IP Library Granted Patent US 10,561,690
Granted Patent B2
US 10,561,690 · App. 16/211,684 · Granted Feb 18, 2020

Methods for treating ulcerative colitis

Inventor: Thomas J. Borody (Five Dock, AU)
Assignee: Crestovo Holdings LLC
A61K35/74A61K35/37A61K35/741A61P1/04A61K2035/11A61K2035/115
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Quick Facts
Patent No.
US 10,561,690
App. No.
16/211,684
Granted
Feb 18, 2020
Kind
B2
Abstract

The present disclosure provides methods and treatment regimens for treating ulcerative colitis in a subject in need thereof. In particular, the methods described herein comprise treating a subject in need thereof with a treatment regimen comprising the administration of a pharmaceutical composition comprising live non-pathogenic fecal bacteria for at least 8 weeks and at least three times per week. In an aspect, the subject in need thereof exhibits a Mayo endoscopy score of 3 or lower. In some aspects, the subject in need thereof has no concomitant corticosteroid use during said method and has no corticosteroid use immediately prior to commencing said method.

Claims (31)

1. A method for treating ulcerative colitis (UC) in a subject in need thereof comprising treating the subject with a treatment regimen comprising the oral or rectal administration of a pharmaceutical composition comprising viable non-pathogenic fecal bacteria comprising Clostridium and Ruminococcus for at least 1 week and at least twice per week, and wherein the fecal bacteria are from a stool sample of one or more human donors having no history or current symptoms of gastrointestinal disease.

2. The method of claim 1 , wherein the treatment regimen comprises the oral administration of the pharmaceutical composition.

3. The method of claim 2 , wherein the treatment regimen comprises administering the pharmaceutical composition for at least 2 weeks.

4. The method of claim 3 , wherein the treatment regimen comprises administering the pharmaceutical composition at least three times per week.

5. The method of claim 2 , wherein the viable non-pathogenic fecal bacteria further comprises Blautia, Dorea , or both.

6. The method of claim 2 , wherein the viable non-pathogenic fecal bacteria further comprises Blautia.

7. The method of claim 2 , wherein the viable non-pathogenic fecal bacteria further comprises Dorea.

8. The method of claim 2 , wherein the viable non-pathogenic fecal bacteria comprise cultured bacteria.

9. The method of claim 2 , wherein the viable non-pathogenic fecal bacteria are live fecal bacteria.

10. The method of claim 2 , wherein the viable non-pathogenic fecal bacteria are in a spore form.

11. The method of claim 2 , wherein the viable non-pathogenic fecal bacteria comprise a microbiota of a stool of a donor having no history or current symptoms of gastrointestinal disease.

12. The method of claim 2 , wherein the viable non-pathogenic fecal bacteria are from multiple donors having no history or current symptoms of gastrointestinal disease.

13. The method of claim 2 , wherein the method further comprises determining the level of one or more bacteria selected from the group consisting of Fusobacterium, Sutterella, Barnesiella, Parabacteroides, Clostridium IV, Ruminococcus, Blautia, Dorea, Ruminococcus 2, and Clostridium XVIII in the subject's gut.

14. A method for treating ulcerative colitis (UC) in a subject in need thereof comprising treating the subject with a treatment regimen comprising the oral or rectal administration of a pharmaceutical composition comprising viable non-pathogenic fecal bacteria from at least two genera selected from the group consisting of Clostridium, Ruminococcus, Blautia , and Dorea , for at least 1 week and at least twice per week, wherein the subject has no concomitant corticosteroid use during the method and wherein the subject has no steroid use within at least one week prior to commencing the method, and wherein the fecal bacteria are from a stool sample of one or more human donors having no history or current symptoms of gastrointestinal disease.

15. The method of claim 14 , wherein the treatment regimen comprises the oral administration of the pharmaceutical composition.

16. The method of claim 15 , wherein the treatment regimen comprises administering the pharmaceutical composition for at least 2 weeks.

17. The method of claim 16 , wherein the treatment regimen comprises administering the pharmaceutical composition at least three times per week.

18. The method of claim 15 , wherein the viable non-pathogenic fecal bacteria comprises Blautia, Dorea , or both.

19. The method of claim 15 , wherein the viable non-pathogenic fecal bacteria comprises Blautia.

20. The method of claim 15 , wherein the viable non-pathogenic fecal bacteria comprises Clostridium, Blautia , and Dorea.

21. The method of claim 15 , wherein the viable non-pathogenic fecal bacteria comprise cultured bacteria.

22. The method of claim 15 , wherein the viable non-pathogenic fecal bacteria are live fecal bacteria.

23. The method of claim 15 , wherein the viable non-pathogenic fecal bacteria are in a spore form.

24. The method of claim 15 , wherein the viable non-pathogenic fecal bacteria comprise a microbiota of a stool of a donor having no history or current symptoms of gastrointestinal disease.

25. The method of claim 15 , wherein the viable non-pathogenic fecal bacteria are from multiple donors having no history or current symptoms of gastrointestinal disease.

26. The method of claim 15 , wherein the method further comprises determining the level of one or more bacteria selected from the group consisting of Fusobacterium, Sutterella, Barnesiella, Parabacteroides, Clostridium IV, Ruminococcus, Blautia, Dorea, Ruminococcus 2, and Clostridium XVIII in the subject's gut.

27. The method of claim 15 , wherein the viable non-pathogenic fecal bacteria comprise Clostridium, Ruminococcus, Blautia , and Dorea.

28. The method of claim 15 , wherein the composition is administered daily for at least 1 week.

29. The method of claim 16 , wherein the composition is administered daily for at least 2 weeks.

30. The method of claim 2 , wherein the composition is administered daily for at least 1 week.

31. The method of claim 3 , wherein the composition is administered daily for at least 2 weeks.

Assignments (4)
CHANGE OF NAME Recorded Dec 31, 2020
From: CRESTOVO HOLDINGS LLC
To: FINCH THERAPEUTICS HOLDINGS LLC
Reel/Frame 054883/0280 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 10, 2020
From: BORODY, THOMAS
To: CRESTOVO HOLDINGS LLC
Reel/Frame 054608/0365 →
RELEASE OF SECURITY INTEREST Recorded Sep 5, 2019
From: CRESTOVO INVESTOR LLC; M3 VENTURES - FINCH II LLC; AVENIR FINCH INVESTORS LLC; FLIGHT PARTNERS MANAGEMENT LLC; NATIONAL PHILANTHROPIC TRUST; 91313 INVESTMENT HOLDING I LLC; SILAS HOLDING I LLC; BEE HILL HOLDINGS LLC; GORMAN, DYLAN; CHOI, KENNETH S.
To: CRESTOVO HOLDINGS LLC
Reel/Frame 050274/0530 →
SECURITY INTEREST Recorded Mar 7, 2019
From: CRESTOVO HOLDINGS LLC
To: CRESTOVO INVESTOR LLC; M3 VENTURES - FINCH II LLC; AVENIR FINCH INVESTORS, LLC; FLIGHT PARTNERS MANAGEMENT LLC; NATIONAL PHILANTHROPIC TRUST; 91313 INVESTMENT HOLDINGS LLC; SILAS HOLDINGS LLC; BEE HILL HOLDINGS LLC; GORMAN, DYLAN; CHOI, KENNETH S.
Reel/Frame 050111/0166 →
Continuity (4)
Continuation 15791868 · Oct 24, 2017
Continuation PCTUS2017045092 · Aug 2, 2017
Provisional Application 62370508 · Aug 3, 2016
Related Publication 20190175665A1 · Jun 13, 2019
Cited By (2)
US 12,390,496 US 12,496,318