IP Library › Granted Patent US 12,558,353
Granted Patent B2
US 12,558,353 · App. 18/390,000 · Granted Feb 24, 2026

Method of reducing pulmonary exacerbations in respiratory disease patients

Inventors: Sanjeev Ahuja (Carmel, IN); Ralph Grosswald (Alpharetta, GA); Gregory S. Duncan (Atlanta, GA); Eric B. Springman (Punta Gorda, FL)
Assignee: Celltaxis, LLC
A61K31/4985A61K31/47A61K31/519A61P11/00A61K45/06A61K2121/00
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Quick Facts
Patent No.
US 12,558,353
App. No.
18/390,000
Granted
Feb 24, 2026
Kind
B2
Abstract

Described are methods of reducing pulmonary exacerbations and methods of treating cystic fibrosis, including methods of reducing pulmonary inflammation, comprising administration of an LTA4h inhibitor.

Claims (15)

1 . A method of reducing pulmonary exacerbations in a cystic fibrosis patient, wherein the patient has a FEV 1 pp greater than or equal to about 68% at baseline, the method comprising orally administering to the patient acebilustat at a total daily dose of about 100 mg or less.

2 . The method of claim 1 , wherein the patient has a FEV 1 pp greater than or equal to about 70% at baseline.

3 . The method of claim 1 , wherein the acebilustat is administered at a total daily dose of about 100 mg.

4 . The method of claim 1 , wherein the acebilustat is administered at a total daily dose from about 50 to about 100 mg.

5 . The method of claim 1 , wherein the patient is concomitantly treated with an additional therapeutic agent.

6 . The method of claim 5 , wherein the additional therapeutic agent is selected from the group consisting of a mucolytic, a bronchodilator, an antibiotic, an anti-infective agent, a CFTR modulator, and an anti-inflammatory agent.

7 . The method of claim 6 , wherein the additional therapeutic agent is a CFTR modulator.

8 . The method of claim 7 , wherein the CFTR modulator is a CFTR potentiator and/or a CFTR corrector.

9 . The method of claim 1 , wherein the patient is not undergoing concomitant treatment with a CFTR potentiator and/or a CFTR corrector.

10 . The method of claim 1 , wherein the patient experiences a decrease in the rate, number, or frequency of pulmonary exacerbations in the twelve month period after initiating treatment with acebilustat.

11 . The method of claim 10 , wherein the patient does not experience a pulmonary exacerbation for at least forty-eight weeks after initiating treatment with acebilustat.

12 . The method of claim 1 , wherein the patient experiences a decreased number of pulmonary exacerbations in the twelve month period after initiating treatment with acebilustat as compared to the number of pulmonary exacerbations in the twelve month period prior to initiating treatment with acebilustat.

13 . A method of reducing pulmonary exacerbations in a cystic fibrosis patient, comprising measuring FEV 1 pp in the patient at baseline, and orally administering acebilustat at a total daily dose of about 100 mg or less to the patient that has an FEV 1 pp greater than or equal to about 68% at baseline.

14 . The method of claim 13 , wherein the patient has an FEV1pp greater than or equal to about 70% at baseline.

15 . The method of claim 13 , wherein the patient is concomitantly treated with a CFTR modulator.

Continuity (5)
Continuation 17145586 · Jan 11, 2021
Continuation 16427571 · May 31, 2019
Provisional Application 62702038 · Jul 23, 2018
Provisional Application 62678964 · May 31, 2018
Related Publication 20240358699A1 · Oct 31, 2024
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