Methods of selectively treating asthma using IL-13 antagonists

Patent metadata

Field	Value
Publication number	US-10066267-B2
Application number	US-201515302348-A
Country	US
Kind code	B2
Filing date	Apr 8, 2015
Priority date	Apr 11, 2014
Publication date	Sep 4, 2018
Grant date	Sep 4, 2018

Abstract

The disclosure is directed to novel predictive methods and personalized therapies for treating asthma. Specifically, this disclosure relates to methods of treating a patient having asthma by selectively administering an IL-13 antagonist, on the basis of that patient being genetically predisposed to have a favorable response to treatment with the IL-13 antagonist. Also disclosed herein are transmittable forms of information, diagnostic methods, and kits useful in predicting the likelihood that a patient having asthma will respond to treatment with an IL-13 antagonist.

First claim

What is claimed is:

1. A method of selectively treating a patient having asthma, comprising
i) measuring one or more Anti-IL-13 Response (“AIR”) markers selected from the group consisting of AIR marker 1, 2, 3, 4, 5, 6, 7, 8, and 9,
ii) diagnosing whether the patient has asthma when one or more markers is present; and
iii) thereafter administering a therapeutically effective amount of an IL-13 antagonist to the patient;
wherein said IL-13 antagonist is an antibody comprising a heavy chain as set forth in SEQ ID NO: 20 and a light chain as recited in SEQ ID NO: 18.

2. The method according to claim 1 , wherein
said measuring step comprises assaying a biological sample from the patient for the presence of at least one AIR marker selected from said group.

3. The method of claim 1 further comprising determining whether said AIR marker is present in homozygous or heterozygous form; wherein the step of diagnosing whether the patient has asthma is determined by the presence of the at least one AIR marker in homozygous form.

4. The method of claim 1 , wherein said AIR marker is selected from the group consisting of AIR marker 3 and AIR marker 7.

5. The method according to claim 2 , wherein the step of assaying comprises assaying the biological sample for a nucleic acid product of the at least one AIR marker, or a polypeptide product of the at least one AIR marker.

6. The method according to claim 2 , wherein the step of assaying comprises assaying the biological sample for a genomic sequence of the at least one AIR marker.

7. The method according to claim 2 , wherein the biological sample is selected from the group consisting of blood, serum, feces, plasma, urine, tear, saliva, and a tissue sample.

8. The method according claim 2 , wherein the step of assaying comprises a technique selected from the group consisting of Northern blot analysis, polymerase chain reaction (PCR), reverse transcription-polymerase chain reaction (RT-PCR), TaqMan-based assays, direct sequencing, dynamic allele-specific hybridization, high-density oligonucleotide SNP arrays, restriction fragment length polymorphism (RFLP) assays, primer extension assays, oligonucleotide ligase assays, analysis of single strand conformation polymorphism, temperature gradient gel electrophoresis (TGGE), denaturing high performance liquid chromatography, high-resolution melting analysis, DNA mismatch-binding protein assays, capillary electrophoresis, Southern Blot, immunoassays, immunohistochemistry, ELISA, flow cytometry, Western blot, HPLC, and mass spectrometry.

9. The method according to claim 1 , wherein said IL-13 antagonist is an antibody administered at a dose of about 50-1000 mg i.v. administered every 4 weeks.

10. The method according to claim 1 , wherein the IL-13 antagonist has a K D of about 100-200 pM.

11. The method according to claim 1 , wherein the IL-13 antagonist has an in vivo half-life of about 21 days.

Assignees

• Damask Amy
• Lewitzky Steven
• Rotte Michael
• Novartis Ag

Inventors

• Damask Amy
• Lewitzky Steven
• Rotte Michael

Classifications

• A61P11/06

  Antiasthmatics · CPC title

• C12Q2600/158

  Expression markers · CPC title

• C12Q2600/106

  Pharmacogenomics, i.e. genetic variability in individual responses to drugs and drug metabolism · CPC title

• C07K2317/76

  Antagonist effect on antigen, e.g. neutralization or inhibition of binding · CPC title

• C07K2317/34

  Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues · CPC title