Methods of treatment for cystic fibrosis

Patent metadata

Field	Value
Publication number	US-2020138798-A1
Application number	US-201816629472-A
Country	US
Kind code	A1
Filing date	Jul 17, 2018
Priority date	Jul 17, 2017
Publication date	May 7, 2020
Grant date	—

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.

First claim

1 . A method of treating cystic fibrosis comprising administering to a patient in need thereof:
(a) 10 mg to 900 mg of at least one compound chosen from Compound I:

and pharmaceutically acceptable salts thereof daily; and
(b) at least one compound chosen from (i) Compound II:

(ii) Compound III or Compound III-d:

and
(iii) Compound IV:

and pharmaceutically acceptable salts of any of the foregoing.

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 a pharmaceutical composition comprising at least one compound chosen from Compound I and pharmaceutically acceptable salts thereof is administered in combination with a second pharmaceutical composition comprising at least one compound chosen from Compound II, Compound III, Compound III-d, Compound IV, and pharmaceutically acceptable salts thereof.

5 . The method according to claim 1 , comprising administering to said patient: (a) at least one compound chosen from Compound I and pharmaceutically acceptable salts thereof, (b) at least one compound chosen from Compound II and pharmaceutically acceptable salts thereof, (c) and at least one compound chosen from (i) Compound III and pharmaceutically acceptable salts thereof, or (ii) Compound III-d and pharmaceutically acceptable salts thereof.

6 . The method according to claim 1 , comprising administering to said patient: (a) at least one compound chosen from Compound I and pharmaceutically acceptable salts thereof, (b) at least one compound chosen from (i) Compound III and pharmaceutically acceptable salts thereof, or (ii) Compound III-d and pharmaceutically acceptable salts thereof, and (c) at least one compound chosen from Compound IV and pharmaceutically acceptable salts thereof.

7 . The method of according to claim 1 , comprising administering to said patient: (a) at least one compound chosen from Compound I and pharmaceutically acceptable salts thereof, and at least one compound chosen from Compound II and pharmaceutically acceptable salts thereof, (bi) at least one compound chosen from Compound I and pharmaceutically acceptable salts thereof, and at least one compound chosen from Compound III and pharmaceutically acceptable salts thereof, (c) at least one compound chosen from Compound I and pharmaceutically acceptable salts thereof, and at least one compound chosen from Compound III-d and pharmaceutically acceptable salts thereof, or (d) at least one compound chosen from Compound I and pharmaceutically acceptable salts thereof, and at least one compound chosen from Compound IV and pharmaceutically acceptable salts thereof.

8 . The method according to any one of claims 1 - 7 , wherein 80 mg to 400 mg of at least one compound chosen from Compound I and pharmaceutically acceptable salts thereof is administered daily.

9 . The method according to any one of claims 1 - 7 , wherein 120 mg to 240 mg of at least one compound chosen from Compound I and pharmaceutically acceptable salts thereof is administered daily.

10 . The method according to any one of claims 1 - 7 , wherein 160 mg to 320 mg of at least one compound chosen from Compound I and pharmaceutically acceptable salts thereof is administered daily.

11 . The method according to any one of claims 1 - 7 , wherein 80 mg to 360 mg of at least one compound chosen from Compound I and pharmaceutically acceptable salts thereof is administered daily.

12 . The method according to any one of claims 1 - 7 , wherein 50 mg of at least one compound chosen from Compound I and pharmaceutically acceptable salts thereof is administered daily.

13 . The method according to any one of claims 1 - 7 , wherein 100 mg of at least one compound chosen from Compound I and pharmaceutically acceptable salts thereof is administered daily.

14 . The method according to any one of claims 1 - 7 , wherein 200 mg of at least one compound chosen from Compound I and pharmaceutically acceptable salts thereof is administered daily.

15 . The method according to any one of claims 1 - 7 , wherein 50, mg, 80 mg, 100 mg, 120 mg, 150 mg, 200 mg, 250 mg, 300 mg, 350 mg, 400 mg, 450 mg, 500 mg, 550 mg, or 600 mg of at least one compound chosen from Compound I and pharmaceutically acceptable salts thereof is administered daily.

16 . The method according to any one of claims 1 - 15 , wherein at least one compound chosen from Compound I and pharmaceutically acceptable salts thereof is administered as a single dose, once daily.

17 . The method according to any one of claims 1 - 15 , wherein at least one compound chosen from Compound I and pharmaceutically acceptable salts thereof is administered in two doses daily.

18 . The method according to any one of claims 1 - 5 , and 7 - 17 , wherein 25 mg to 200 mg of at least one compound chosen from Compound II and pharmaceutically acceptable salts thereof is administered daily.

19 . The method according to any one of claims 1 - 5 , and 7 - 17 , wherein 50 mg to 150 mg of at least one compound chosen from Compound II and pharmaceutically acceptable salts thereof is administered daily.

20 . The method according to any one of claims 1 - 5 , and 7 - 17 , wherein 50 mg of at least one compound chosen from Compound II and pharmaceutically acceptable salts thereof is administered daily.

21 . The method according to any one of claims 1 - 5 , and 7 - 17 , wherein 100 mg of at least one compound chosen from Compound II and pharmaceutically acceptable salts thereof is administered daily.

22 . The method according to any one of claims 1 - 5 , and 7 - 21 , wherein at least one compound chosen from Compound II and pharmaceutically acceptable salts thereof is administered as a single dose, once daily.

23 . The method according to any one of claims 1 - 5 , and 7 - 21 , wherein at least one compound chosen from Compound II and pharmaceutically acceptable salts thereof is administered in two doses daily.

24 . The method according to any one of claims 1 - 23 , 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.

25 . The method according to any one of claims 1 - 23 , wherein (i) 50 mg to 450 mg of at least one compound chosen from Compo

Assignees

• Vertex Pharma

Inventors

• Chen Weichao George
• Haseltine Eric L
• Moskowitz Samuel
• Robertson Sarah
• Waltz David

Classifications

• A61K31/4439 Primary

  containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole (nicotine A61K31/465) · CPC title

• A61P11/00

  Drugs for disorders of the respiratory system · CPC title

• A61K31/47

  Quinolines; Isoquinolines · CPC title

• A61K31/404

  Indoles, e.g. pindolol · CPC title

• A61K31/443

  containing a five-membered ring with oxygen as a ring hetero atom · CPC title