# US 10,245,255 B2 · Compositions and methods for the treatment of obesity and related disorders

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- Number: US 10,245,255 B2
- Document ID: US10245255B2
- Status: Granted
- Kind: B2
- Application number: 13/396,320
- Filed: 2012-02-14
- Published: 2012-08-16
- Granted: 2019-04-02
- Earliest claimed: 2011-02-14
- Assignees: The Regents of the University of Michigan
- Applicants: Alan R. Saltiel; Stuart Decker
- Inventors: Alan R. Saltiel; Stuart Decker
- Web page: https://patentgrep.com/patent/US10245255B2

## CPC

- A61K 31/436: the heterocyclic ring system containing a six-membered ring having oxygen as a ring hetero atom, e.g. rapamycin
- A61P 1/16: for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
- A61P 3/04: Anorexiants; Antiobesity agents
- A61P 3/10: for hyperglycaemia, e.g. antidiabetics
- A61P 5/48: of the pancreatic hormones
- 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

## Abstract

Provided herein are compositions and methods for the treatment of obesity and related disorders, including, but not limited to insulin resistance, diabetes, and hepatic steatosis. For example, in some embodiments, pharmaceutically acceptable compositions and methods are provided employing amlexanox, a derivative thereof, or a pharmaceutically acceptable salt thereof, alone or in combination with other agents and/or medical interventions, for the treatment, prevention, and management of such diseases and conditions.

## Claims

### Claim 1

A method of treating a human subject having a condition associated with obesity, insulin resistance, or hepatic steatosis by inhibiting TBK1 and/or IKKε consisting essentially of administering an orally effective amount of amlexanox, or a pharmaceutically acceptable salt thereof, to a human subject having a condition associated with obesity, insulin resistance, or hepatic steatosis, wherein the subject does not have an allergy, an aphthous ulcer, or bronchial asthma, and wherein the administering causes a reduction of body fat in the subject.

### Claim 2 (depends on 1)

The method of claim 1, wherein the subject has or is at risk of experiencing obesity, diabetes, or insulin resistance.

### Claim 3 (depends on 2)

The method of claim 2, wherein the diabetes is type II diabetes.

### Claim 4 (depends on 1)

The method of claim 1, wherein the treatment results in increased glucose metabolism, reduction in body fat, lack of increase in body fat, increased insulin receptor signaling, decreased level of insulin receptor phosphorylation, reduction in or prevention of chronic inflammation in the liver, reduction in or prevention of chronic inflammation in adipose tissue, reduction in or prevention of hepatic steatosis, promotion of metabolic energy expenditure, reduction in circulating free fatty acids, or reduction in cholesterol.

### Claim 5 (depends on 1)

The method of claim 1, wherein the subject has hepatic steatosis.

### Claim 6 (depends on 5)

The method of claim 5, wherein the subject also has steatohepatitis.

### Claim 7 (depends on 1)

The method of claim 1, wherein the subject is overweight or obese.

### Claim 8 (depends on 1)

The method of claim 1, wherein the subject is not in need of tissue regeneration and/or is not suffering from tissue rejection.

### Claim 9 (depends on 1)

The method of claim 1, wherein the subject does not have a cell proliferative disorder.

### Claim 10 (depends on 1)

The method of claim 1, wherein the administering comprises administering amlexanox in combination with an additional therapeutic agent or medical intervention.

### Claim 11 (depends on 1)

The method of claim 1, further comprising a step comprising testing the subject for a disease or condition selected from the group consisting of impaired insulin signaling, obesity, diabetes, insulin resistance, metabolic syndrome, hepatic steatosis, chronic liver inflammation, and chronic inflammation in adipose tissue.

### Claim 12 (depends on 11)

The method of claim 11, further comprising the step of administering a second dose of amlexanox after the testing step.

### Claim 13 (depends on 1)

The method of claim 1 wherein said orally effective amount of amlexanox, or a pharmaceutically acceptable salt thereof, is 25 mg/kg, and said subject has a condition associated with obesity.