IP Library Granted Patent US 9,060,992
Granted Patent B2
US 9,060,992 · App. 12/938,117 · Granted Jun 23, 2015

Treatment of short bowel syndrome patients with colon-in-continuity

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Quick Facts
Patent No.
US 9,060,992
App. No.
12/938,117
Granted
Jun 23, 2015
Kind
B2
Abstract

Intestinal absorption is enhanced in short bowel syndrome patients presenting with colon-in-continuity by treatment with a GLP-2 receptor agonist, such as teduglutide.

Claims (26)

1. A method for enhancing intestinal absorption in a patient with short bowel syndrome with colon-in-continuity with remnant small intestine, wherein the patient retains colon sufficient to produce at least about 10% of endogenous GLP-2 levels produced by a healthy individual in a fed state, comprising the step of administering to said patient a GLP-2 receptor agonist using a dosing regimen effective to enhance intestinal absorption, wherein said GLP-2 receptor agonist is selected from the group consisting of a GLP-2 peptide, a GLP-2 analog, a derivatized GLP-2 peptide or a derivatized GLP-2 analog.

2. The method according to claim 1 , wherein said enhancement of intestinal absorption is an increase in at least one of a wet weight absorption compared to a baseline wet weight absorption and/or an energy absorption compared to a baseline energy absorption.

3. The method according to claim 2 , wherein said patient has at least 25% colon-in-continuity with remnant small intestine.

4. The method according to claim 3 , wherein said patient has at least 50% colon-in-continuity with remnant small intestine.

5. The method according to claim 4 , wherein said patient has at least 75% colon-in-continuity with remnant small intestine.

6. The method according to claim 2 , wherein said patient has colon sufficient to produce endogenous GLP-2 plasma levels of at least 5pmol/L in the fed state.

7. The method according to claim 6 , wherein said patient has colon sufficient to produce endogenous GLP-2 plasma levels of at least 10pmol/L in the fed state.

8. The method according to claim 2 , wherein said remnant small intestine has a length of at least 25 cm.

9. The method according to claim 8 , wherein said remnant small intestine has a length of at least 50 cm.

10. The method according to claim 2 , wherein said dosing regimen comprises daily administration of said GLP-2 receptor agonist.

11. The method according to claim 2 , wherein said dosing regimen comprises administration of said GLP-2 receptor agonist over a period of at least 21 days.

12. The method according to claim 2 , wherein said GLP-2 receptor agonist is a mammalian GLP-2.

13. The method according to claim 12 , wherein said GLP-2 receptor agonist is human GLP-2.

14. The method according to claim 2 , wherein said GLP-2 receptor agonist is a GLP-2 analog.

15. The method according to claim 14 , wherein said GLP-2 receptor agonist is a human GLP-2 analog.

16. The method according to claim 15 , wherein said GLP-2 receptor agonist is [Gly2]hGLP-2.

17. The method according to claim 10 , wherein said GLP-2 receptor agonist is administered at a daily dose of from 5 to 500 μg/kg/day.

18. The method according to claim 1 , wherein the patient's short bowel syndrome is secondary to at least one of: Crohn's disease, vascular ischemic disease, mesenteric infarction, malrotation, volvulous, trauma, injury, a congenital anomaly, or a stricture.

19. The method according to claim 18 , wherein the patient's short bowel syndrome is secondary to Crohn's disease.

20. The method according to claim 18 , wherein the patient's short bowel syndrome is secondary to a stricture.

21. The method according to claim 18 , wherein the patient's short bowel syndrome is secondary to mesenteric infarction.

22. The method according to claim 18 , wherein the patient's short bowel syndrome is secondary to volvulous.

23. The method according to claim 20 , wherein the patient's short bowel syndrome is secondary to injury.

24. The method according to claim 1 , wherein the patient produces at least about 20%, 30%, 40%, or 50% of the endogenous GLP-2 plasma levels produced by a healthy individual in the fed state.

25. The method according to claim 1 , wherein the patient produces about 100% of the endogenous GLP-2 plasma levels produced by a healthy individual in the fed state.

26. A method according to claim 1 , wherein the patient produces at least about 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, or 70 pmol/L endogenous GLP-2 plasma levels in the fed state.

Assignments (5)
CHANGE OF ADDRESS Recorded Jul 19, 2018
From: SHIRE-NPS PHARMACEUTICALS, INC.
To: SHIRE-NPS PHARMACEUTICALS, INC.
Reel/Frame 046612/0867 →
CHANGE OF NAME Recorded Jan 23, 2017
From: NPS PHARMACEUTICALS, INC.
To: SHIRE-NPS PHARMACEUTICALS, INC.
Reel/Frame 041069/0700 →
CHANGE OF NAME Recorded Dec 23, 2016
From: NPS PHARMACEUTICALS, INC.
To: SHIRE-NPS PHARMACEUTICALS, INC.
Reel/Frame 041187/0545 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 9, 2016
From: SANGUINETTI, ELIZABETH L; MARRIOTT, THOMAS B; LOPANSRI, JENNIFER; BLOSCH, CONSUELO M
To: NPS ALLELIX CORP.
Reel/Frame 040268/0384 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 9, 2016
From: NPS ALLELIX CORP.
To: NPS PHARMACEUTICALS, INC.
Reel/Frame 040268/0643 →