Claims for Patent: 11,517,564

Summary for Patent: 11,517,564

Title:	Methods of treatment for cystic fibrosis
Abstract:	Compound I of the formula (I) and/or pharmaceutically acceptable salt(s) of Compound I comprised in a pharmaceutical composition and methods of using the same to treat cystic fibrosis.
Inventor(s):	Weichao George Chen, Eric L. Haseltine, Samuel Moskowitz, Sarah Robertson, David Waltz
Assignee:	Vertex Pharmaceuticals Inc
Application Number:	US16/629,472
Patent Claims:	1. A method of treating cystic fibrosis comprising administering daily to a patient in need thereof: (a) 10 mg to 900 mg of at least one compound chosen from: (i) Compound I: and (ii) pharmaceutically acceptable salts thereof; and (b) at least one compound chosen from: (i) Compound II: (ii) Compound III or Compound III-d: (iii) Compound IV: and (iv) pharmaceutically acceptable salts of Compound II, Compound III, Compound III-d, and Compound IV. 2. The method according to claim 1, wherein the at least one compound chosen from Compound I and pharmaceutically acceptable salts thereof, is administered in a single composition with the at least one compound chosen from Compound II, Compound III, Compound III-d, Compound IV, and pharmaceutically acceptable salts thereof. 3. The method according to claim 1, wherein the at least one compound chosen from Compound I and pharmaceutically acceptable salts thereof, and the at least one compound chosen from Compound II, Compound III, Compound III-d, Compound IV, and pharmaceutically acceptable salts thereof, are administered in separate compositions. 4. The method according to claim 1, wherein 80 mg to 400 mg of at least one compound chosen from Compound I and pharmaceutically acceptable salts thereof is administered daily. 5. The method according to claim 1, wherein 200 mg of at least one compound chosen from Compound I and pharmaceutically acceptable salts thereof is administered daily. 6. The method according to claim 1, wherein the at least one compound chosen from Compound I and pharmaceutically acceptable salts thereof is administered as a single dose, once daily. 7. The method according to claim 1, wherein 25 mg to 200 mg of at least one compound chosen from Compound II and pharmaceutically acceptable salts thereof is administered daily. 8. The method according to claim 1, wherein 100 mg of at least one compound chosen from Compound II and pharmaceutically acceptable salts thereof is administered daily. 9. The method according to claim 1, wherein (i) 50 mg to 600 mg of at least one compound chosen from Compound III and pharmaceutically acceptable salts thereof is administered daily; or (ii) 50 mg to 400 mg of at least one compound chosen from Compound III-d and pharmaceutically acceptable salts thereof is administered daily. 10. The method according to claim 1, wherein: (i) 300 mg of at least one compound chosen from Compound III and pharmaceutically acceptable salts thereof is administered daily; or (ii) 150 mg of at least one compound chosen from Compound III-d and pharmaceutically acceptable salts thereof is administered daily. 11. The method according to claim 1, wherein: (i) the dose of at least one compound chosen from Compound III and pharmaceutically acceptable salts thereof is administered in two doses daily; or (ii) the dose of at least one compound chosen from Compound III-d and pharmaceutically acceptable salts thereof is administered as a single dose daily. 12. The method according to claim 1, wherein: (i) 50 mg to 200 mg of at least one compound chosen from Compound II and pharmaceutically acceptable salts thereof is administered daily; and/or 75 mg to 450 mg of at least one compound chosen from Compound III and pharmaceutically acceptable salts thereof is administered daily; or (ii) 50 mg to 200 mg of at least one compound chosen from Compound II and pharmaceutically acceptable salts thereof is administered daily; and/or 50 mg to 300 mg of at least one compound chosen from Compound III-d and pharmaceutically acceptable salts thereof is administered daily. 13. The method according to claim 1, comprising administering to the patient: (i) Compound I, Compound II, and Compound III; or (ii) Compound I, Compound II, and Compound III-d. 14. The method according to claim 1, comprising administering to the patient: (i) Compound I and Compound III; or (ii) Compound I and Compound III-d. 15. The method according to claim 1, wherein the patient is administered: (a) 200 mg of at least one compound chosen from Compound I and pharmaceutically acceptable salts thereof daily, and (b) 100 mg of at least one compound chosen from Compound II and pharmaceutically acceptable salts thereof daily, and 150 mg per dose of at least one compound chosen from Compound III and pharmaceutically acceptable salts thereof twice daily. 16. The method according to claim 1, wherein the method further comprises administering at least one additional active pharmaceutical ingredient. 17. The method according to claim 1, wherein at least one of the hydrogen atoms in at least one of Compound I, Compound II, Compound III, and Compound III-d is replaced by deuterium. 18. The method according to claim 1, wherein: (a) Compound I, Compound II, and Compound III are administered to the patient, and wherein Compound I, Compound II, and Compound III are comprised in a single pharmaceutical composition; or (b) Compound I, Compound II, and Compound III-d are administered to the patient, and wherein Compound I, Compound II, and Compound III-d are comprised in a single pharmaceutical composition. 19. A method of treating cystic fibrosis comprising administering to a patient in need thereof: 200 mg of at least one compound chosen from Compound I and pharmaceutically acceptable salts thereof once daily: and 100 mg of at least one compound chosen from Compound II and pharmaceutically acceptable salts thereof once daily: and 150 mg per dose of at least one compound chosen from Compound III and pharmaceutically acceptable salts thereof twice daily: 20. A pharmaceutical composition comprising 10 mg to 900 mg of at least one compound chosen from Compound I and pharmaceutically acceptable salts thereof. 21. The pharmaceutical composition according to claim 20, wherein the pharmaceutical composition comprises 100 mg of at least one compound chosen from Compound I and pharmaceutically acceptable salts thereof. 22. The pharmaceutical composition according to claim 20, wherein the pharmaceutical composition further comprises 25 mg to 200 mg of at least one compound chosen from Compound II and pharmaceutically acceptable salts thereof. 23. The pharmaceutical composition according to claim 20, wherein the pharmaceutical composition further comprises 50 mg of at least one compound chosen from Compound II and pharmaceutically acceptable salts thereof. 24. The pharmaceutical composition according to claim 20, wherein the pharmaceutical composition further comprises: (a) 50 mg to 600 mg of at least one compound chosen from Compound III and pharmaceutically acceptable salts thereof, or (b) 50 mg to 400 mg of at least one compound chosen from Compound III-d and pharmaceutically acceptable salts thereof. 25. The pharmaceutical composition according to claim 20, wherein the pharmaceutical composition further comprises 75 mg of at least one compound chosen from Compound III and pharmaceutically acceptable salts thereof. 26. The pharmaceutical composition according to claim 20, wherein the pharmaceutical composition further comprises 75 mg of at least one compound chosen from Compound III-d and pharmaceutically acceptable salts thereof.