TREATMENT OF SHORT BOWEL SYNDROME PATIENTS WITH COLON-IN-CONTINUITY

• US 20170020965A1
• Filed: 10/05/2016
• Published: 01/26/2017
• Est. Priority Date: 11/01/2004
• Status: Active Grant

• Current Assignee: Shire-NPS Pharmaceuticals, Inc. (Shire plc)
• Original Assignee: NPS Pharmaceuticals Incorporated (Shire plc)
• Inventors: Sanguinetti, Elizabeth L., Marriott, Thomas B., Lopansri, Jennifer, Blosch, Consuelo M.
• Granted Patent: US 9,981,014 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 5/4222 Evaluating particular parts, e.g. particular organs
• CPC Class Codes: A61K 38/26 Glucagons
• CPC Class Codes: A61K 9/0019 Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner non-active ingredients are additionally classified in A61K47/00
• CPC Class Codes: A61P 1/00 Drugs for disorders of the alimentary tract or the digestive system
• CPC Class Codes: A61P 1/02 Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis

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

1. A method for treating a patient with short bowel syndrome presenting with colon-in-continuity with remnant small intestine, said method comprising administering to the patient h(Gly2)GLP-2 using a dosing regimen effective to enhance intestinal absorption by the patient.

2. A method as defined in claim 1, wherein the dosing regimen comprises daily administration of said (Gly2)hGLP-2.

3. A method as defined in claim 2, wherein the h(Gly2)GLP-2 is administered at a daily dose of from 5 to 500 μ

g/kg.

4. A method as defined in claim 3, wherein the h(Gly2)GLP-2 is administered at a daily dose of from 30 to 150 μ

g/kg.

5. A method as defined in claim 1, wherein the h(Gly2)GLP-2 is administered by subcutaneous injection.

6. A method as defined in claim 5, wherein the subcutaneous injection is into the abdomen, thigh, or arm.

7. A method as defined in claim 1, wherein the intestinal absorption is enhanced by an increase in wet weight absorption of at least 750 mL/day compared to a baseline wet weight absorption.

8. A method as defined in claim 1, wherein the patient is an adult.

9. A method as defined in claim 1, wherein the patient is dependent on parenteral nutrition.

18. A method as defined in claim 1, wherein said regimen comprises administration of said h(Gly2)GLP-2 over a period of at least 21 days.

21. A method as defined in claim 1, wherein said patient is an adult and the h(Gly2)GLP-2 is administered at a daily dose of from 30 to 150 μ

g/kg by subcutaneous injection.

10. A method for treating a patient with short bowel syndrome presenting with colon-in-continuity with remnant small intestine, said method comprising administering to the patient h(Gly2)GLP-2 using a dosing regimen effective to enhance intestinal absorption by the patient;

wherein the h(Gly2)GLP-2 is administered daily at a dose of from 30 to 150 μ

g/kg by subcutaneous injection into the abdomen, thigh, or arm of said patient.

11. A method as defined in claim 10, wherein the intestinal absorption is enhanced by an increase in wet weight absorption of at least 750 mL/day compared to a baseline wet weight absorption.

12. A method as defined in claim 10, wherein the patient is an adult who is dependent on parenteral nutrition.

17. A method as defined in claim 10, wherein the intestinal absorption is enhanced by an increase in wet weight absorption of at least 750 mL/day compared to a baseline wet weight absorption.

19. A method as defined in claim 10, wherein said regimen comprises administration of said h(Gly2)GLP-2 over a period of at least 21 days.

13. A method for treating a patient with short bowel syndrome who is dependent on parenteral nutrition and is presenting with colon-in-continuity with remnant small intestine, said method comprising administering to the patient h(Gly2)GLP-2 using a dosing regimen effective to enhance intestinal absorption by the patient.

14. A method as defined in claim 13, wherein the GLP-2 receptor agonist is administered daily at a dose of from 30 to 150 μ

g/kg.

15. A method as defined in claim 13, wherein the GLP-2 receptor agonist is administered by subcutaneous injection.

16. A method as defined in claim 13, wherein the patient is an adult.

20. A method as defined in claim 13, wherein said regimen comprises administration of said h(Gly2)GLP-2 over a period of at least 21 days.

22. A method as defined in claim 13, wherein said patient is an adult and the h(Gly2)GLP-2 is administered at a daily dose of from 30 to 150 μ

g/kg by subcutaneous injection.