Synergistic bacterial compositions and methods of production and use thereof

Patent metadata

Field	Value
Publication number	US-12083151-B2
Application number	US-202217938184-A
Country	US
Kind code	B2
Filing date	Oct 5, 2022
Priority date	Nov 23, 2012
Publication date	Sep 10, 2024
Grant date	Sep 10, 2024

Abstract

Provided are therapeutic compositions containing Ecobiotic™ 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 a first species of isolated bacterium, a second species of isolated bacterium, and a capsule; wherein the first species is Clostridium symbiosum and the second species is Clostridium orbiscindens ; wherein the Clostridium orbiscindens comprises a 16S rDNA sequence that is at least 97% identical to SEQ ID NO: 548, wherein the first species and the second species are capable of inhibiting Clostridium difficile ( C. difficile ) growth as measured by a CivSim assay; and wherein the capsule encapsulates the first species and the second species.

2. The composition of claim 1 , wherein the first species and the second species are capable of inhibiting C. difficile growth in the CivSim assay with a confidence interval of >99% (+++).

3. The composition of claim 1 , wherein the first species, the second species, or both are in the form of spores.

4. The composition of claim 1 , which is formulated for populating the gastrointestinal tract of the subject.

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

6. A single dose unit comprising a first species of isolated bacterium, and a second species of isolated bacterium, and a capsule; wherein the first species and the second species are capable of inhibiting Clostridium difficile ( C. difficile ) growth as measured by a CivSim assay and/or populating the gastrointestinal tract of a subject; wherein the first species is Clostridium symbiosum and the second species is Clostridium orbiscindens ; wherein the Clostridium orbiscindens comprises a 16S rDNA sequence that is at least 97% identical to SEQ ID NO: 548, and wherein the capsule encapsulates the first species and the second species.

7. A kit comprising in one or more containers the composition of claim 1 .

8. A pharmaceutical formulation comprising the composition of claim 1 .

9. The pharmaceutical formulation of claim 8 , further comprising an additional agent.

10. A method of producing a bacterial composition, comprising combining a first species of isolated bacterium and a second species of isolated bacterium, wherein the first species is Clostridium symbiosum and the second species is Clostridium orbiscindens , wherein the Clostridium orbiscindens comprises a 16S rDNA sequence that is at least 97% identical to SEQ ID NO: 548, and wherein the first species and the second species are capable of inhibiting Clostridium difficile ( C. difficile ) growth and/or populating the gastrointestinal tract of a subject.

11. The method of claim 10 , wherein the first species and the second species are lyophilized.

12. The composition of claim 1 , wherein the Clostridium orbiscindens comprises a 16S rDNA sequence that is at least 98% identical to SEQ ID NO: 548.

13. The composition of claim 1 , wherein the Clostridium orbiscindens comprises a 16S rDNA sequence that is at least 99% identical to SEQ ID NO: 548.

14. The composition of claim 1 , wherein the Clostridium orbiscindens comprises the 16S rDNA sequence set forth in SEQ ID NO: 548.

15. The single dose unit of claim 6 , wherein the Clostridium orbiscindens comprises a 16S rDNA sequence that is at least 98% identical to SEQ ID NO: 548.

16. The single dose unit of claim 6 , wherein the Clostridium orbiscindens comprises a 16S rDNA sequence that is at least 99% identical to SEQ ID NO: 548.

17. The single dose unit of claim 6 , wherein the Clostridium orbiscindens comprises the 16S rDNA sequence set forth in SEQ ID NO: 548.

18. The method of claim 10 , wherein the Clostridium orbiscindens comprises a 16S rDNA sequence that is at least 98% identical to SEQ ID NO: 548.

19. The method of claim 10 , wherein the Clostridium orbiscindens comprises a 16S rDNA sequence that is at least 99% identical to SEQ ID NO: 548.

20. The method of claim 10 , wherein the Clostridium orbiscindens comprises the 16S rDNA sequence set forth in SEQ ID NO: 548.

Assignees

• Seres Therapeutics Inc

Inventors

• Henn Matthew R
• Von Maltzahn Geoffrey
• D'Onofrio Anthony Mario
• Litcofsky Kevin Daniel
• Berry David Arthur
• Cook David N
• Afeyan Noubar B
• Aunins John Grant

Classifications

• A61K45/06

  Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca · CPC title

• A61K38/13

  Cyclosporins · CPC title

• A61K35/74 Primary

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

• A61K9/4891

  Coated capsules; Multilayered drug free capsule shells (with drug coating for immediate release A61K9/4808; osmotic devices A61K9/0004) · CPC title

• A61K9/0053

  Mouth and digestive tract, i.e. intraoral and peroral administration · CPC title