Granted Patent
B2
US 12,496,305 · App. 16/940,568 · Granted Dec 16, 2025
Detection for determining corticosteroid responsiveness
Inventors:
Nima Sharifi (Shaker Heights, OH); Joe G. Zein (Mayfield Heights, OH); Benjamin Gaston (Gates Mills, OH)
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Abstract
The present invention relates to methods, kits, and compositions for testing a sample from a subject with asthma to determine: i) if the subject is A/A or A/C at position 1245 in the HSD3B1 gene, and/or if the subject expresses a 367N version of the 3β-HSD1 protein (e.g., and should be administered a non-corticosteroid for their asthma), or ii) if the subject is C/C at position 1245 in the HSD3B1 gene, and/or if the subject expresses only the 367T version of the 3β-HSD1 protein (e.g., and should be administered a corticosteroid for their asthma). In certain embodiments, the corticosteroid is a glucocorticoid.
Claims (15)
1 . A method comprising:
a) obtaining a sample from a Caucasian human subject with severe asthma,
b) testing said sample from said subject to determine:
i) said subject is C/C at position 1245 in the HSD3B1 gene, and/or
ii) said subject expresses only the 367T version of the 3β-HSD1 protein, and
c) treating said subject orally and/or by inhalation with a glucocorticoid.
2 . The method of claim 1 , wherein said sample comprises a sample type selected from: urine, saliva, serum, plasma, tissue biopsy, and whole blood.
3 . A method comprising:
a) receiving and/or reviewing a report that a Caucasian subject with severe asthma that has not been diagnosed with any other chronic pulmonary disorder is C/C at position 1245 in the HSD3B1 gene and/or expresses only a 367T version of said 3β-HSD1 protein; and
b) treating said subject orally and/or by inhalation with a glucocorticoid.
4 . The method of claim 3 , wherein said report indicates that said subject is C/C at position 1245 in the HSD3B1 gene.
5 . The method of claim 3 , wherein said report indicates that said subject only expresses a 367T version of said 3β-HSD1 protein.
6 . The method of claim 3 , wherein said glucocorticoid is an inhaled glucocorticoid.
7 . The method of claim 6 , wherein said inhaled glucocorticoid comprises fluticasone at over 440 micrograms per day.
8 . The method of claim 3 , wherein said glucocorticoid is selected from the group consisting of: hydrocortisone, prednisone, prednisolone, and dexamethasone.
Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Jan 22, 2021
From: SHARIFI, NIMA; ZEIN, JOE
To: THE CLEVELAND CLINIC FOUNDATION
Reel/Frame 055001/0440 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Jan 22, 2021
From: GASTON, BEN
To: CASE WESTERN RESERVE UNIVERSITY
Reel/Frame 055001/0530 →
CONFIRMATORY LICENSE
Recorded Aug 3, 2020
From: CLEVELAND CLINIC FOUNDATION
To: NATIONAL INSTITUTES OF HEALTH (NIH), U.S. DEPT. OF HEALTH AND HUMAN SERVICES (DHHS), U.S. GOVERNMENT
Reel/Frame 053379/0047 →
Continuity (2)
Provisional Application
62880426
· Jul 30, 2019
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