Synergistic bacterial compositions and methods of production and use thereof

Patent metadata

Field	Value
Publication number	US-11266699-B2
Application number	US-201816230807-A
Country	US
Kind code	B2
Filing date	Dec 21, 2018
Priority date	Nov 25, 2013
Publication date	Mar 8, 2022
Grant date	Mar 8, 2022

Abstract

Provided are therapeutic compositions containing microbial populations for prevention, treatment and reduction of symptoms associated with a dysbiosis of a mammalian subject such as a human.

First claim

What is claimed is:

1. A composition comprising at least a first species of an isolated bacterium capable of forming a spore, a second species of isolated bacterium capable of forming a spore, and a third species of isolated bacterium capable of forming a spore, wherein the first species, the second species, and the third species are not identical, wherein the first species comprises Clostridium bolteae , the second species comprises Clostridium orbiscindens , and the third species comprises Blautia producta , wherein the Clostridium orbiscindens comprises a 16S rDNA sequence that is at least 97% identical to SEQ ID NO: 609, wherein a combination of the first species, the second species, and the third species is capable of decreasing and/or inhibiting the growth and/or colonization of Clostridium difficile , as measured by a CivSim assay, and wherein the composition further comprises an enteric coating.

2. A single dose unit comprising the composition of claim 1 .

3. A pharmaceutical formulation comprising an effective amount of the composition of claim 1 .

4. The composition of claim 1 , wherein the first species, the second species, the third species, or combinations thereof are in the form of spores.

5. The composition of claim 1 , wherein the first species, the second species, the third species, or combinations thereof are lyophilized.

6. The composition of claim 1 , wherein the first species, the second species, the third species, or combinations thereof are present in the composition at the same dosage amount.

7. A method of producing a bacterial composition, comprising combining at least a first species of isolated bacterium capable of forming a spore, a second species of isolated bacterium capable of forming a spore, and a third species of isolated bacterium capable of forming a spore, wherein the first species, the second species, and the third species are not identical, wherein the first species comprises Clostridium bolteae , the second species comprises Clostridium orbiscindens , and the third species comprises Blautia producta , wherein the Clostridium orbiscindens comprises a 16S rDNA sequence that is at least 97% identical to the 16S rDNA sequence set forth in SEQ ID NO: 609, wherein a combination of the first species, the second species, and the third species can decrease and/or inhibit the growth and/or colonization of Clostridium difficile , as measured by a CivSim assay, and wherein the bacterial composition further comprises an enteric coating.

8. The composition of claim 1 , wherein the Clostridium orbiscindens comprises a 16S rDNA sequence that is at least 98% identical to SEQ ID NO: 609.

9. The composition of claim 1 , wherein the Clostridium orbiscindens comprises a 16S rDNA sequence that is at least 99% identical to SEQ ID NO: 609.

10. The composition of claim 1 , wherein the Clostridium orbiscindens comprises the 16S rDNA sequence set forth in SEQ ID NO: 609.

11. The pharmaceutical formulation of claim 3 , further comprising an effective amount of an anti-fungal agent, an anti-bacterial agent, an anti-viral agent, an anti-parasitic agent, or combinations thereof.

12. The composition of claim 1 , wherein the Clostridium bolteae comprises a 16S rDNA sequence that is at least 97% identical to SEQ ID NO: 559.

13. The composition of claim 1 , wherein the Clostridium bolteae comprises a 16S rDNA sequence that is at least 98% identical to SEQ ID NO: 559.

14. The composition of claim 1 , wherein the Clostridium bolteae comprises a 16S rDNA sequence that is at least 99% identical to SEQ ID NO: 559.

15. The composition of claim 1 , wherein the Clostridium bolteae comprises the 16S rDNA sequence set forth in SEQ ID NO: 559.

16. The composition of claim 1 , wherein the Blautia producta comprises a 16S rDNA sequence that is at least 97% identical to SEQ ID NO: 379.

17. The composition of claim 1 , wherein the Blautia producta comprises a 16S rDNA sequence that is at least 98% identical to SEQ ID NO: 379.

18. The composition of claim 1 , wherein the Blautia producta comprises a 16S rDNA sequence that is at least 99% identical to SEQ ID NO: 379.

19. The composition of claim 1 , wherein the Blautia producta comprises the 16S rDNA sequence set forth in SEQ ID NO: 379.

20. The pharmaceutical formulation of claim 3 , which is formulated for oral administration.

Assignees

• Seres Therapeutics Inc

Inventors

• Henn Matthew R
• Litcofsky Kevin Daniel
• D'Onofrio Anthony Mario
• Ohsumi Toshiro K
• Mckenzie Mary-Jane Lombardo
• Von Maltzahn Geoffrey
• Cook David N
• Berry David Arthur
• Afeyan Noubar B
• Aunins John Grant

Classifications

• Y02A50/30

  Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change · CPC title

• A61K2035/115

  Probiotics · CPC title

• A61K2035/11

  Medicinal preparations comprising living procariotic cells · CPC title

• A61K35/74 Primary

  Bacteria (therapeutic use of a bacterial protein A61K38/00) · CPC title

• A61P1/04

  for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants · CPC title