Method of treatment and compositions comprising a dual PI3K delta-gamma kinase inhibitor and a corticosteroid
This present disclosure relates to a method of treating autoimmune, respiratory and/or inflammatory diseases or conditions, e.g., asthma, COPD, rheumatoid arthritis and idiopathic Pulmonary Fibrosis (IPF). The method comprises administering a dual PI3K delta and gamma inhibitor and a corticosteroid. The present invention also relates to pharmaceutical compositions containing a dual PI3K delta and gamma inhibitor and a corticosteroid.
1. A method of treating a respiratory disease or condition selected from asthma, allergic rhinitis and chronic obstructive pulmonary disease, the method comprising administering to a subject in need thereof a therapeutically effective amount of (i) a dual PI3K delta and gamma inhibitor of formula A:
or a pharmaceutically acceptable salt thereof, and (ii) mometasone furoate, fluticasone, fluticasone propionate, or a pharmaceutically acceptable salt thereof.
2. The method according to claim 1 , wherein the therapeutically effective amount of (i) the dual PI3K delta and gamma inhibitor, and the therapeutically effective amount of (ii) the mometasone furoate, fluticasone, fluticasone propionate, or a pharmaceutically acceptable salt thereof are administered simultaneously as a combined formulation.
3. The method according to claim 1 , wherein the therapeutically effective amount of (i) the dual PI3K delta and gamma inhibitor, and the therapeutically effective amount of (ii) the mometasone furoate, fluticasone, fluticasone propionate, or a pharmaceutically acceptable salt thereof are administered sequentially.
4. The method according to claim 3 , wherein the therapeutically effective amount of the mometasone furoate, fluticasone, fluticasone propionate, or a pharmaceutically acceptable salt thereof is administered before the therapeutically effective amount of the dual PI3K delta and gamma inhibitor.
5. The method according to claim 1 , wherein the therapeutically effective amount of the dual PI3K delta and gamma inhibitor is administered twice daily to once every three weeks, and the therapeutically effective amount of the mometasone furoate, fluticasone, fluticasone propionate, or a pharmaceutically acceptable salt thereof is administered twice daily to once every three weeks.
6. The method according to claim 1 , wherein the dual PI3K delta and gamma inhibitor and the mometasone furoate, fluticasone, fluticasone propionate, or a pharmaceutically acceptable salt thereof are each administered in an amount ranging from about 0.01 mg to about 1000 mg.
7. The method of claim 1 , wherein the dual PI3K delta and gamma inhibitor and the mometasone furoate, fluticasone, fluticasone propionate, or a pharmaceutically acceptable salt thereof are administered at a ratio of about 1:100 to about 100:1 by weight.
8. The method according to claim 1 , wherein the respiratory disease or condition is asthma.
9. The method according to claim 1 , wherein the respiratory disease or condition is allergic rhinitis.
10. The method according to claim 1 , wherein the respiratory disease or condition is chronic obstructive pulmonary disease.
11. The method of claim 1 , wherein the method comprises administering a therapeutically effective amount of (i) a dual PI3K delta and gamma inhibitor of formula A:
or a pharmaceutically acceptable salt thereof, and (ii) mometasone furoate or a pharmaceutically acceptable salt thereof.
12. The method of claim 11 , wherein the method comprises administering a therapeutically effective amount of (i) a dual PI3K delta and gamma inhibitor of formula A:
or a pharmaceutically acceptable salt thereof, and (ii) mometasone furoate.
13. The method of claim 1 , wherein the method comprises administering a therapeutically effective amount of (i) a dual PI3K delta and gamma inhibitor of formula A:
or a pharmaceutically acceptable salt thereof, and (ii) fluticasone or a pharmaceutically acceptable salt thereof.
14. The method of claim 13 , wherein the method comprises administering a therapeutically effective amount of (i) a dual PI3K delta and gamma inhibitor of formula A:
or a pharmaceutically acceptable salt thereof, and (ii) fluticasone.
15. The method of claim 1 , wherein the method comprises administering a therapeutically effective amount of (i) a dual PI3K delta and gamma inhibitor of formula A:
or a pharmaceutically acceptable salt thereof, and (ii) fluticasone propionate or a pharmaceutically acceptable salt thereof.
16. The method of claim 15 , wherein the method comprises administering a therapeutically effective amount of (i) a dual PI3K delta and gamma inhibitor of formula A:
or a pharmaceutically acceptable salt thereof, and (ii) fluticasone propionate.
17. The method according to claim 11 , wherein the respiratory disease or condition is asthma.
18. The method according to claim 11 , wherein the respiratory disease or condition is allergic rhinitis.
19. The method according to claim 11 , wherein the respiratory disease or condition is chronic obstructive pulmonary disease.
20. A method of treating a respiratory disease or condition selected from asthma, allergic rhinitis and chronic obstructive pulmonary disease, the method comprising intranasally administering to a subject in need thereof a therapeutically effective amount of (i) a dual PI3K delta and gamma inhibitor of formula A:
or a pharmaceutically acceptable salt thereof, and (ii) mometasone furoate or a pharmaceutically acceptable salt thereof.
21. The method according to claim 20 , wherein the respiratory disease or condition is asthma.
22. The method according to claim 20 , wherein the respiratory disease or condition is allergic rhinitis.
23. The method according to claim 20 , wherein the respiratory disease or condition is chronic obstructive pulmonary disease.
24. A method of treating a respiratory disease or condition selected from asthma, allergic rhinitis and chronic obstructive pulmonary disease, the method comprising intranasally administering to a subject in need thereof a therapeutically effective amount of (i) a dual PI3K delta and gamma inhibitor of formula A:
or a pharmaceutically acceptable salt thereof, and (ii) fluticasone or a pharmaceutically acceptable salt thereof.
25. The method according to claim 24 , wherein the respiratory disease or condition is asthma.
26. The method according to claim 24 , wherein the respiratory disease or condition is allergic rhinitis.
27. The method according to claim 24 , wherein the respiratory disease or condition is chronic obstructive pulmonary disease.
28. A method of treating a respiratory disease or condition selected from asthma, allergic rhinitis and chronic obstructive pulmonary disease, the method comprising intranasally administering to a subject in need thereof a therapeutically effective amount of (i) a dual PI3K delta and gamma inhibitor of formula A:
or a pharmaceutically acceptable salt thereof, and (ii) fluticasone propionate or a pharmaceutically acceptable salt thereof.
29. The method according to claim 28 , wherein the respiratory disease or condition is asthma.
30. The method according to claim 28 , wherein the respiratory disease or condition is allergic rhinitis.
31. The method according to claim 28 , wherein the respiratory disease or condition is chronic obstructive pulmonary disease.