IP Library Granted Patent US 11,213,556
Granted Patent B2
US 11,213,556 · App. 16/830,995 · Granted Jan 4, 2022

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 11,213,556
App. No.
16/830,995
Granted
Jan 4, 2022
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 (30)

1. An oral dosage form comprising:

a microbe comprising a 16S rRNA sequence comprising at least 97% sequence identity to a 16S rRNA sequence of Eubacterium hallii , and

an enteric coating,

wherein the microbe is a net producer of acetate generated by growing a bacterium comprising a 16S rRNA sequence comprising at least 97% sequence identity to a 16S rRNA sequence of Eubacterium hallii in a substantially plant-based medium comprising yeast extract, a plant-derived peptone, a plant-derived hydrolysate, or a combination thereof.

2. The oral dosage form of claim 1 , wherein the oral dosage form further comprises a carrier or excipient selected from the group consisting of malt, an oil, an oil of petroleum, animal, vegetable or synthetic origin, peanut oil, soybean oil, mineral oil, sesame oil, glycol, propylene glycol, alginate, sodium alginate, a lipid, a granulating agent, and a combination thereof.

3. The oral dosage form of claim 1 , wherein the oral dosage form further comprises an antioxidant, a vitamin, ascorbic acid, a lipid, a mineral, or a combination thereof.

4. The oral dosage form of claim 1 , further comprising a prebiotic.

5. The oral dosage form of claim 4 , wherein the prebiotic comprises dietary fiber, starch, wheat bran, biotin, or a combination thereof.

6. The oral dosage form of claim 1 , wherein the microbe is encapsulated within a suitable vehicle.

7. The oral dosage form of claim 1 , wherein the microbe is encapsulated in a liposome, microsphere, or microparticle.

8. The oral dosage form of claim 1 , wherein the microbe is encapsulated in a suitable vehicle for sustained release.

9. The oral dosage form of claim 1 , wherein the oral dosage form is a liquid that comprises glycerol.

10. The oral dosage form of claim 1 , wherein the substantially plant-based medium is a medium that lacks animal-derived components.

11. The oral dosage form of claim 10 , wherein the medium that lacks animal-derived components comprises an added vitamin or trace mineral.

12. The oral dosage form of claim 11 , wherein the added vitamin or trace mineral comprises biotin, calcium, calcium pantothenate, myoinositol, p-aminobenzoic acid, pyridoxine hydrochloride, riboflavin, thiamine, vitamin B12, nicotinic acid, cobalt, copper, iron, magnesium, manganese, molybdenum, nickel, selenium, zinc, potassium, or a combination thereof.

13. The oral dosage form of claim 10 , wherein the medium that lacks animal-derived components comprises cysteine.

14. The oral dosage form of claim 1 , wherein the oral dosage form is in a granule form.

15. The oral dosage form of claim 1 , wherein the oral dosage form further comprises mannitol, sucrose, or a combination thereof.

16. The oral dosage form of claim 1 , wherein the oral dosage form is administered to a subject in combination with another agent.

17. The oral dosage form of claim 16 , wherein the oral dosage form is administered simultaneously with the another agent, prior to administration of the another agent, or subsequent to administration of the another agent.

18. The oral dosage form of claim 1 , wherein the oral dosage form is formulated for administration to a subject 1, 2, 3, or more times daily.

19. The oral dosage form of claim 1 , wherein the oral dosage form is capable of increasing butyrate production in a subject.

20. The oral dosage form of claim 1 , wherein the oral dosage form is capable of altering GLP-1 production in a subject.

21. The oral dosage form of claim 1 , wherein the oral dosage form is capable of altering GPCR signaling in a subject.

22. The oral dosage form of claim 1 , wherein the microbe is capable of converting lactate, acetate, or a combination thereof into butyrate in a subject.

23. The oral dosage form of claim 1 , wherein the oral dosage form is capable of increasing glucose control, increasing insulin sensitivity, increasing weight loss, decreasing appetite, or a combination thereof in a subject.

24. The oral dosage form of claim 1 , wherein the microbe is Eubacterium hallii.

25. The oral dosage form of claim 1 , wherein the microbe is lyophilized.

26. The oral dosage form of claim 1 , wherein the oral dosage form is formulated for delivery of the microbe to an ileum region of a gastrointestinal tract, a large intestine region of the gastrointestinal tract, or a combination thereof.

27. A method of increasing insulin sensitivity, increasing glucose tolerance, treating insulin resistance, treating metabolic syndrome, or treating type 2 diabetes mellitus in a subject in need thereof, comprising administering to the subject the oral dosage form of claim 1 .

Assignments (3)
SECURITY INTEREST Recorded Jan 18, 2022
From: PENDULUM THERAPEUTICS, INC.
To: TRINITY CAPITAL INC.
Reel/Frame 058678/0276 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 20, 2020
From: CUTCLIFFE, COLLEEN; EID, JOHN S.; BULLARD, JAMES H.; SCHIKLBERGER, MARCUS F.
To: WHOLE BIOME INC.
Reel/Frame 054115/0986 →
CHANGE OF NAME Recorded Oct 20, 2020
From: WHOLE BIOME INC.
To: PENDULUM THERAPEUTICS, INC.
Reel/Frame 054156/0917 →
Cited By (3)
US 12,233,095 US 12,343,360 US 12,544,412