# US 10,869,861 B2 · Nonselective metabotropic glutamate receptor activators for treatment of attention deficit disorder and 22Q syndrome

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- Number: US 10,869,861 B2
- Document ID: US10869861B2
- Status: Granted
- Kind: B2
- Application number: 15/850,307
- Filed: 2017-12-21
- Published: 2018-04-26
- Granted: 2020-12-22
- Earliest claimed: 2015-09-08
- Assignees: The Children's Hospital of Philadelphia
- Applicants: The Children's Hospital of Philadelphia
- Inventors: Hakon Hakonarson; Charlly Kao
- Web page: https://patentgrep.com/patent/US10869861B2

## CPC

- A61K 31/454: containing a five-membered ring with nitrogen as a ring hetero atom, e.g. pimozide, domperidone
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61P 25/00: Drugs for disorders of the nervous system
- A61P 25/22: Anxiolytics
- C12Q 1/6883: for diseases caused by alterations of genetic material
- C12Q 2600/156: Polymorphic or mutational markers
- C12Q 2600/158: Expression markers
- 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
- C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES

## Abstract

This application relates to methods of treating attention deficit hyperactivity disorder (ADHD), 22q deletion and/or duplication syndrome, and co-morbidities with a nonselective activator of metabotropic glutamate receptors, such as fasoracetam, for example, in subjects having a genetic alteration in at least one metabotropic glutamate receptor (mGluR) network gene.

## Claims

### Claim 1

A method of treating 22q deletion syndrome comprising: administering an effective amount of fasoracetam to a subject with 22q deletion syndrome and ADHD, thereby treating the 22q deletion syndrome, wherein symptoms of impulsiveness, hyperactivity, and/or inattentiveness are reduced in the subject following administration of fasoracetam wherein the fasoracetam is administered at a dose of 50-400 mg once, twice, or three times daily.

### Claim 2 (depends on 1)

The method of claim 1, wherein the subject has a copy number variation (CNV) in RANBP1.

### Claim 3 (depends on 2)

The method of claim 2, wherein the subject has a deletion at 22q11.2.

### Claim 4 (depends on 1)

The method of claim 1, wherein the subject is a pediatric or adolescent subject.

### Claim 5 (depends on 1)

The method of claim 1, wherein the fasoracetam is fasoracetam monohydrate.

### Claim 6 (depends on 1)

The method of claim 1, wherein the fasoracetam is administered at a dose of 200-400 mg twice daily.

### Claim 7 (depends on 1)

The method of claim 1, wherein the fasoracetam is administered at a dose of 100-200 mg twice daily.

### Claim 8

A method of treating 22q deletion syndrome comprising: administering an effective amount of fasoracetam to a subject with 22q deletion syndrome and ADHD, thereby treating the 22q deletion syndrome, wherein symptoms of impulsiveness, hyperactivity, and/or inattentiveness are reduced in the subject following administration of fasoracetam, wherein the fasoracetam is administered in an amount effective to result in a clinical general impression improvement (CGI-I) score of 1 or 2 after four weeks of treatment and/or an improvement of at least 25% in an ADHD rating scale score after four weeks of treatment.

### Claim 9

A method of treating 22q deletion syndrome comprising: administering an effective amount of fasoracetam to a subject with 22q deletion syndrome and ADHD, thereby treating the 22q deletion syndrome, wherein symptoms of impulsiveness, hyperactivity, and/or inattentiveness are reduced in the subject following administration of fasoracetam, wherein the fasoracetam is administered in an amount effective to result in an improvement of at least 40% in an ADHD rating scale score after four weeks of treatment.

### Claim 10 (depends on 1)

The method of claim 1, wherein the subject has at least one CNV in a metabotropic glutamate receptor (mGluR) network gene.