Methods for Treating Disorders of the Gastrointestinal Tract Using a GLP-1 Agonist

• US 20130053316A1
• Filed: 04/08/2011
• Published: 02/28/2013
• Est. Priority Date: 04/09/2010
• Status: Active Grant

• Current Assignee: Sinai Health System
• Original Assignee: Mount Sinai Hospital (Sinai Health System)
• Inventors: Drucker, Daniel J., Baggio, Laurie Lynn
• Granted Patent: US 9,168,288 B2
• Time in Patent Office: Days
• US Class Current: 514/11.7
• CPC Class Codes: A61K 38/26 Glucagons
• CPC Class Codes: A61P 1/00 Drugs for disorders of the alimentary tract or the digestive system
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]

Abstract

The invention provides a method of treating a subject having, or at risk of developing, a condition in which functioning of the small or large intestine is impaired, enhancing functioning or preventing damage to the small or large intestine in a subject, or ameliorating inflammation of the small or large intestine in a subject, comprising administering to the subject a GLP-1 receptor agonist. A GLP-1 receptor agonist may also be provided in a pharmaceutically acceptable form in an amount effective to treat or prevent conditions of the small or large intestine. Further, pharmaceutical compositions are provided for the treatment or prevention of conditions of the small or large intestine comprising a GLP-1 receptor agonist, together with a pharmaceutically acceptable carrier, excipient or vehicle.

Claims

1. A method of treating a mammalian subject having, or at risk of developing, a condition in which functioning of the small or large intestine is impaired, enhancing functioning or preventing damage to the small or large intestine in a subject, or ameliorating inflammation of the small or large intestine in a subject, comprising administering to the subject a GLP-1 receptor agonist.

2. A method of claim 1 wherein the amount of GLP-1 receptor agonist administered is effective to proliferate the tissue of the small or large intestine or is effective to delay or prevent onset of the condition.

3. A method of claim 1, wherein the GLP-1 receptor agonist is an analog of GLP-1 having enhanced small or large intestine cell proliferating activity relative to native GLP-1.

4. A method of claim 1 wherein the amount of GLP-1 receptor agonist administered does not significantly lower blood glucose or body weight of the subject.

5. A method of claim 1 wherein the GLP-1 receptor agonist is exenatide.

6. A method of claim 5 wherein the total daily dose of exenatide in a human is less than 5 μ

g/day.

7. A method of claim 1 wherein the GLP-1 receptor agonist is liraglutide.

8. A method of claim 7 wherein the equivalent human dose of liraglutide is less than 0.3 mg/day.

9. A pharmaceutical composition for the treatment of inflammatory bowel disease comprising a GLP-1 receptor agonist having proliferative and/or anti-inflammatory and/or regenerative effects in the small or large intestine or colonic tissue, together with a pharmaceutically acceptable carrier, excipient or vehicle.

10. A pharmaceutical composition of claim 9 wherein the GLP-1 receptor agonist is in a dose which does not significantly lower blood glucose and/or body weight of the subject.

11. A pharmaceutical composition of claim 9 wherein the GLP-1 receptor agonist is exenatide in a dose of less than 10 μ

g.

12. A pharmaceutical composition of claim 9, wherein the GLP-1 receptor agonist is liraglutide in a dose of less than 0.6 mg.

13. A method of treatment comprising, delivering to the small intestine of a patient in need thereof, a pharmaceutically effective amount of a GLP-1 receptor agonist, wherein the length or weight of the small intestine is increased.

14. A method according to claim 13, wherein the GLP-1 receptor agonist is liraglutide, and wherein said agonist is administered in a dose of 50 μ

g/kg per day or less.

15. A method according to claim 13, wherein said delivering occurs without causing significant weight loss in the patient or without a significant reduction in glucose tolerance.