# US 12,005,044 B1 · Treatment of autism spectrum disorders with ergothioneine, selenoneine, or combinations thereof

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- Number: US 12,005,044 B1
- Document ID: US12005044B1
- Status: Granted
- Kind: B1
- Application number: 18/071,344
- Filed: 2022-11-29
- Published: 2024-06-06
- Granted: 2024-06-11
- Earliest claimed: 2022-11-29
- Assignees: Autism Therapeutics Inc.
- Applicants: Autism Therapeutics Inc.
- Inventors: Dexian Dou
- Web page: https://patentgrep.com/patent/US12005044B1

## CPC

- A61K 31/4172: Imidazole-alkanecarboxylic acids, e.g. histidine
- A61K 31/555: containing heavy metals, e.g. hemin, hematin, melarsoprol
- A61P 25/00: Drugs for disorders of the nervous system
- A61P 25/18: Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
- 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

A method of treatment of autism spectrum disorders comprising ergothioneine (ET), selenoneine (SeET), or combinations thereof. The methods may include the use of edible compositions comprising ergothioneine (ET), selenoneine (SeET), or combinations thereof.

## Claims

### Claim 1

A method of treatment of autism spectrum disorders comprising:
administering a therapeutically effective amount of ergothioneine (ET) without other active ingredients in a dosage range of from about 0.1 to about 75 mg/kg body weight (bw) per day for at least one month to a human subject;
wherein a CARS 2 score of the human subject is reduced by at least one point.

### Claim 2 (depends on 1)

The method of claim 1, wherein the ergothioneine (ET) is administered in the form of powders, tablets, capsules, drinks, or other edible forms.

### Claim 3 (depends on 2)

The method of claim 2, wherein the ergothioneine (ET) is administered in a dosage range of from about 0.01 to about 17,600 mg daily.

### Claim 4 (depends on 1)

The method of claim 1, wherein the ergothioneine (ET) is administered in a dosage range of from about 0.07 to about 12,000 mg daily.

### Claim 5 (depends on 2)

The method of claim 2, wherein the ergothioneine (ET) is administered in a dosage range of from about 1 to about 1000 mg daily.

### Claim 6 (depends on 2)

The method of claim 2, wherein the administration occurs daily for a period of at least three months.

### Claim 7 (depends on 1)

The method of claim 1, wherein the administration occurs daily for a period of at least six months.

### Claim 8 (depends on 1)

The method of claim 1, wherein the administration occurs daily for a period of at least one year, or even at least 5 years.

### Claim 9 (depends on 1)

The method of claim 1, comprising administering ergothioneine (ET) in a dosage range of from about 0.2 to about 20 mg/kg body weight (bw) per day.

### Claim 10 (depends on 2)

The method of claim 2, comprising administering ergothioneine (ET) in a dosage range of from about 1 to about 5 mg/kg body weight (bw) per day.

### Claim 11 (depends on 6)

The method of claim 6, comprising administering ergothioneine (ET) in a dosage range of from about 10 to about 1000 mg per day.

### Claim 12 (depends on 1)

The method of claim 1, comprising administering ergothioneine (ET) in a dosage range of from about 20 to about 500 mg per day.

### Claim 13 (depends on 1)

The method of claim 1, wherein the CARS-2 score of the human subject is reduced by at least 2, or even at least 5.

### Claim 14 (depends on 1)

The method of claim 1, include administering ergothioneine (ET) in a dosage range of 20 mg per day or more, 35 mg per day or more, 40 mg per day or more, or 50 mg per day or more.

### Claim 15

A method of treatment of autism spectrum disorders comprising administering a therapeutically effective amount of ergothioneine (ET) and optionally selenoneine (SeET) to a human subject;
wherein the therapeutically effective amount of ergothioneine (ET) and optionally selenoneine (SeET)-is administered in a dosage range of from about 0.45 μg to about 800 mg/kg body weight (bw) per day; and
wherein a CARS-2 score of the human subject is reduced by at least 1.5.

### Claim 16 (depends on 15)

The method of claim 15, wherein the administration occurs daily for a period of at least three months.

### Claim 17 (depends on 15)

The method of claim 15, wherein the administration occurs daily for a period of at least six months.

### Claim 18 (depends on 15)

The method of claim 15, wherein the administration occurs daily for a period of at least one year, or even at least 5 years.

### Claim 19 (depends on 15)

The method of claim 15, wherein the CARS-2 score of the human subject is reduced by at least 2.

### Claim 20 (depends on 15)

The method of claim 15, wherein the CARS-2 score of the human subject is reduced by at least 5.