# US 2019/0376127 A1 · Compositions and methods targeting the th2 pathway for the treatment of asthma

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- Number: US 2019/0376127 A1
- Document ID: US20190376127A1
- Status: Published application
- Kind: A1
- Application number: 16/476,703
- Filed: 2018-01-09
- Published: 2019-12-12
- Earliest claimed: 2017-01-09
- Assignees: The Children's Hospital of Philadelphia
- Applicants: The Children's Hospital of Philadelphia
- Inventors: Hakon Hakonsaron; Patrick Sleiman
- Web page: https://patentgrep.com/patent/US20190376127A1

## CPC

- A61P 11/06: Antiasthmatics
- C12Q 1/6827: for detection of mutation or polymorphism
- C12Q 1/6883: for diseases caused by alterations of genetic material
- C12Q 2600/106: Pharmacogenomics, i.e. genetic variability in individual responses to drugs and drug metabolism
- C12Q 2600/156: Polymorphic or mutational markers
- G01N 2800/122: Chronic or obstructive airway disorders, e.g. asthma COPD
- 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
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)

## Abstract

Compositions and methods for diagnosing and treating asthma and asthma patients a Th2 high asthma phenotype are disclosed.

## Claims

### Claim 1

(canceled)

### Claim 2

(canceled)

### Claim 3

A method for diagnosing a human asthma patient as having an asthma with a Th2 high molecular phenotype comprising;
a) obtaining a biological sample comprising nucleic acids from a human asthma patient; and
b) detecting in said sample, nucleic acids harboring a combination of single nucleotide polymorphisms (SNPs) selected from 1) rs2786098 and rs2014202, or 2) rs2786098 and rs7522056, detection of either combination indicating that said subject has asthma with a Th2 high molecular phenotype.

### Claim 4 (depends on 3)

The method of claim 3, further comprising detection of one or more of nucleic acids harboring single nucleotide polymorphism (SNP) having rs numbers selected from rs6673687, rs11240565, rs11240554, rs823116, rs1775146, rs1775143, rs12565321, and rs12567894.

### Claim 5

(canceled)

### Claim 6

(canceled)

### Claim 7 (depends on 3)

The method of claim 3, further comprising administering an agent that targets the Th2 inflammation pathway such as a CRTH2 inhibitor such as any one or more of the agents of Table 2.

### Claim 8

(canceled)

### Claim 9 (depends on 3)

The method of claim 3, wherein said SNP is detected by performing a process selected from detection of specific hybridization, measurement of allele size, restriction fragment length polymorphism analysis, allele-specific hybridization analysis, single base primer extension reaction, and sequencing of an amplified polynucleotide.

### Claim 10 (depends on 9)

The method as claimed in claim 9, wherein the target nucleic acid is amplified prior to detection.

### Claim 11 (depends on 3)

The method of claim 3, wherein nucleic acids comprising said polymorphism are obtained from isolated cells from the human subject.

### Claim 12

A method for treating an asthma comprising;
a) obtaining a biological sample comprising nucleic acids from a human subject, or obtaining genetic information from a human subject; and
b) detecting in said sample, or identifying in said genetic information, the presence or absence of nucleic acids harboring a combination of single nucleotide polymorphisms (SNPs) selected from 1) rs2786098 and rs2014202, or 2) rs2786098 and rs7522056; and
c) administering an agent that targets the Th2 inflammation pathway when said combination is detected.

### Claim 13 (depends on 12)

The method of claim 12, further comprising detection of one or more of nucleic acids harboring a single nucleotide polymorphism (SNP) having rs numbers selected from rs6673687, rs11240565, rs11240554, rs823116, rs1775146, rs1775143, rs12565321, and rs12567894.

### Claim 14 (depends on 13)

The method of claim 13, wherein said agent targets the Th2 inflammation pathway and is selected from CRTH2 inhibitors listed in Table 2.

### Claim 15

(canceled)

### Claim 16

(canceled)

### Claim 17

A method for treating asthma and/or treating a Th2 high molecular phenotype asthma in a human subject, comprising,
a) obtaining a biological sample comprising nucleic acids from a human subject, or obtaining genetic information relating to the subject;
b) detecting in the sample, or determining from the genetic information whether the subject has:
i) any one or more of SNPs rs2014202, rs7522056, rs6673687, rs11240565, rs11240554, rs823116, rs1775146, rs1775143, rs12565321, and rs12567894; or
ii) rs2786098 together with any one or more of SNPs: rs2014202, rs7522056, rs6673687, rs11240565, rs11240554, rs823116, rs1775146, rs1775143, rs12565321, and rs12567894; and
c) administering an effective amount of an agent that targets the Th2 inflammation pathway such as any one or more of the agents of Table 2 to the subject in subjects where i) or ii) are present subject, thereby treating asthma.

### Claim 18 (depends on 17)

The method of claim 17, wherein the subject has Th2-high asthma.

### Claim 19 (depends on 17)

The method of claim 17, wherein said agent is AP768 or AP770.

### Claim at position 20

20-21. (canceled)

### Claim 22 (depends on 3)

The method of claim 3, wherein the risk allele is detected.

### Claim 23 (depends on 17, 21)

The method of claim 17 or 21, wherein the subject has snps rs2786098 and rs7522056 and the risk allele is detected.