Treatment of metabolic disorders in equine animals

Patent metadata

Field	Value
Publication number	US-10688116-B2
Application number	US-201514672705-A
Country	US
Kind code	B2
Filing date	Mar 30, 2015
Priority date	Apr 1, 2014
Publication date	Jun 23, 2020
Grant date	Jun 23, 2020

Abstract

The present invention relates to one or more SGLT2 inhibitors or pharmaceutically acceptable forms thereof for use in the treatment and/or prevention of a metabolic disorder of an equine animal. In particular, the present invention relates to one or more SGLT2 inhibitors or a pharmaceutically acceptable form thereof for use in the treatment and/or prevention of laminitis, vascular dysfunction, hypertension, hepatic lipidosis, atherosclerosis, hyperadrenocorticism, Pituitary Pars Intermedia Dysfunction and/or Equine Metabolic Syndrome in an equine animal.

First claim

The invention claimed is:

1. A method of treating or preventing a metabolic disorder in an equine comprising administering an SGLT2 inhibitor or pharmaceutically acceptable form thereof, wherein said SGLT2 inhibitor or pharmaceutically acceptable form thereof consists of 1-cyano-2-(4-cyclopropyl-benzyl)-4-(β-D-glucopyranos-1-yl)-benzene, represented by the following formula:

wherein the metabolic disorder is one or more disorders selected from laminitis, vascular dysfunction, hypertension, hepatic lipidosis, atherosclerosis, hyperadrenocorticism, Pituitary Pars Intermedia Dysfunction and/or Equine Metabolic Syndrome.

2. The method according to claim 1 , wherein the metabolic disorder is a clinical condition or sign associated with insulin resistance or hyperinsulinaemia.

3. The method according to claim 1 , wherein the metabolic disorder is hyperinsulinemia and/or insulin resistance, and wherein said hyperinsulinemia and/or insulin resistance is associated with one or more of laminitis, vascular dysfunction, hypertension, hepatic lipidosis, atherosclerosis, hyperadrenocorticism, Pituitary Pars Intermedia Dysfunction and/or Equine Metabolic Syndrome.

4. The method according to claim 1 , wherein the equine animal is a horse or a pony.

5. The method according to claim 1 , wherein the equine animal is obese and/or exhibits regional adiposity.

6. The method according to claim 1 , wherein the composition comprises a crystalline complex of the SGLT2 inhibitor or pharmaceutically acceptable form thereof and an amino acid, and the amino acid is proline.

7. The method according to claim 1 , wherein the SGLT2 inhibitor or pharmaceutically acceptable form thereof is administered orally or parenterally.

8. The method according to claim 1 , wherein the SGLT2 inhibitor or pharmaceutically acceptable form thereof is administered orally.

9. The method according to claim 1 , wherein the SGLT2 inhibitor or pharmaceutically acceptable form thereof is administered in a range of from 0.01 to 5 mg/kg body weight per day.

10. The method according to claim 1 , wherein the SGLT2 inhibitor or pharmaceutically acceptable form thereof is administered in a range of from 0.02 to 1.0 mg/kg body weight per day.

11. The method according to claim 1 , wherein the SGLT2 inhibitor or pharmaceutically acceptable form thereof is administered in a range of from 0.03 to 0.4 mg/kg body weight per day.

12. The method according to claim 1 , wherein the SGLT2 inhibitor or pharmaceutically acceptable form thereof is administered once per day.

13. The method according to claim 1 , wherein the equine animal is not obese and/or is present with muscle wasting and/or exhibits hyperglycemia.

14. The method of claim 1 , wherein the composition comprises a 1:1:1 crystalline complex of the SGLT2 inhibitor or pharmaceutically acceptable form thereof, L-proline and water in a crystalline form.

15. The method according to claim 14 , wherein the 1:1:1 crystalline complex is characterized by an X-ray powder diffraction pattern that comprises peaks at 20.28, 21.14 and 21.64 degrees 2Θ (±0.1 degrees 2Θ), wherein said X-ray powder diffraction pattern is made using CuK α1 radiation.

16. The method of claim 1 , wherein said laminitis, vascular dysfunction, hypertension, hepatic lipidosis, atherosclerosis, hyperadrenocorticism, Pituitary Pars Intermedia Dysfunction and/or Equine Metabolic Syndrome is associated with insulin resistance and/or hyperinsulinemia.

Assignees

• Boehringer Ingelheim Vetmedica Gmbh

Inventors

• Reiche Dania Birte
• Mohren Nicole
• Johnston Laura
• Somerville Bruce
• Voth Rebecca K

Classifications

• A61P5/00

  Drugs for disorders of the endocrine system · CPC title

• A61P9/00

  Drugs for disorders of the cardiovascular system · CPC title

• A61K31/381

  having five-membered rings · CPC title

• A61K31/351

  not condensed with another ring · CPC title

• A61P1/16

  for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics · CPC title