# US 10,946,001 B2 · Treatment of autoimmune diseases with combinations of RXR agonists and thyroid hormones

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- Number: US 10,946,001 B2
- Document ID: US10946001B2
- Status: Granted
- Kind: B2
- Application number: 16/083,799
- Filed: 2016-10-31
- Published: 2019-12-19
- Granted: 2021-03-16
- Earliest claimed: 2016-03-10
- Assignees: Io Therapeutics, Inc.
- Applicants: Io Therapeutics, Inc.
- Inventors: Roshantha A. Chandraratna; Martin E. Sanders
- Web page: https://patentgrep.com/patent/US10946001B2

## CPC

- A61K 31/4418: having a carbocyclic group directly attached to the heterocyclic ring, e.g. cyproheptadine
- A61K 31/192: having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid {(cannabinoids A61K31/658)}
- A61K 31/198: Alpha-amino acids, e.g. alanine or edetic acid [EDTA] (betaine A61K31/205; proline A61K31/401; tryptophan A61K31/405; histidine A61K31/4172; peptides not degraded to individual amino acids A61K38/00)
- A61K 31/216: of acids having aromatic rings, e.g. benactizyne, clofibrate
- A61P 37/00: Drugs for immunological or allergic disorders
- A61K 9/0043: {Nose}
- A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration}
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- Y02A 50/30: Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
- 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
- Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE

## Abstract

The present specification provides methods of treating autoimmune diseases with a combination of a RXR agonist and a thyroid hormone.

## Claims

### Claim 1

A method of treating an autoimmune disease, wherein the autoimmune disease is an arthritis, the method comprising administering, to an individual in need thereof, a therapeutically effective amount of a RXR agonist and a thyroid hormone, wherein the RXR agonist has the structure of Formula II
wherein R is H or lower alkyl of 1 to 6 carbons; or a pharmaceutically acceptable salt thereof;
wherein administration of the RXR agonist and the thyroid hormone treats the autoimmune disease in the individual more effectively than either the RXR agonist or the thyroid hormone alone.

### Claim 2 (depends on 1)

The method according to claim 1, wherein is the RXR agonist is a selective RXR agonist comprising 3,7-dimethyl-6(S),7(S)-methano,7-[1,1,4,4-tetramethyl-1,2,3,4-tetrahydronaphth-7-yl]2(E),4(E) heptadienoic acid.

### Claim 3 (depends on 1)

The method according to claim 1, wherein the RXR agonist is 3,7-dimethyl-6(S),7(S)-methano,7-[1,1,4,4-tetrahydronaphth-7-yl]2(E),4(E) heptadienoic ethyl ester.

### Claim 4 (depends on 1)

The method according to claim 1, wherein the thyroid hormone is thyroxine.

### Claim 5 (depends on 1)

The method according to claim 1, wherein the therapeutically effective amount of an ester of the RXR agonist having the structure of Formula II is about 0.001 mg/day to about 1000 mg/day.

### Claim 6 (depends on 1)

The method according to claim 1, wherein the therapeutically effective amount of the RXR agonist is about 0.001 mg/day to about 1000 mg/day.

### Claim 7 (depends on 1)

The method according to claim 1, wherein the therapeutically effective amount of the RXR agonist is about 1 mg/day to about 100 mg/day.

### Claim 8 (depends on 4)

The method according to either claim 4, wherein the therapeutically effective amount of the thyroxine is about 12.5 μg/day to about 250 μg/day.

### Claim 9 (depends on 1)

The method according to claim 1, wherein the RXR agonist is administered by nasal administration.

### Claim 10 (depends on 4)

The method according to claim 4, wherein the RXR agonist and thyroxine are both administered by nasal administration.

### Claim 11 (depends on 1)

The method according to claim 1, wherein the RXR agonist is administered orally.

### Claim 12 (depends on 4)

The method according to claim 4, wherein the RXR agonist and the thyroxine are both administered substantially simultaneously.

### Claim 13 (depends on 4)

The method according to claim 4, wherein the RXR agonist and the thyroxine are administered on different schedules.

### Claim 14 (depends on 4)

The method according to claim 4, wherein the thyroxine is administered orally.

### Claim 15 (depends on 4)

The method according to claim 4, wherein the thyroxine is administered subcutaneously.

### Claim 16 (depends on 1)

The method according to claim 1, wherein the arthritis is psoriatic arthritis.

### Claim 17 (depends on 1)

The method according to claim 1, wherein the arthritis is monoarthritis, oligoarthritis, polyarthritis, osteoarthritis, rheumatoid arthritis, juvenile idiopathic arthritis, septic arthritis, spondyloarthropathy, gout, pseudogout, or Still's disease.

### Claim 18 (depends on 1)

The method according to claim 1, wherein the arthritis is rheumatoid arthritis.

### Claim 19

A method of treating an autoimmune disease, wherein the autoimmune disease is an arthritis, the method comprising of administering, to an individual in need thereof, a therapeutically effective amount of a combination of 3,7-dimethyl-6(S),7(S)-methano,7-[1,1,4,4-tetramethyl-1,2,3,4-tetrahydronaphth-7-yl]2(E),4(E) heptadienoic acid (IRX4204), and thyroxine; and wherein administration of the combination reduces severity of the autoimmune disease in the individual more effectively than either the IRX4204 or the thyroxine alone.