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

• US 9,545,435 B1
• Filed: 10/05/2016
• Issued: 01/17/2017
• 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.
• Primary Examiner(s): Gudibande, Satyanarayana R
• Application Number:
  US15/285,852
• Publication Number:
  US 20170020973A1
• Time in Patent Office: 104 Days
• Field of Search: None
• 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 of treating a patient having short bowel syndrome with congenital intestinal abnormalities, who receives parenteral nutrition each week, and who presents with colon-in-continuity with remnant small intestine, said method comprising administering [Gly2]hGLP-2 to said patient using a dosing regimen effective to reduce or eliminate said weekly parenteral nutrition received by said patient.

2. The method as defined in claim 1, wherein the [Gly2]hGLP-2 is administered at a daily dose of from 5 to 500 μ

g/kg.

3. The method as defined in claim 2, wherein the [Gly2]hGLP-2 is administered at a daily dose of from 30 to 150 μ

g/kg.

4. The method as defined in claim 1, wherein the [Gly2]hGLP-2 is administered by subcutaneous injection.

5. The method as defined in claim 4, wherein the subcutaneous injection is into the abdomen, thigh, or arm.

6. The method as defined in claim 1, wherein the patient is an adult.

13. The method as defined in claim 1, wherein said regimen comprises administration of said [Gly2]hGLP-2 over a period of at least 21 days.

15. The method as defined in claim 1, wherein the parenteral nutrition is reduced by volume or frequency of administration.

16. The method as defined in claim 1, wherein said patient is an adult and the [Gly2]hGLP-2 is administered at a daily dose of from 30 to 150 μ

g/kg by subcutaneous injection.

7. A method of treating a patient having short bowel syndrome with congenital intestinal abnormalities, who receives parenteral nutrition each week, and who presents with colon-in-continuity with remnant small intestine, said method comprising administering [Gly2]hGLP-2 to said patient using a dosing regimen effective to increase wet weight absorption compared to a baseline wet weight absorption by said patient.

8. The method as defined in claim 7, wherein the [Gly2]hGLP-2 is administered at a daily dose of from 5 to 500 μ

g/kg.

9. The method as defined in claim 8, wherein the [Gly2]hGLP-2 is administered at a daily dose of from 30 to 150 μ

g/kg.

10. The method as defined in claim 7, wherein the [Gly2]hGLP-2 is administered by subcutaneous injection.

11. The method as defined in claim 10, wherein the subcutaneous injection is into the abdomen, thigh, or arm.

12. The method as defined in claim 7, wherein the patient is an adult.

14. The method as defined in claim 7, wherein said regimen comprises administration of said [Gly2]hGLP-2 over a period of at least 21 days.

17. The method as defined in claim 7, wherein said patient is an adult and the [Gly2]hGLP-2 is administered at a daily dose of from 30 to 150 μ

g/kg by subcutaneous injection.