IP Library Granted Patent US 10,675,312
Granted Patent B2
US 10,675,312 · App. 16/159,536 · Granted Jun 9, 2020

Methods and compositions relating to microbial treatment and diagnosis of disorders

Inventors: Colleen Cutcliffe (Menlo Park, CA); John S. Eid (San Francisco, CA); James H. Bullard (San Francisco, CA); Marcus F. Schicklberger (Richmond, CA)
Assignee: Pendulum Therapeutics, Inc.
A61K35/745A23L33/135A61K9/0053A61K9/2846A61K9/48A61K9/4816A61K9/4891A61K31/00A61K31/733A61K35/74A61K35/741A61K35/742A61K45/06C12N1/20C12Q1/689G01N33/66A23V2002/00A61K2035/115G01N2333/605G01N2800/04
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Quick Facts
Patent No.
US 10,675,312
App. No.
16/159,536
Granted
Jun 9, 2020
Kind
B2
Abstract

The present disclosure provides methods, systems, compositions, and kits to address the need for microbiome-related treatment of health conditions and disease. The present disclosure provides for treatment of metabolic conditions using microbial compositions.

Claims (41)

1. A method of treating a metabolic disorder in a subject, the method comprising:

administering to the subject a composition comprising:

a) a first microbe comprising a 16S rRNA sequence comprising at least about 97% sequence identity to a 16S rRNA sequence of Akkermansia muciniphila;

b) a second microbe comprising a 16S rRNA sequence comprising at least about 97% sequence identity to a 16S rRNA sequence of Eubacterium hallii; and

c) a third microbe comprising a 16S rRNA sequence comprising at least 97% sequence identity to a 16S rRNA sequence of Clostridium beijerinckii;

thereby treating the metabolic disorder, wherein the metabolic disorder is selected from the group consisting of Type 2 Diabetes Mellitus, Type 1 Diabetes Mellitus, obesity, and insulin resistance.

2. The method of claim 1 , wherein the first microbe is Akkermansia muciniphila.

3. The method of claim 1 , wherein the composition further comprises a fourth microbe, wherein the fourth microbe comprises a 16S rRNA sequence that comprises at least about 97% sequence identity to a 16S rRNA sequence of a microbe selected from the group consisting of: Bifidobacterium infantis, Clostridium butyricum, Clostridium indolis, and Faecalibacterium prausnitzii.

4. The method of claim 1 , wherein the composition further comprises one or more of: Bifidobacterium infantis, Clostridium butyricum, Clostridium indolis , or Faecalibacterium prausnitzii.

5. The method of claim 1 , wherein the composition further comprises Bifidobacterium infantis.

6. The method of claim 1 , wherein the composition does not contain dairy.

7. The method of claim 1 , wherein the composition is administered daily.

8. The method of claim 1 , wherein the composition is administered at least twice daily.

9. The method of claim 1 , wherein the composition is in a form of a capsule.

10. The method of claim 1 , wherein the composition is a food composition in a form of a bar.

11. The method of claim 1 , wherein the metabolic disorder is Type 2 diabetes mellitus.

12. The method of claim 1 , wherein the second microbe is Eubacterium hallii.

13. The method of claim 1 , wherein the first microbe, the second microbe, or the third microbe has been grown substantially on plant-based media.

14. The method of claim 13 , wherein the plant-based media comprises an amino acid source that is a plant-protein hydrolysate.

15. The method of claim 1 , wherein the third microbe is Clostridium beijerinckii.

16. A method of treating a metabolic disorder in a subject, the method comprising:

administering to the subject a composition comprising:

a) a first microbe comprising a 16S rRNA sequence comprising at least about 85% sequence identity to a 16S rRNA sequence of Akkermansia muciniphila;

b) a second microbe comprising a 16S rRNA sequence comprising at least about 85% sequence identity to a 16S rRNA sequence of Eubacterium hallii; and

c) a third microbe comprising a 16S rRNA sequence comprising at least about 85% sequence identity to a 16S rRNA sequence of Clostridium beijerinckii;

thereby treating the metabolic disorder, wherein the metabolic disorder is selected from the group consisting of Type 2 Diabetes Mellitus, Type 1 Diabetes Mellitus, obesity, and insulin resistance.

17. The method of claim 16 , wherein the first microbe is Akkermansia muciniphila.

18. The method of claim 16 , wherein the composition is administered daily.

19. The method of claim 16 , wherein the composition is in a form of a capsule.

20. The method of claim 16 , wherein the composition is a food composition in a form of a bar.

21. The method of claim 16 , wherein the composition does not contain dairy.

22. The method of claim 16 , wherein the composition further comprises a fourth microbe, wherein the fourth microbe comprises a 16S rRNA sequence that comprises at least about 85% sequence identity to a 16S rRNA sequence from a microbe selected from the group consisting of: Bifidobacterium infantis, Clostridium butyricum, Clostridium indolis , and Faecalibacterium prausnitzii.

23. The method of claim 16 , wherein the composition further comprises Bifidobacterium infantis.

24. The method of claim 16 , wherein the metabolic disorder is Type 2 diabetes mellitus.

25. The method of claim 16 , wherein the composition further comprises one or more of: Bifidobacterium infantis, Clostridium butyricum, Clostridium indolis , or Faecalibacterium prausnitzii.

26. The method of claim 16 , wherein the second microbe is Eubacterium hallii.

27. The method of claim 16 , wherein the composition comprises at least 1×10 5 CFUs of the first microbe, the second microbe, the third microbe, or a combination thereof.

28. The method of claim 16 , wherein the third microbe is Clostridium beijerinckii.

29. The method of claim 16 , wherein the composition further comprises an excipient comprising a growth media, wherein the growth media is a substantially plant-based media.

30. The method of claim 29 , wherein the substantially plant-based media is in a powdered form in the composition.

31. The method of claim 29 , wherein the substantially plant-based media comprises an amino acid source that is a plant-protein hydrolysate.

Assignments (3)
SECURITY INTEREST Recorded Jan 18, 2022
From: PENDULUM THERAPEUTICS, INC.
To: TRINITY CAPITAL INC.
Reel/Frame 058678/0276 →
CHANGE OF NAME Recorded Sep 29, 2019
From: WHOLE BIOME INC.
To: PENDULUM THERAPEUTICS, INC.
Reel/Frame 050581/0909 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 15, 2018
From: CUTCLIFFE, COLLEEN; EID, JOHN S.; BULLARD, JAMES H.; SCHICKLBERGER, MARCUS F.
To: WHOLE BIOME INC.
Reel/Frame 047170/0329 →
Cited By (3)
US 12,233,095 US 12,343,360 US 12,544,412