Clostridium sordellii comprises a 16S rDNA sequence that is at least 95% identical to the sequence set forth in SEQ ID NO: 190;
(25) the Clostridium sp_YIT_12069 comprises a 16S rDNA sequence that is at least 95% identical to the sequence set forth in SEQ ID NO: 197;
(26) the Clostridium paraputrificum comprises a 16S rDNA sequence that is at least 95% identical to the sequence set forth in SEQ ID NO: 188;
(27) the Clostridium glycolicum comprises a 16S rDNA sequence that is at least 95% identical to the sequence set forth in SEQ ID NO: 173;
(28) the Clostridium ghonii comprises a 16S rDNA sequence that is at least 95% identical to the sequence set forth in SEQ ID NO: 172;
(29) the Clostridium viride comprises a 16S rDNA sequence that is at least 95% identical to the sequence set forth in SEQ ID NO: 200;
(30) the Clostridium sp_HGF2 comprises a 16S rDNA sequence that is at least 95% identical to the sequence set forth in SEQ ID NO: 193;
(31) the Clostridium symbiosum comprises a 16S rDNA sequence that is at least 95% identical to the sequence set forth in SEQ ID NO: 198, SEQ ID NO: 199, or both;
(32) the Clostridium scindens comprises a 16S rDNA sequence that is at least 95% identical to the sequence set forth in SEQ ID NO: 189;
(33) the Clostridium disporicum comprises a 16S rDNA sequence that is at least 95% identical to the sequence set forth in SEQ ID NO: 170, SEQ ID NO: 171, or both;
(34) the Clostridium butyricum comprises a 16S

Assignees

• Seres Therapeutics Inc

Inventors

• Nandakumar Madhumitha
• Liou Alice Peiyu
• Halvorsen Elizabeth Moritz
• Mckenzie Gregory
• O'Brien Edward J
• Cook David

Classifications

• A61K2300/00

  Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00 · CPC title

• A61K31/575

  substituted in position 17 beta by a chain of three or more carbon atoms, e.g. cholane, cholestane, ergosterol, sitosterol · CPC title

• A61K31/58

  containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin (digitoxin {A61K31/7048}) · CPC title

• A61P1/16

  for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics · CPC title

• A61K35/745 Primary

  Bifidobacteria · CPC title