IP Library Granted Patent US 6,878,691
Granted Patent B2
US 6,878,691 · App. 10/429,485 · Granted Apr 12, 2005

6-11 bicyclic ketolide derivatives

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Quick Facts
Patent No.
US 6,878,691
App. No.
10/429,485
Granted
Apr 12, 2005
Kind
B2
Abstract

The present invention discloses compounds of formula I, or pharmaceutically acceptable salts, esters, or prodrugs thereof: which exhibit antibacterial properties. The present invention further relates to pharmaceutical compositions comprising the aforementioned compounds for administration to a subject in need of antibiotic treatment. The invention also relates to methods of treating a bacterial infection in a subject by administering a pharmaceutical composition comprising the compounds of the present invention. The invention further includes process by which to make the compounds of the present invention.

Claims (838)

1. A compound represented by the formula:

or its pharmaceutically acceptable salt, or ester,

wherein

R p is a hydroxy protecting group;

R 1 is independently selected from:

(1) aryl;

(2) substituted aryl;

(3) heteroaryl; or

(4) substituted heteroaryl;

R 2 is independently selected from:

(1) hydrogen;

(2) halogen;

(3) C 1 -C 12 alkyl optionally containing 0, 1, 2, or 3 heteroatoms selected from O, S or N, optionally substituted with one or more substituents selected from halogen, aryl, substituted aryl, heteroaryl, or substituted heteroaryl;

(4) C 2 -C 12 alkenyl optionally containing 0, 1, 2, or 3 heteroatoms selected from O, S and N, optionally substituted with one or more substituents selected from halogen, aryl, substituted aryl, heteroaryl, or substituted heteroaryl; or

(5) C 2 -C 12 Alkynyl optionally containing 0, 1, 2, or 3 heteroatoms selected from O, S and N, optionally substituted with one or more substituents selected from halogen, aryl, substituted aryl, heteroaryl, or substituted heteroaryl;

n=0, 1 or 2;

R 11 is independently hydrogen, R 1 or R 2 , where R 1 and R 2 are as previously defined;

A and B taken together with the carbon atom to which they are attached are selected from:

a) C═O;

b) C═N—O—R 11 , where R 11 is as previously defined;

c) C═N—O—Ar 1 —M—Ar 2 , wherein

(1) —Ar 1 — is R 31 , where R 31 is independently selected from:

(a) R 1 , where R 1 is as previously defined;

(b) C 1 -C 12 alkyl optionally containing 0, 1, 2, or 3 heteroatoms selected from O, S or N, optionally substituted with one or more substituents selected from halogen, aryl, substituted aryl, heteroaryl, or substituted heteroaryl;

(c) C 2 -C 12 alkenyl optionally containing 0, 1, 2, or 3 heteroatoms selected from O, S and N, optionally substituted with one or more substituents selected from halogen, aryl, substituted aryl, heteroaryl, or substituted heteroaryl; or

(d) C 2 -C 12 alkynyl optionally containing 0, 1, 2, or 3 heteroatoms selected from O, S and N, optionally substituted with one or more substituents selected from halogen, aryl, substituted aryl, heteroaryl, or substituted heteroaryl;

(2) —M— is absent or selected from:

(a) —C 1 -C 12 alkyl optionally containing:

0-3 heteroatoms selected from O, S or N; and

0-3 groups selected from —CN—, —N═N—, —C(O)—

(b) —C 2 -C 12 alkenyl optionally containing:

0-3 heteroatoms selected from O, S or N; and

0-3 groups selected from —C═N—, —N═N—, —C(O)—;

(c) —C 2 -C 1 -2 alkynyl optionally containing;

0-3 heteroatoms selected from O, S or N; and

0-3 groups selected from —C═N—, —N═N—, —C(O)—;

(d) substituted aryl;

(e) substituted heteroaryl; or

(f) substituted heterocyclo alkyl; and

(3) —Ar 2 is selected from:

(a) aryl;

(b) substituted aryl;

(c) heteroaryl; or

(d) substituted heteroaryl;

one of X and Y is hydrogen and the other is selected from:

a) hydrogen;

b) deuterium;

c) —OH;

d) —OR p , where R p is as previously defined;

e) —NR 4 R 5 , where R 4 and R 5 are each independently selected from:

(1) hydrogen;

(2) C 1 -C 12 alkyl, optionally substituted with one or more substituents selected from halogen, aryl, substituted aryl, heteroaryl and substituted heteroaryl; or

(3) R 4 and R 5 , taken together with the nitrogen atom to which they are attached form a 3-10 membered heteroalkyl ring containing 0-2 additional hetero atoms selected from O, S and N; or

alternatively, X and Y Taken Together with the Carbon Atom to which they are Attached are selected from:

a) C═O;

b) C═N—Q, wherein Q is selected from:

(1) —R 11 , where R 11 is as previously defined;

(2) amino protecting group;

(3) —C(O)R 11 , where R 11 , is as previously defined;

(4) —OR 6 , where R 6 is independently selected from:

(a) hydrogen;

(b) —CH 2 O(CH 2 ) 2 OCH 3 ,

(c) —CH 2 O(CH 2 O) n CH 3 , where n is as previously defined;

(d) —C 1 -C 12 alkyl, optionally substituted with one or more substituents selected from aryl, substituted aryl, heteroaryl or substituted heteroaryl;

(e) —C 3 -C 12 cycloalkyl;

(f) —C(O)—C 1 -C 12 alkyl;

(g) —C(O)—C 3 -C 12 cycloalkyl;

(h) —C(O)—R 1 , where R 1 is as previously defined; or

(i) —Si(R a )(R b )(R c ), wherein R a , R b and R c are each independently selected from C 1 -C 1 -2 alkyl, aryl or substituted aryl; or

(5) O—C(R 7 )(R 8 )—O—R 6 , where R 6 is as previously defined, provided that R 6 is not C(O)—C 1 -C 12 alkyl, C(O)—C 3 -C 12 cycloalkyl, or C(O)R 1 , and R 7 and R 8 taken together with the carbon atom to which they are attached form a C 3 -C 12 cycloalkyl group or each independently is selected from:

(a) hydrogen; or

(b) C 1 -C 12 alkyl;

L is selected from:

a) —CH(OH)CH 3 ;

b) C 1 -C 6 alkyl, optionally substituted with one or more substituents selected from aryl, substituted aryl, heteroaryl, or substituted heteroaryl;

c) C 2 -C 6 alkenyl, optionally substituted with one or more substituents selected from aryl, substituted aryl, heteroaryl, or substituted heteroaryl; or

d) C 2 -C 6 alkynyl, optionally substituted with one or more substituents selected from aryl, substituted aryl, heteroaryl, or substituted heteroaryl; or

W is —NR 20 R 21 , where R 20 and R 21 are each independently selected from:

a) hydrogen;

b) C 1 -C 12 alkyl, optionally substituted with one or more substituents selected from halogens aryl, substituted aryl, heteroaryl or substituted heteroaryl;

c) C 2 -C 12 alkenyl, optionally substituted with one or more substituents selected from halogen, aryl, substituted aryl, heteroaryl or substituted heteroaryl;

d) C 2 -C 12 alkynyl, optionally substituted with one or more substituents selected from halogen, aryl, substituted aryl, heteroaryl or substituted heteroaryl; or

e) R 20 and R 21 , taken together with the nitrogen atom to which they are attached form a heterocycloalkyl moiety, or

Z is selected from:

a) hydrogen;

b) methyl; or

c) halogen; and

R 2 ′ is hydrogen or R p , where R p is as previously defined.

2. A compound according to claim 1 which is represented by the formula:

wherein A, B, R 2 ′, Q, W, and Z are as defined in claim 1 .

3. A compound according to claim 1 which is represented by the formula:

wherein A, B, R 2 ′, Q, and Z are as defined in claim 1 .

4. A compound according to claim 1 which is represented by the formula:

wherein Ar 1 , Ar 2 , R 2 ′, M, Q, W, and Z are as defined in claim 1 .

5. A compound according to claim 1 which is represented by the formula:

wherein Ar 1 , Ar 2 , R 2 ′, M, Q and Z are as defined in claim 1 and Ac is acetyl.

6. A compound according to claim 1 which is represented by the formula:

wherein Ar 1 , Ar 2 , R 2 ′, M, and Z are as defined in claim 1 .

7. A compound according to claim 1 which is represented by the formula:

wherein Ar 1 , Ar 2 , R 2 ′, M, and Q are as defined in claim 1 .

8. A compound according to claim 1 which is selected from:

(1) Compound of formula I: A and B taken together with the carbon atom to which they are attached are C═O, X and Y taken together with the carbon atom to which they attached are C═N—Ac, L-CH 2 CH 3 , Z═H and R 2 ′═H;

(2) Compound of formula I: A and B taken together with the carbon atom to which they are attached are C═N—O—CH 2 —Ph, X and Y taken together with the carbon atom to which they are attached are C═N—Ac, L═CH 2 CH 3 , Z═H and R 2 ′═H;

(3) Compound of formula I: A and B taken together with the carbon atom to which they are attached are C═N—O—CH 2 -(3-pyridyl), X and Y taken together with the carbon atom to which they are attached are C═N—Ac, L═CH 2 CH 3 , Z═H and R 2 ′═H;

(4) Compound of formula I: A and B taken together with the carbon atom to which they are attached are C═N—O—CH 2 -(2-pyridyl), X and Y taken together with the carbon atom to which they are attached are C═N—Ac, L═CH 2 CH 3 , Z═H and R 2 ′═H;

(5) Compound of formula I: A and B taken together with the carbon atom to which they are attached are C═N—O—CH 2 -(3-quinolyl), X and Y taken together with the carbon atolls to which they are attached are CN—Ac, L═CH 2 CH 3 , Z═H and R 2 ′═H;

(6) Compound of formula I: A and B taken together with the carbon atom to which they are attached are C═N—O—CH 2 -(2-quinolyl), X and Y taken together with the carbon atom to which they are attached are C═N—Ac, L═CH 2 CH 3 , Z═H and R 2 ′═H;

(7) Compound of formula I: A and B taken together with the carbon atom to which they are attached are C═N—O—(5-pyridin-2-ylthiophen-2yl)-methyl, X and Y taken together with the carbon atom to which they are attached are C═N—Ac, L═CH 2 CH 3 , Z═H and R 2 ′═H;

(8) Compound of formula I: A and B taken together with the carbon atom to which they are attached are CN—O—(3-pyrimidin-2-ylprop-2-ynyl), X and Y taken together with the carbon atom to which they are attached are C—N—Ac, L═CH 2 CH 3 , Z═H and R 2 ′═H;

(9) Compound of formula I: A and B taken together with the carbon atom to which they are attached are C═N—O—Ph, X and Y taken together with the carbon atom to which they are attached are C—N—Ac, L═CH 2 CH 3 , Z═H and R 2 ′═H;

(10) Compound of formula I: A and B taken together with the carbon atom to which they are attached are C═O, X and Y taken together with the carbon atom to which they are attached are C═N—O—CH 2 —O—CH 3 , L═CH 2 CH 3 , Z═H and R 2 ′═H;

(11) Compound of formula I: A and B taken together with the carbon atom to which they are attached are C═NOCH 2 —Ph, X and Y taken together with the carbon atom to which they are attached are C═N—O—CH 2 —O—CH 3 , L═CH 2 CH 3 , Z═H and R 2 ′═H;

(12) Compound of formula I: A and B taken together with the carbon atom to which they are attached are COO, X and Y taken together with the carbon atom to which they are attached are C═O, L═CH 2 CH 3 , Z═H and R 2 ′═Ac;

(13) Compound of formula I: A and B taken together with the carbon atom to which they are attached are C═O, X and Y taken together with the carbon atom to which they are attached are C═O, L═CH 2 CH 3 , Z═H, and R 2 ′═H;

(14) Compound of formula I: A and B taken together with the carbon atom to which they are attached are C═N—O—CH 2 —Pb, X and Y taken together with the carbon atom to which they are attached are C═O, L═CH 2 CH 3 , Z═H, and R 2 ′═H

(15) Compound of formula I: A and B taken together with the carbon atom to which they are attached are C═N—O—(CH 2 ) 2 —Ph, X and Y taken together with the carbon atom to which they are attached are C═N—Ac, L═CH 2 CH 3 , Z═H, and R 2 ′═H;

(16) Compound of formula I: A and B taken together with the carbon atom to which they are attached are C═N—O(CH 2 ) 3 —Ph, X and Y taken together with the carbon atom to which they are attached are C═N—Ac, L═CH 2 CH 3 , Z═H, and R 2 ′═H; or

(17) Compound of formula I: A and B taken together with the carbon atom to which they are attached are C═N—CH 2 —CH═CH—Ph, X and Y taken together with the carbon atom to which they are attached are C═N—Ac, L═CH 2 CH 3 , Z═H, and R 2 ′═H.

9. A pharmaceutical composition comprising a therapeutically effective amount of a compound of claim 1 or a pharmaceutically-acceptable salt, or ester thereof, in combination with a pharmaceutically acceptable carrier.

10. A method for treating a bacterial infection in a subject in need of such treatment, comprising administering to said subject a therapeutically-effective amount of a pharmaceutical composition according to claim 9 .

11. A process for preparing a compound represented by the formula

where V is selected from: N—Q or O; Hx is halogen or methyl; and A, B, Q, and R 2 ′ are as defined in claim 1 , comprising the step of

(a) reacting a compound represented by the formula

 where A, B, V, and R 2 are as previously defined in claim 1 , with a halogenating agent or methylating agent in the presence of a base.

12. A process for the preparation of a compound represented by the formula

where V is selected from N—Q or O; and Q, Ar 1 , M, Ar 2 and R 2 ′ are as defined in claim 1 , comprising the steps of:

(a) reacting a compound represented by the formula (Ia)

 where V and R 2 ′ are as previously defined in claim 1 , with a reagent or reagents capable of performing oxidative cleavage

 to provide a compound represented by the formula (Ib)

 where V and R 2 ′ are as previously defined in claim 1 ;

(b) reacting a compound of formula (Ib) from step (a) with an oxidizing agent to provide a compound represented by the formula (Ic)

 where V and R 2 ′ as previously defined in claim 1 ; and

(c) reacting a compound of formula (Ic) from step (b) with a compound of the formula Ar 2 —M—Ar 1 —O—NH 2 , wherein Ar 1 , Ar 2 , and M are defined as in claim 1 , in the presence of an acid or a base; and

(d) optionally deprotecting the compound from step (c).

13. A process for the preparation of a compound represented by the formula:

where V is selected from N—Q or O; and Q, Ar 1 , M, Ar 2 and R 2 ′ ale as defined in claim 1 , comprising the steps of:

(a) reacting a compound represented by the formula (Ib)

 where V and R 2 ′ are as previously defined in claim 1 , with a compound of the formula Ar 2 —M—Ar 1 —O—N 2 , wherein Ar 1 , Ar 2 , and M are defined as in claim 1 , in the presence of an acid or a base;

(b) reacting a compound from step (a) with an oxidizing; and

(c) optionally deprotecting the compound formed in step (b).

14. A process for the preparation of a compound represented by the formula

where V is selected from N—Q or O; and Q, Ar 1 , M, Ar 2 , R 2 ′, and Z are as defined in claim 1 , comprising the steps of:

(a) reacting a compound represented by the formula (Ia)

 where V and R 2 ′ are as previously defined in claim 1 , with an oxidizing agent to provide a 3-keto compound represented by the formula (Ib)

 where V and R 2 are as previously defined in claim 1 ;

(b) reacting a compound of formula (Ib) with a halogenating agent or a methylating agent in the presence of a base to provide a compound represented by the formula (Ic)

 where V, Z and R z are as previously defined in claim 1 ;

(c) reacting a compound of formula (Ic) with a reagent or regents capable of performing oxidative cleavage to provide a compound represented by the formula (Id)

 where V, Z and R 2 are as previously defined in claim 1 ;

(d) reacting a compound of formula (Id) ith a compound of the formula Ar 2 —M—Ar 1 —O—NH 2 , wherein Ar 1 , Ar 2 , and M are defined as in claim 1 , in the presence of an acid or a base; and

(e) optionally deprotecting of a compound from step (d).

15. A process of any of claims 12 , 13 , or 14 , further comprising the step of deprotecting.

16. A compound according to claim 1 , wherein A and B taken together with the carbon to which they are attached are C═O and X and Y taken together with the carbon atom to which they are attached are C═N—Q.

17. A compound according to claim 1 , wherein A and B taken together with the carbon to which they are attached are C—O, X and Y taken together with the carbon atom to which they are attached are C═N—Q, and W is N(CH 3 ) 2 .

18. A compound according to claim 1 , wherein A and B taken together with the carbon to which they are attached are C═O, X and Y taken together with the carbon atom to which they are attached are C═N—Ac, and W is N(CH 3 ).

19. A compound of formula VI of claim 5 , wherein Ar 1 is —CH 2 —(heteroaryl) or —CH 2 -substituted heteroaryl).

20. A compound of claim 19 , wherein the heteroaryl is independently selected from:

a. pyridinyl;

b. pyrazinyl;

c. pyridinyl;

d. pyrrolyl;

e. pyrazolyl

f. imidazolyl;

g. thiazolyl;

h. oxazolyl;

i. isoxazolyl;

j. thiadiazolyl;

k. oxadiazolyl;

l. thiophenyl;

m. furanyl;

n. quinolinyl;

o. isoquinolinyl;

p. benzimidazolyl;

q. benzoxazolyl; or

r. quinoxalinyl.

21. A compound according to claim 19 or 20 ; wherein M is absent.

22. A compound according to claim 19 or 20 , wherein M is absent and Ar 2 is heteroaryl or substituted heteroaryl.

23. A compound according to claim 22 , wherein heteroaryl is selected from:

a. pyridinyl;

b. pyrazinyl;

c. pyrimidinyl;

d. pyrrolyl;

e. pyrazolyl

f. imidazolyl;

g. thiazolyl;

h. oxazolyl;

i. isoxazolyl;

j. thiadiazolyl;

k. oxadiazolyl;

l. thiophenyl;

m. furanyl;

n. quinolinyl;

o. isoquinolinyl;

p. benzimidazolyl;

q. benzoxazolyl; or

r. quinoxalinyl.

24. A compound of formula I of claim 1 , wherein A and B taken together with the carbon atom to which they are attached are C═N—O—R 11 , X and Y taken together with the carbon atom to which they are attached are C—N—Q, L is ethyl, and W is N(CH 3 ).

25. A compound of claim 24 , selected from compounds delineated in the following table:

Number

Q

—R 11

Z

R 2 ′

(1)

Ac

H

H

(2)

Ac

H

H

(3)

Ac

H

H

(4)

Ac

H

H

(5)

Ac

H

H

(6)

Ac

H

H

(7)

Ac

H

H

(8)

MOM

H

H

(9)

Ac

H

H

(10)

Ac

H

H

(11)

Ac

H

H

(12)

Ac

H

H

(13)

Ac

H

H

(14)

Ac

H

H

(15)

Ac

H

H

(16)

Ac

H

H

(17)

Ac

H

H

(18)

Ac

H

H

(19)

Ac

H

H

(20)

Ac

H

H

(21)

Ac

H

H

(22)

Ac

H

H

(23)

Ac

H

H

(24)

Ac

H

H

(25)

Ac

H

H

(26)

Ac

H

H

(27)

Ac

H

H

(28)

Ac

H

H

(29)

Ac

H

H

(30)

Ac

H

H

(31)

Ac

F

H

(32)

Ac

F

H

(33)

Ac

H

H

(34)

Ac

F

H

(35)

Ac

H

H

(36)

Ac

H

H

(37)

Ac

H

H

(38)

Ac

H

H

(39)

Ac

H

H

(40)

Ac

H

H

(41)

Ac

H

H

(42)

Ac

H

H

(43)

Ac

H

H

(44)

Ac

H

H

(45)

Ac

H

H

(46)

Ac

H

H

(47)

Ac

H

H

(48)

Ac

H

H

(49)

Ac

H

H

(50)

Ac

H

H

(51)

Ac

H

H

(52)

Ac

H

H

(53)

Ac

H

H

(54)

Ac

H

H

(55)

Ac

H

H

(56)

H

H

H

(57)

Ac

H

H

(58)

Ac

H

H

(59)

Ac

F

H

(60)

Ac

H

H

(61)

Ac

H

H

(62)

Ac

H

H

(63)

Ac

H

H

(64)

Ac

H

H

(65)

Ac

H

H

(66)

Ac

H

H

(67)

Ac

H

H

(68)

H

H

H

(69)

Ac

H

H

(70)

Ac

H

H

26. A compound of formula VI of claim 5 , selected from compounds delineated in the following table:

Number

Q

—Ar 1 —M—Ar 2

Z

R 2 ′

(1)

Ac

H

H

(2)

Ac

H

H

(3)

Ac

H

H

(4)

Ac

H

H

(5)

Ac

H

H

(6)

Ac

H

H

(7)

Ac

H

H

(8)

Ac

H

H

(9)

Ac

H

H

(10)

Ac

H

H

(11)

Ac

H

H

(12)

Ac

H

H

(13)

Ac

H

H

(14)

Ac

H

H

(15)

Ac

F

H

(16)

Ac

F

H

(17)

Ac

H

H

(18)

Ac

H

H

(19)

Ac

H

H

(20)

Ac

H

H

(21)

Ac

H

H

(22)

Ac

H

H

(23)

Ac

H

H

(24)

Ac

H

H

(25)

Ac

H

H

(26)

Ac

F

H

(27)

Ac

H

H

(28)

Ac

H

H

(29)

Ac

H

H

(30)

Ac

H

H

(31)

Ac

H

H

(32)

Ac

F

H

(33)

Ac

H

H

(34)

Ac

H

H

(35)

Ac

H

H

(36)

Ac

F

H

(37)

Ac

H

H

(38)

H

H

H

(39)

Ac

H

H

(40)

Ac

H

H

(41)

H

H

H

(42)

Ac

H

H

(43)

H

H

H

(44)

H

H

H

(45)

H

H

H

(46)

Ac

H

H

(47)

Ac

H

H

(48)

Ac

H

H

(49)

H

H

H

(50)

H

H

H

(51)

Ac

H

H

(52)

H

H

H

(53)

Ac

H

H

(54)

Ac

H

H

(55)

Ac

F

H

(56)

H

F

H

(57)

H

H

H

(58)

Ac

H

H

(59)

Ac

H

H

(60)

Ac

H

H

(61)

Ac

F

H

(62)

Ac

H

H

(63)

Ac

H

H

(64)

Ac

H

H

(65)

Ac

H

H

(66)

Ac

H

H

(67)

Ac

H

H

(68)

Ac

H

H

(69)

Ac

H

H

(70)

Ac

H

H

(71)

Ac

H

H

(72)

Ac

H

H

(73)

Ac

H

H

(74)

Ac

H

H

(75)

Ac

H

H

(76)

Ac

H

H

(77)

Ac

H

H

(78)

Ac

H

H

(79)

Ac

H

H

(80)

Ac

H

H

(81)

Ac

H

H

(82)

Ac

H

H

(83)

Ac

H

H

(84)

Ac

H

H

(85)

Ac

H

H

(86)

Ac

H

H

(87)

Ac

H

H

.

Assignments (1)
SECURITY AGREEMENT Recorded Jan 20, 2004
From: SILICON VALLEY BANK DBA SILICON VALLEY EAST
To: ENANTA PHARMACEUTICALS, INC.
Reel/Frame 014269/0426 →