IP Library › Granted Patent US 10,758,534
Granted Patent B2
US 10,758,534 · App. 16/258,024 · Granted Sep 1, 2020

Modulators of cystic fibrosis transmembrane conductance regulator

Inventors: Mark Thomas Miller (San Diego, CA); Corey Anderson (San Diego, CA); Vijayalaksmi Arumugam (San Marcos, CA); Brian Richard Bear (Carlsbad, CA); Hayley Marie Binch (Encinitas, CA); Jeremy J. Clemens (San Diego, CA); Thomas Cleveland (San Diego, CA); Erica Conroy (Columbus, OH); Timothy Richard Coon (Carlsbad, CA); Bryan A. Frieman (La Jolla, CA); Peter Diederik Jan Grootenhuis (San Diego, CA); Raymond Stanley Gross (Poway, CA); Sara Sabina Hadida-Ruah (La Jolla, CA); Haripada Khatuya (San Diego, CA); Pramod Virupax Joshi (San Diego, CA); Paul John Krenitsky (San Diego, CA); Chun-Chieh Lin (San Diego, CA); Gulin Erdogan Marelius (San Diego, CA); Vito Melillo (Escondido, CA); Jason McCartney (Cardiff by the Sea, CA); Georgia McGaughey Nicholls (Winchester, MA); Fabrice Jean Denis Pierre (La Jolla, CA); Alina Silina (San Diego, CA); Andreas P. Termin (Encinitas, CA); Johnny Uy (San Diego, CA); Jinglan Zhou (San Diego, CA)
Assignee: Vertex Pharmaceuticals Incorporated
A61K31/506A61J1/035A61K31/404A61K31/415A61K31/44A61K31/444A61K31/4418A61K31/4439A61K31/4525A61K31/4545A61K31/4709A61K31/496A61K31/497C07D209/18C07D209/42C07D209/49C07D213/64C07D213/73C07D213/82C07D213/84C07D231/12C07D231/14C07D231/20C07D235/24C07D239/34C07D401/04C07D401/12C07D401/14C07D403/10C07D403/12C07D405/14C07D407/12C07D413/14C07D417/12
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Quick Facts
Patent No.
US 10,758,534
App. No.
16/258,024
Granted
Sep 1, 2020
Kind
B2
Abstract

The present invention features a compound of formula I: or a pharmaceutically acceptable salt thereof, where R 1 , R 2 , R 3 , W, X, Y, Z, n, o, p, and q are defined herein, for the treatment of CFTR mediated diseases, such as cystic fibrosis. The present invention also features pharmaceutical compositions, method of treating, and kits thereof.

Claims (101)

1. A compound of formula Ib-iii:

or a pharmaceutically acceptable salt thereof, wherein:

Ring B is a C6-C10 aryl ring or C3-C10 heteroaryl or heterocyclic ring wherein anywhere from 1 to 4 ring atoms are independently O, S, N, or NR;

Ring C is a C3-C14 heteroaryl or heterocyclic ring wherein anywhere from 1 to 4 ring atoms are independently N, O, or S, and wherein one nitrogen on Ring C is the point of attachment to the pyridine ring;

and wherein, independently for each occurrence:

R 1 is halo; CN; F 5 S; SiR 3 ; OH; NRR; C1-C6 alkyl or fluoroalkyl; C1-C6 alkoxy or fluoroalkoxy; C1-C6 alkenyl; C1-C6 alkynyl; (C1-C9 alkylene)-R 4 wherein up to four CH 2 units are independently replaced with O, CO, S, SO, SO 2 or NR; C6-C10 aryl; C3-C10 heteroaryl or heterocyclic ring wherein anywhere from 1 to 4 ring atoms are independently O, S, N, or NR; or C3-C10 cycloalkyl;

R 2 is halo; OH; NRR; azide; CN; CO 2 R; C1-C6 alkyl or fluoroalkyl; C1-C6 alkoxy or fluoroalkoxy; C1-C6 alkenyl; C1-C6 alkynyl; C6-C10 aryl; C3-C13 heteroaryl or heterocyclic ring wherein anywhere from 1 to 4 ring atoms are independently O, S, N, or NR; C3-C10 cycloalkyl; or a (C1-C9 alkylene)-R 4 wherein up to four CH 2 units are independently replaced with O, CO, S, SO, SO 2 or NR;

or two R 2 groups taken together may form a=CH 2 or ═O group;

R 3 is halo; CN; CO 2 R; C1-C6 alkyl or fluoroalkyl; C1-C6 alkenyl; C1-C6 alkynyl; C1-C6 alkoxy or fluoroalkoxy; or C6-C10 aryl; C3-C10 heteroaryl or heterocyclic ring wherein anywhere from 1 to 4 ring atoms are independently O, S, N, or NR; C3-C10 cycloalkyl; or a (C1-C9 alkylene)-R 4 wherein up to four CH 2 units are independently replaced with O, CO, S, SO, SO 2 or NR;

or two R 3 groups taken together may form a=CH 2 or ═O group;

R 4 is H; azide; CF 3 ; CHF 2 ; OR; CCH; CO 2 R; OH; C6-C10 aryl, C3-C10 heteroaryl or heterocycloalkyl wherein anywhere from 1 to 4 ring atoms are independently O, S, N, or NR; C3-C10 cycloalkyl; NRR, NRCOR, CONRR, CN, halo, or SO 2 R;

R is independently H; OH; CO 2 H; CO 2 C1-C6 alkyl; C1-C6 alkyl; C1-C6 alkenyl; C1-C6 alkynyl; C6-C10 aryl; C3-C10 heteroaryl or heterocycloalkyl wherein anywhere from 1 to 4 ring atoms are independently O, S, N, or NR; or C3-C10 cycloalkyl;

n is 0, 1, 2 or 3;

p is 0, 1, 2, or 3; and

q is 0, 1, 2, 3, 4, or 5.

2. The compound or salt of claim 1 , wherein ring B is phenyl, pyridyl, pyridine-2(1H)-one, pyrazole, indole, aza-indole, thiophene, dihydrobenzofuran, or quinoline.

3. The compound or salt of claim 1 , wherein ring B is selected from

4. The compound or salt of claim 1 , wherein ring C is selected from indole, piperidine, azepane, azetadine, indoline, isoindoline, or pyrrolidine.

5. The compound or salt of claim 1 , wherein ring C is selected from

6. The compound or salt of claim 1 , wherein R 1 is halo, CN, C1-C6 alkyl, C1-C6 alkoxy, C3-C8 cycloalkyl, or a phenyl, pyridyl, pyrimidine, indole, aza-indole, pyrazole, or thiophene ring, or a (C1-C9 alkylene)-R 4 wherein up to four CH 2 units are independently replaced with O, CO, S, SO, SO 2 or NR, wherein all rings are optionally substituted with one or more groups selected from halo, C1-C6 alkyl, C1-C6 alkoxy, C1-C6 fluoroalkyl, C1-C6 fluoroalkoxy, OH, CH 2 OH, CH 2 OCH 3 , CN, CO 2 H, amino, amido, C3-C10 heteroaryl, and C3-C10 heterocycloalkyl.

7. The compound or salt of claim 1 , wherein R 1 is selected from CH 3 , Cl, F, CN, OCH 3 , CF 3 , CH 2 CH 3 , tBu, CH(CH 3 ) 2 , OCH 2 CH 2 OCH 2 CH 3 ,

8. The compound or salt of claim 1 , wherein R 2 is selected from halo, OH, CN, azide, amino, C1-C6 alkyl or fluoroalkyl, C1-C6 alkoxy or fluoroalkoxy, C3-C10 heterocyclic ring wherein up to 4 ring atoms are independently 0, S, N, or NR; or a (C1-C9 alkylene)-R 4 wherein up to four CH 2 units are independently replaced with O, CO, S, SO, SO 2 or NR.

9. The compound or salt of claim 1 , wherein R 2 is selected from Cl, F, OH, CN, N 3 , NH 2 , NH(CH 3 ), N(CH 3 ) 2 , N(CH 3 )CH 2 CH 2 CH 3 , N(CH 3 )CH 2 CH 2 CH 2 CH 3 , CH 3 , CH 2 OH, CH 2 CH 3 , CH 2 CH 2 CH 3 , =O, CH 3 SO 2 , CH 3 SO 2 NH, CF 3 CONH, CH 3 CONH, CH 3 CON(CH 3 ), tBuOCONH, (CH 3 ) 2 CHOCONH, CH(CH 3 ) 2 , CHF 2 , OCH 3 , OCH 2 CH 3 , OCH 2 CH 2 CH 3 , OCH 2 CH 2 CH(CH 3 ) 2 , OCF 3 , OCHF 2 , OC(CH 3 ) 3 , OCH 2 CH 2 tBu, NHCH(CH 3 )(CH 2 CH 2 CH 3 ), OCH(CH 3 ) 2 , NH(CH 2 ) 2 O(CH 2 ) 2 CH 3 , C(O)CH 3 , CH 2 CH 2 OH, CH 2 NH 2 , NH(CH 2 ) 2 OH, N(CH 3 )CH 2 CH 2 CH 2 OCH 3 , NHCH 2 CH 2 COOH, NH(CH 2 ) 2 N(CH 3 ) 2 , NH(CH 2 ) 2 NH 2 , NH(CH 2 ) 3 NH 2 , NH(CH 2 ) 2 OCH 3 , NHCH(CH 3 ) 2 ,

10. The compound or salt of claim 1 , wherein R 3 is selected from halo, CN, C1-C6 alkyl or fluoroalkyl, C1-C6 alkoxy, or C3-C10 heteroaryl wherein anywhere from 1 to 4 ring atoms are independently O, S, N, or NR.

11. The compound or salt of claim 1 , wherein R 3 is selected from Cl, I, deuterium, F, CN, CH 3 , OH, OCH 3 , CF 3 , CH 2 CH 3 , CH 2 CF 3 , CH 2 CH 2 CH 3 , OCH 2 CH(CH 3 ) 2 , OCH(CH 3 ) 2 , CO 2 H, CO 2 NH 2 , OCH 2 CH 3 , CH 2 OCH 3 , CH(CH 3 ) 2 , CCH, CH 2 CONH 2 , CO 2 CH 3 , —CH 2 N(CH 3 ) 2 , CO 2 tBu, tBu, =CH 2 , =O,

12. A compound of formula Ib-iv:

or a pharmaceutically acceptable salt thereof, wherein, independently for each occurrence:

Ring B is a C6-C10 aryl ring or C3-C10 heteroaryl or heterocyclic ring wherein anywhere from 1 to 4 ring atoms are independently O, S, N, or NR;

Ring C is a C3-C14 heteroaryl or heterocyclic ring wherein anywhere from 1 to 4 ring atoms are independently N, O, or S, and wherein one nitrogen on Ring C is the point of attachment to the pyridine ring;

R 1 is C6-C10 aryl or C3-C10 heteroaryl wherein anywhere from 1 to 4 ring atoms are independently O, S, N, or NR;

R 2 is halo; OH; NRR; azide; CN; CO 2 R; C1-C6 alkyl or fluoroalkyl; C1-C6 alkoxy or fluoroalkoxy; C1-C6 alkenyl; C1-C6 alkynyl; C6-C10 aryl; C3-C13 heteroaryl or heterocyclic ring wherein anywhere from 1 to 4 ring atoms are independently O, S, N, or NR; C3-C10 cycloalkyl; or a (C1-C9 alkylene)-R 4 wherein up to four CH 2 units are independently replaced with O, CO, S, SO, SO 2 or NR;

or two R 2 groups taken together may form a=CH 2 or ═O group;

R 3 is halo; CN; CO 2 R; C1-C6 alkyl or fluoroalkyl; C1-C6 alkenyl; C1-C6 alkynyl; C1-C6 alkoxy or fluoroalkoxy; or C6-C10 aryl; C3-C10 heteroaryl or heterocyclic ring wherein anywhere from 1 to 4 ring atoms are independently O, S, N, or NR; C3-C10 cycloalkyl; or a (C1-C9 alkylene)-R 4 wherein up to four CH 2 units are independently replaced with O, CO, S, SO, SO 2 or NR;

or two R 3 groups taken together may form a=CH 2 or ═O group;

R 4 is H; azide; CF 3 ; CHF 2 ; OR; CCH; CO 2 R; OH; C6-C10 aryl, C3-C10 heteroaryl or heterocycloalkyl wherein anywhere from 1 to 4 ring atoms are independently O, S, N, or NR; C3-C10 cycloalkyl; NRR, NRCOR, CONRR, CN, halo, or SO 2 R;

R is independently H; OH; CO 2 H; CO 2 C1-C6 alkyl; C1-C6 alkyl; C1-C6 alkenyl;

C1-C6 alkynyl; C6-C10 aryl; C3-C10 heteroaryl or heterocycloalkyl wherein anywhere from 1 to 4 ring atoms are independently O, S, N, or NR; or C3-C10 cycloalkyl;

p is 0, 1, 2, or 3; and

q is 0, 1, 2, 3, 4, or 5.

13. A compound of formula Ib-v:

or a pharmaceutically acceptable salt thereof, wherein, independently for each occurrence:

Ring B is a C6-C10 aryl ring or C3-C10 heteroaryl or heterocyclic ring wherein anywhere from 1 to 4 ring atoms are independently O, S, N, or NR;

R 1 is halo; CN; F 5 S; SiR 3 ; OH; NRR; C1-C6 alkyl or fluoroalkyl; C1-C6 alkoxy or fluoroalkoxy; C1-C6 alkenyl; C1-C6 alkynyl; (C1-C9 alkylene)-R 4 wherein up to four CH 2 units are independently replaced with O, CO, S, SO, SO 2 or NR; C6-C10 aryl; C3-C10 heteroaryl or heterocyclic ring wherein anywhere from 1 to 4 ring atoms are independently O, S, N, or NR; or C3-C10 cycloalkyl;

R 2 is halo; OH; NRR; azide; CN; CO 2 R; C1-C6 alkyl or fluoroalkyl;C1-C6 alkoxy or fluoroalkoxy; C1-C6 alkenyl; C1-C6 alkynyl; C6-C10 aryl; C3-C13 heteroaryl or heterocyclic ring wherein anywhere from 1 to 4 ring atoms are independently O, S, N, or NR; C3-C10 cycloalkyl; or a (C1-C9 alkylene)-R 4 wherein up to four CH 2 units are independently replaced with O, CO, S, SO, SO 2 or NR;

or two R 2 groups taken together may form a=CH 2 or ═O group;

R 3 is halo; CN; CO 2 R; C1-C6 alkyl or fluoroalkyl; C1-C6 alkenyl; C1-C6 alkynyl;

C1-C6 alkoxy or fluoroalkoxy; or C6-C10 aryl; C3-C10 heteroaryl or heterocyclic ring wherein anywhere from 1 to 4 ring atoms are independently O, S, N, or NR; C3-C10 cycloalkyl; or a (C1-C9 alkylene)-R 4 wherein up to four CH 2 units are independently replaced with O, CO, S, SO, SO 2 or NR;

or two R 3 groups taken together may form a=CH 2 or ═O group;

R 4 is H; azide; CF 3 ; CHF 2 ; OR; CCH; CO 2 R; OH; C6-C10 aryl, C3-C10 heteroaryl or heterocycloalkyl wherein anywhere from 1 to 4 ring atoms are independently O, S, N, or NR; C3-C10 cycloalkyl; NRR, NRCOR, CONRR, CN, halo, or SO 2 R;

R is independently H; OH; CO 2 H; CO 2 C1-C6 alkyl; C1-C6 alkyl; C1-C6 alkenyl; C1-C6 alkynyl; C6-C10 aryl; C3-C10 heteroaryl or heterocycloalkyl wherein anywhere from 1 to 4 ring atoms are independently O, S, N, or NR; or C3-C10 cycloalkyl;

n is 0, 1, 2 or 3;

p is 0, 1, 2, or 3; and

q is 0, 1, 2, 3, 4, or 5.

14. A compound of formula Ib-vi:

or a pharmaceutically acceptable salt thereof, wherein, independently for each occurrence:

Ring B is a C6-C10 aryl ring or C3-C10 heteroaryl or heterocyclic ring wherein anywhere from 1 to 4 ring atoms are independently O, S, N, or NR;

R 1 is C6-C10 aryl or C3-C10 heteroaryl wherein anywhere from 1 to 4 ring atoms are independently O, S, N, or NR;

R 2 is halo; OH; NRR; azide; CN; CO 2 R; C1-C6 alkyl or fluoroalkyl; C1-C6 alkoxy or fluoroalkoxy; C1-C6 alkenyl; C1-C6 alkynyl; C6-C10 aryl; C3-C13 heteroaryl or heterocyclic ring wherein anywhere from 1 to 4 ring atoms are independently O, S, N, or NR; C3-C10 cycloalkyl; or a (C1-C9 alkylene)-R 4 wherein up to four CH 2 units are independently replaced with O, CO, S, SO, SO 2 or NR;

or two R 2 groups taken together may form a=CH 2 or ═O group;

R 3 is halo; CN; CO 2 R; C1-C6 alkyl or fluoroalkyl; C1-C6 alkenyl; C1-C6 alkynyl; C1-C6 alkoxy or fluoroalkoxy; or C6-C10 aryl; C3-C10 heteroaryl or heterocyclic ring wherein anywhere from 1 to 4 ring atoms are independently O, S, N, or NR; C3-C10 cycloalkyl; or a (C1-C9 alkylene)-R 4 wherein up to four CH 2 units are independently replaced with O, CO, S, SO, SO 2 or NR;

or two R 3 groups taken together may form a=CH 2 or ═O group;

R 4 is H; azide; CF 3 ; CHF 2 ; OR; CCH; CO 2 R; OH; C6-C10 aryl, C3-C10 heteroaryl or heterocycloalkyl wherein anywhere from 1 to 4 ring atoms are independently O, S, N, or NR; C3-C10 cycloalkyl; NRR, NRCOR, CONRR, CN, halo, or SO 2 R;

R is independently H; OH; CO 2 H; CO 2 C1-C6 alkyl; C1-C6 alkyl; C1-C6 alkenyl; C1-C6 alkynyl; C6-C10 aryl; C3-C10 heteroaryl or heterocycloalkyl wherein anywhere from 1 to 4 ring atoms are independently O, S, N, or NR; or C3-C10 cycloalkyl;

p is 0, 1, 2, or 3; and

q is 0, 1, 2, 3, 4, or 5.

15. A compound, or a pharmaceutically acceptable salt thereof, wherein the compound is selected from:

16. The compound of claim 15 , or a pharmaceutically acceptable salt thereof, wherein the compound is selected from:

17. A pharmaceutical composition comprising the compound or salt of claim 1 and a pharmaceutically acceptable carrier.

18. The pharmaceutical composition of claim 17 , further comprising one or more additional therapeutic agent(s).

19. The pharmaceutical composition of claim 18 , wherein the one or more additional therapeutic agent(s) comprises a CFTR modulator.

20. The pharmaceutical composition of claim 18 , wherein at least one additional therapeutic agent is

or pharmaceutically acceptable salt thereof.

21. The pharmaceutical composition of claim 18 , wherein at least one additional therapeutic agent is

or pharmaceutically acceptable salt thereof.

22. The pharmaceutical composition of claim 18 , wherein the additional therapeutic agents are

or

pharmaceutically acceptable salts thereof.

23. A method of treating cystic fibrosis in a patient comprising administering to the patient an effective amount of the compound or salt of claim 1 .

24. The method of claim 23 , further comprising administering to the patient one or more additional therapeutic agent(s) prior to, concurrent with, or subsequent to the compound or salt.

25. The method of claim 24 , wherein the one or more additional therapeutic agent(s) comprises a CFTR modulator.

26. The method of claim 24 , wherein at least one additional therapeutic agent is

or a pharmaceutically acceptable salt thereof.

27. The method of claim 24 , wherein at least one additional therapeutic agent is

or a pharmaceutically acceptable salt thereof.

28. A pharmaceutical composition comprising the compound or salt of claim 15 and a pharmaceutically acceptable carrier.

29. The pharmaceutical composition of claim 28 , further comprising one or more additional therapeutic agent(s).

30. The pharmaceutical composition of claim 29 , wherein the one or more additional therapeutic agent(s) comprises a CFTR modulator.

31. The pharmaceutical composition of claim 29 , wherein at least one additional therapeutic agent is

or pharmaceutically acceptable salt thereof.

32. The pharmaceutical composition of claim 29 , wherein at least one additional therapeutic agent is

or pharmaceutically acceptable salt thereof.

33. The pharmaceutical composition of claim 29 , wherein the additional therapeutic agents are

or

pharmaceutically acceptable salts thereof.

34. A method of treating cystic fibrosis in a patient comprising administering to the patient an effective amount of the compound or salt of claim 15 .

35. The method of claim 34 , further comprising administering to the patient one or more additional therapeutic agent(s) prior to, concurrent with, or subsequent to the compound or salt.

36. The method of claim 35 , wherein the one or more additional therapeutic agent(s) comprises a CFTR modulator.

37. The method of claim 35 , wherein at least one additional therapeutic agent is

or a pharmaceutically acceptable salt thereof.

38. The method of claim 35 , wherein at least one additional therapeutic agent is

or a pharmaceutically acceptable salt thereof.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 20, 2019
From: CONROY, ERICA; NICHOLLS, GEORGIA MCGAUGHEY
To: VERTEX PHARMACEUTICALS INCORPORATED
Reel/Frame 051339/0772 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 20, 2019
From: VERTEX PHARMACEUTICALS (SAN DIEGO) LLC
To: VERTEX PHARMACEUTICALS INCORPORATED
Reel/Frame 051339/0800 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 20, 2019
From: MILLER, MARK THOMAS; ANDERSON, COREY; ARUMUGAM, VIJAYALAKSMI; BEAR, BRIAN RICHARD; BINCH, HAYLEY MARIE; CLEMENS, JEREMY J.; CLEVELAND, THOMAS; COON, TIMOTHY RICHARD; FRIEMAN, BRYAN A.; GROOTENHUIS, PETER DIEDERIK JAN; GROSS, RAYMOND; HADIDA-RUAH, SARA SABINA; KHATUYA, HARIPADA; JOSHI, PRAMOD VIRUPAX; KRENITSKY, PAUL JOHN; LIN, CHUN-CHIEH; MARELIUS, GULIN ERDOGAN; MELILLO, VITO; MCCARTNEY, JASON; PIERRE, FABRICE JEAN DENIS; SILINA, ALINA; TERMIN, ANDREAS P.; UY, JOHNNY; ZHOU, JINGLAN
To: VERTEX PHARMACEUTICALS (SAN DIEGO) LLC
Reel/Frame 051381/0704 →
Continuity (6)
Continuation 15675000 · Aug 11, 2017
Division 14876525 · Oct 6, 2015
Provisional Application 62153120 · Apr 27, 2015
Provisional Application 62114767 · Feb 11, 2015
Provisional Application 62060182 · Oct 6, 2014
Related Publication 20190269683A1 · Sep 5, 2019
Cited By (10)
US 12,186,306 US 12,269,831 US 12,319,693 US 12,324,802 US 12,350,262 US 12,384,762 US 12,415,798 US 12,421,251 US 12,552,810 US 12,612,416