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Last Updated: April 24, 2024

Details for Patent: 9,545,434


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Title:Treatment of short bowel syndrome patients with colon-in-continuity
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.
Inventor(s): Sanguinetti; Elizabeth L. (Salt Lake City, UT), Marriott; Thomas B. (Sandy, UT), Lopansri; Jennifer (Park City, UT), Blosch; Consuelo M. (Seattle, WA)
Assignee: NPS PHARMACEUTICALS, INC. (Bedminster, NJ)
Filing Date:Jun 19, 2015
Application Number:14/745,157
Claims:1. A method for treating a patient with short bowel syndrome with colon-in-continuity with remnant small intestine, the method comprising: administering to the patient an amount of a GLP-2 receptor agonist that is effective to reduce intestinal wet weight excretion in the patient, wherein the GLP-2 receptor agonist is selected from the group consisting of a GLP-2 peptide, a GLP-2 analog, a derivatized GLP-2 peptide, and a derivatized GLP-2 analog.

2. The method of claim 1, wherein the reduction in intestinal wet weight excretion is a decrease in fecal wet weight excretion.

3. The method of claim 1, wherein the patient has at least 25% colon-in-continuity with remnant small intestine.

4. The method of claim 1, wherein the patient has at least 50% colon-in-continuity with remnant small intestine.

5. The method of claim 1, wherein the patient has at least 75% colon-in-continuity with remnant small intestine.

6. The method of claim 1, wherein the patient has colon sufficient to produce endogenous GLP-2 plasma levels of at least 5 pmol/L in the fed state.

7. The method of claim 1, wherein the patient has colon sufficient to produce endogenous GLP-2 plasma levels of at least 10 pmol/L in the fed state.

8. The method of claim 1, wherein the remnant small intestine has a length of at least 25 cm.

9. The method of claim 1, wherein the remnant small intestine has a length of at least 50 cm.

10. The method of claim 1, wherein the GLP-2 receptor agonist is administered at least daily.

11. The method of claim 1, wherein the GLP-2 receptor agonist is administered at least twice daily.

12. The method of claim 1, wherein the GLP-2 receptor agonist is administered over a period of at least 21 days.

13. The method of claim 1, wherein the GLP-2 receptor agonist is administered via injection or infusion.

14. The method of claim 13, wherein injection is selected from the group consisting of subcutaneous injection, intramuscular injection, intravenous injection, and depot injection.

15. The method of claim 1, wherein the GLP-2 receptor agonist is a mammalian GLP-2 peptide.

16. The method of claim 15, wherein the mammalian GLP-2 is human GLP-2 peptide.

17. The method of claim 1, wherein the GLP-2 receptor agonist is a GLP-2 analog.

18. The method of claim 17, wherein the GLP-2 analog is a human GLP-2analog.

19. The method of claim 1, wherein the GLP-2 receptor agonist is [Gly2]hGLP-2.

20. The method of claim 1, wherein the patient's short bowel syndrome is secondary to one or more conditions selected from the group consisting of Crohn's disease, vascular ischemic disease, mesenteric infarction, malrotation, volvulous, trauma, injury, a congenital anomaly, a stricture, and any combinations thereof.

21. The method of claim 1, wherein the patient has had a small bowel resection prior to the treatment.

22. The method of claim 1, wherein the patient is dependent on parenteral support.

23. The method of claim 1, wherein the GLP-2 receptor agonist is [Gly2]hGLP-2, wherein the patient has at least 25% colon-in-continuity with remnant small intestine, wherein the patient has colon sufficient to produce endogenous GLP-2 plasma levels of at least 5 pmol/L in the fed state and wherein the amount of the GLP-2 receptor agonist is at least 0.10 mg/kg/d.

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