# US 11,433,045 B2 · Treatment of metabolic disorders in canine animals

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- Number: US 11,433,045 B2
- Document ID: US11433045B2
- Status: Granted
- Kind: B2
- Application number: 16/790,810
- Filed: 2020-02-14
- Published: 2020-06-11
- Granted: 2022-09-06
- Earliest claimed: 2014-01-23
- Applicants: Boehringer Ingelheim Vetmedica GmbH
- Inventors: Saskia Kley; Dania Reiche
- Web page: https://patentgrep.com/patent/US11433045B2

## CPC

- A61K 31/351: not condensed with another ring
- A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration}
- A61K 9/02: Suppositories; Bougies; Bases therefor; {Ovules}(apparatus for making A61J3/08; devices for introducing into the body A61M31/00)
- A61K 9/08: Solutions {(composition of solutions A61K47/00)}
- A61K 9/145: {with organic compounds}
- A61K 9/2009: {Inorganic compounds}
- A61K 9/2013: {Organic compounds, e.g. phospholipids, fats}
- A61K 9/2018: {Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates}
- A61K 9/2027: {obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates}
- A61K 9/2059: {Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin}
- A61K 9/4825: {Proteins, e.g. gelatin (gelatin capsule shells with substantial amounts of other macromolecular substances A61K9/4816)}
- A61K 9/4858: {Organic compounds}
- A61K 9/4866: {Organic macromolecular compounds}
- A61K 31/00: Medicinal preparations containing organic active ingredients
- A61K 31/401: Proline; Derivatives thereof, e.g. captopril
- A61K 31/7028: Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages
- A61K 31/7034: attached to a carbocyclic compound, e.g. phloridzin
- A61K 31/7042: Compounds having saccharide radicals and heterocyclic rings
- A61K 31/7056: containing five-membered rings with nitrogen as a ring hetero atom
- A61K 38/28: Insulins
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61K 47/22: Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
- A61P 1/16: for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
- A61P 1/18: for pancreatic disorders, e.g. pancreatic enzymes
- A61P 3/00: Drugs for disorders of the metabolism (of the blood or the extracellular fluid A61P7/00)
- A61P 3/04: Anorexiants; Antiobesity agents
- A61P 3/06: Antihyperlipidemics
- A61P 3/10: for hyperglycaemia, e.g. antidiabetics
- A61P 5/50: for increasing or potentiating the activity of insulin
- A61P 7/00: Drugs for disorders of the blood or the extracellular fluid
- A61P 9/12: Antihypertensives
- A61P 13/12: of the kidneys
- A61P 19/00: Drugs for skeletal disorders
- A61P 21/00: Drugs for disorders of the muscular or neuromuscular system
- A61P 27/02: Ophthalmic agents
- A61P 27/12: for cataracts
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61P 31/12: Antivirals
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- C07D 309/10: Oxygen atoms
- C07D 493/08: Bridged systems
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- C07D: HETEROCYCLIC COMPOUNDS (macromolecular compounds C08)

## 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 in a canine animal, preferably wherein the metabolic disorder is one or more selected from the group consisting of: ketoacidosis, pre-diabetes, insulin dependent diabetes mellitus, insulin resistance diabetes, insulin resistance, obesity, hyperglycemia, hyperglycemia induced cataract formation, impaired glucose tolerance, hyperinsulinemia, dyslipidemia, dysadipokinemia, subclinical inflammation, systemic inflammation, low grade systemic inflammation, hepatic lipidosis, inflammation of the pancreas, metabolic disorder consequences, such as hypertension, renal dysfunction and/or muscoskeletal disorders, and/or Syndrome X (metabolic syndrome), wherein preferably the development of hyperglycemia induced cataract formation is prevented or remission is achieved and/or wherein preferably the development of metabolic disorder consequences, such as hypertension, renal dysfunction and/or muscoskeletal disorders, is prevented or progression is slowed or remission is achieved.

## Claims

### Claim 1

A method of treatment of a metabolic disorder in a canine animal comprising administering to the canine animal a composition comprising one or more active agents, where the one or more active agents consist of one or more SGLT2 inhibitors or pharmaceutically acceptable forms thereof;
wherein:
the one or more SGLT-2 inhibitors or pharmaceutically acceptable forms thereof comprises 1-cyano-2-(4-cyclopropyl-benzyl)-4-(β-D-glucopyranos-1-yl)-benzene or a pharmaceutically acceptable form thereof represented by the following formula:
the metabolic disorder is one or more selected from the group consisting of ketoacidosis, pre-diabetes, insulin dependent diabetes mellitus, insulin resistance diabetes, insulin resistance, obesity, hyperglycemia, hyperglycemia induced cataract formation, impaired glucose tolerance, hyperinsulinemia, dyslipidemia, dysadipokinemia, subclinical inflammation, systemic inflammation, low grade systemic inflammation, hepatic lipidosis, inflammation of the pancreas, metabolic disorder consequences comprising hypertension, renal dysfunction and/or musculoskeletal disorders, and Syndrome X (metabolic syndrome); and
the one or more SGLT-2 inhibitors or pharmaceutically acceptable forms thereof is administered at a dose of no greater than 2.0 mg/kg bodyweight.

### Claim 2 (depends on 1)

The method of claim 1, wherein the development of hyperglycemia induced cataract formation is prevented or remission is achieved and/or the development of metabolic disorder consequences prevented or progression is slowed or remission is achieved.

### Claim 3 (depends on 1)

The method of claim 1, wherein the metabolic disorder is selected from the group consisting of clinical conditions associated with pre-diabetes, insulin dependent diabetes mellitus and insulin resistance.

### Claim 4 (depends on 3)

The method of claim 3, wherein the clinical conditions are one or more conditions selected from the group consisting of ketoacidosis, insulin resistance, obesity, hyperglycemia, hyperglycemia induced cataract formation, impaired glucose tolerance, hyperinsulinemia, dyslipidemia, dysadipokinemia, subclinical inflammation, systemic inflammation, low grade systemic inflammation, hepatic lipidosis, inflammation of the pancreas, metabolic disorder consequences comprising hypertension, renal dysfunction and/or musculoskeletal disorders, and Syndrome X (metabolic syndrome).

### Claim 5 (depends on 1)

The method of claim 1, wherein the canine animal is suffering from diabetes.

### Claim 6 (depends on 1)

The method of claim 1, wherein the canine animal is suffering from pre-diabetes or insulin dependent diabetes.

### Claim 7 (depends on 1)

The method of claim 1, wherein the canine animal is a dog.

### Claim 8 (depends on 1)

The method of claim 1, wherein the pharmaceutically acceptable form thereof is a crystalline complex between the one or more SGLT-2 inhibitors and one or more amino acids.

### Claim 9 (depends on 8)

The method of claim 8, wherein the one or more amino acids comprise proline.

### Claim 10 (depends on 8)

The method of claim 8, wherein the one or more amino acids comprise L-proline.

### Claim 11 (depends on 1)

The method of claim 1, wherein the one or more SGLT-2 inhibitors or pharmaceutically acceptable forms thereof is administered orally or parenterally.

### Claim 12 (depends on 1)

The method of claim 1, wherein the one or more SGLT-2 inhibitors or pharmaceutically acceptable forms thereof is administered once per day.

### Claim 13 (depends on 1)

The method of claim 1, wherein the one or more SGLT-2 inhibitors or pharmaceutically acceptable forms thereof is administered at a dose of 0.01 to 1.0 mg/kg bodyweight.