US2023265080A1PendingUtilityA1

Modulators of alpha-1 antitrypsin

68
Assignee: VERTEX PHARMAPriority: Oct 5, 2018Filed: Feb 9, 2023Published: Aug 24, 2023
Est. expiryOct 5, 2038(~12.2 yrs left)· nominal 20-yr term from priority
C07D 403/04C07D 519/00C07B 2200/05C07B 2200/13C07D 487/04C07D 487/14C07D 471/14A61P 11/00A61P 1/16A61K 31/4162A61K 31/5377A61K 31/496
68
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Claims

Abstract

Novel compounds, compositions, and methods of using and preparing the same, which may be useful for treating alpha-1 antitrypsin deficiency (AATD).

Claims

exact text as granted — not AI-modified
1 - 42 . (canceled) 
     
     
         43 . A method of preparing a compound of formula I-3 
       
         
           
           
               
               
           
         
         a salt thereof, or a deuterated derivative of any of the foregoing, comprising an internal alkyne amine coupling reaction in a compound of Formula I-4 
       
       
         
           
           
               
               
           
         
         or a salt thereof, 
         wherein, in the compounds of Formula I-3 and compounds of Formula I-4: 
         (i) R 0  is chosen from
 (a) C 1 -C 8  linear, branched, and cyclic alkyl groups, wherein the alkyl group is optionally substituted with 1-4 R A ; and 
 (b) 5- to 10-membered aromatic rings optionally substituted with 1-4 R A ,
 wherein each R A  is independently chosen from halogens, cyano, hydroxy, thiol, sulfonic acid, sulfonamide, sulfinamide, amino, amide, 5- to 10-membered aromatic rings, and C 1 -C 6  linear, branched, and cyclic groups, wherein the C 1 -C 6  linear, branched, and cyclic groups are chosen from alkyl, alkoxy, thioalkyl, alkylsulfoxide, alkylsulfonyl, alkylsulfonamide, alkylsulfinamide, aminoalkyl, and alkylamide, and wherein the 5- to 10-membered aromatic rings and C 1 -C 6  linear, branched, and cyclic groups are optionally substituted with 1-4 substituents independently chosen from halogens and methoxy; 
 
 
         (ii) R 1  is chosen from
 (a) C 1 -C 8  linear, branched, and cyclic alkyl groups, wherein the alkyl group is optionally substituted with 1-4 substituents independently chosen from
 halogens, 
 carboxylic acid, 
 cyano, and 
 C 1 -C 6  linear, branched, and cyclic groups, wherein the C 1 -C 6  linear, branched, and cyclic groups are chosen from alkyl and alkoxy groups, and wherein the C 1 -C 6  linear, branched, and cyclic groups are optionally substituted with 1-4 halogens, 
 
 (b) C 1 -C 8  linear, branched, and cyclic alkoxy groups optionally substituted with 1-4 substituents independently chosen from
 halogens, 
 cyano, and 
 C 1 -C 6  linear, branched, and cyclic alkyl groups that are optionally substituted with 1-4 halogens; 
 
 (c) C 1 -C 8  heterocycles, and 
 (d) C 2 -C 6  linear, branched, and cyclic alkenyl groups; 
 
         (iii) X 1  and X 2  are independently chosen from hydrogen, halogens, cyano, hydroxy, C 1 -C 6  linear, branched, and cyclic groups wherein the C 1 -C 6  linear, branched, and cyclic groups are chosen from alkyl, alkoxy, thioalkyl, and aminoalkyl groups, and wherein the C 1 -C 6  linear, branched, and cyclic groups are optionally substituted by 1-4 halogens; 
         (iv) each   represents a single or double bond, provided that no more than one   is a double bond; 
         (v) each R 3  is independently chosen from hydrogen, halogens, cyano, C 1 -C 6  linear, branched, and cyclic alkyl groups, and C 1 -C 6  linear, branched, and cyclic alkoxy groups, wherein the linear, branched, and cyclic alkyl and the linear, branched, and cyclic alkoxy groups are optionally substituted with 1-4 halogens; 
         (vi) n is an integer chosen from 0, 1, 2, and 3; and 
         (vii) Z 1 , Z 2 , and Z 3  are independently chosen from carbon, nitrogen, sulfur, and oxygen, wherein when Z 1 , Z 2 , and/or Z 3  are carbon or nitrogen, the valences of carbon and nitrogen are completed with hydrogen atoms, C 1 -C 8  linear, branched, and cyclic alkyls, or cyano. 
       
     
     
         44 - 48 . (canceled) 
     
     
         49 . A method of preparing a compound of formula S3 
       
         
           
           
               
               
           
         
         a salt thereof, or a deuterated derivative of any of the foregoing, comprising reacting a compound of formula C4 
       
       
         
           
           
               
               
           
         
         with at least one acid. 
       
     
     
         50 . The method of  claim 49 , wherein the compound of formula C4 is prepared by reacting a compound of formula C8 
       
         
           
           
               
               
           
         
         with 4-fluoroaniline in the presence of a palladium catalyst and at least one base. 
       
     
     
         51 . A method of preparing a compound of formula S6 
       
         
           
           
               
               
           
         
         a salt thereof, or a deuterated derivative of any of the foregoing, comprising heating a solution comprising a compound of formula C15 
       
       
         
           
           
               
               
           
         
         with at least one base. 
       
     
     
         52 . The method of  claim 51 , further comprising reacting a compound of formula C14 
       
         
           
           
               
               
           
         
         with 4-fluoroaniline, at least one base, and at least one palladium precatalyst to prepare the compound of formula S6. 
       
     
     
         53 . A compound of formula I-2: 
       
         
           
           
               
               
           
         
         a tautomer thereof, a pharmaceutically acceptable salt of the compound or the tautomer, or a deuterated derivative of the compound, the tautomer, or the pharmaceutically acceptable salt; 
         wherein: 
         (i) R 0  is chosen from
 (a) C 1 -C 8  linear, branched, and cyclic alkyl groups, wherein the alkyl group is optionally substituted with 1-4 R A ; and 
 (b) 5- to 10-membered aromatic rings optionally substituted with 1-4 R A ,
 wherein each R A  is independently chosen from halogens, cyano, hydroxy, thiol, sulfonic acid, sulfonamide, sulfinamide, amino, amide, 5- to 10-membered aromatic rings, and C 1 -C 6  linear, branched, and cyclic groups, wherein the C 1 -C 6  linear, branched, and cyclic groups are chosen from alkyl, alkoxy, thioalkyl, alkylsulfoxide, alkylsulfonyl, alkylsulfonamide, alkylsulfinamide, aminoalkyl, and alkylamide, and wherein the 5- to 10-membered aromatic rings and C 1 -C 6  linear, branched, and cyclic groups are optionally substituted with 1-4 substituents independently chosen from halogens and methoxy; 
 
 
         (ii) R 1  is chosen from
 (a) C 1 -C 8  linear, branched, and cyclic alkyl groups, wherein the alkyl group is optionally substituted with 1-4 substituents chosen from
 halogens, 
 carboxylic acid, 
 cyano, and 
 C 1 -C 6  linear, branched, and cyclic groups, wherein the C 1 -C 6  linear, branched, and 
 cyclic groups are chosen from alkyl and alkoxy groups, and wherein the C 1 -C 6  linear, branched, and cyclic groups are optionally substituted with 1-4 halogens, 
 
 (b) C 1 -C 8  linear, branched, and cyclic alkoxy groups optionally substituted with 1-4 substituents independently chosen from
 halogens, 
 cyano, and 
 C 1 -C 6  linear, branched, and cyclic alkyl groups that are optionally substituted with 1-4 halogens; 
 
 (c) C 1 -C 8  heterocycles, and 
 (d) C 2 -C 6  linear, branched, and cyclic alkenyl groups; 
 
         (iii) X 1  and X 2  are independently chosen from hydrogen, halogens, cyano, hydroxy, C 1 -C 6  linear, branched, and cyclic groups wherein the C 1 -C 6  linear, branched, and cyclic groups are chosen from alkyl, alkoxy, thioalkyl, and aminoalkyl groups, and wherein the C 1 -C 6  linear, branched, and cyclic groups are optionally substituted by 1-4 halogens; 
         (iv) each   represents a single or double bond, provided that no more than one   is a double bond; 
         (v) each R 3  is independently chosen from hydrogen, halogens, cyano, C 1 -C 6  linear, branched, and cyclic alkyl groups, and C 1 -C 6  linear, branched, and cyclic alkoxy groups, wherein the linear, branched, and cyclic alkyl and alkoxy groups are optionally substituted with 1-4 halogens; 
         (vi) n is an integer chosen from 0, 1, 2, and 3; 
         (vii) Z 1 , Z 2 , and Z 3  are independently chosen from carbon, nitrogen, sulfur, and oxygen, wherein when Z 1 , Z 2 , and/or Z 3  are carbon or nitrogen, the valences of carbon and nitrogen are completed with hydrogen atoms, C 1 -C 8  linear, branched, and cyclic alkyls, or cyano; and 
         (viii) PG is chosen from t-butyl carbamate (Boc), benzyl (Bn), tetrahydropyranyl (THP), 9-fluorenylmethyl carbamate (Fmoc) benzyl carbamate (Cbz), acetamide, trifluoroacetamide, triphenylmethylamine, benzylideneamine, and p-toluenesulfonamide with the proviso that at least one of Z 1 , Z 2 , or Z 3  is nitrogen. 
       
     
     
         54 . A compound of formula I-3: 
       
         
           
           
               
               
           
         
         a tautomer thereof, a pharmaceutically acceptable salt of the compound or the tautomer, or a deuterated derivative of the compound, the tautomer, or the pharmaceutically acceptable salt; 
         wherein: 
         (i) R 0  is chosen from
 (a) C 1 -C 8  linear, branched, and cyclic alkyl groups, wherein the alkyl group is optionally substituted with 1-4 R A ; and 
 (b) 5- to 10-membered aromatic rings optionally substituted with 1-4 R A  
 wherein each R A  is independently chosen from halogens, cyano, hydroxy, thiol, sulfonic acid, sulfonamide, sulfinamide, amino, amide, 5- to 10-membered aromatic rings, and C 1 -C 6  linear, branched, and cyclic groups, wherein the C 1 -C 6  linear, branched, and cyclic groups are chosen from alkyl, alkoxy, thioalkyl, alkylsulfoxide, alkylsulfonyl, alkylsulfonamide, alkylsulfinamide, aminoalkyl, and alkylamide, and wherein the 5- to 10-membered aromatic rings and C 1 -C 6  linear, branched, and cyclic groups are optionally substituted with 1-4 substituents chosen from halogens and methoxy; 
 
 
         (ii) R 1  is chosen from
 (a) C 1 -C 8  linear, branched, and cyclic alkyl groups, wherein the alkyl group is optionally substituted with 1-4 substituents independently chosen from
 halogens, 
 carboxylic acid, 
 cyano, and 
 C 1 -C 6  linear, branched, and cyclic groups, wherein the C 1 -C 6  linear, branched, and cyclic groups are chosen from alkyl and alkoxy groups, and wherein the C 1 -C 6  linear, branched, and cyclic groups are optionally substituted with 1-4 halogens, 
 
 (b) C 1 -C 8  linear, branched, and cyclic alkoxy groups optionally substituted with 1-4 substituents independently chosen from
 halogens, 
 cyano, and 
 C 1 -C 6  linear, branched, and cyclic alkyl groups that are optionally substituted with 1-4 halogens; 
 
 (c) C 1 -C 8  heterocycles, and 
 (d) C 2 -C 6  linear, branched, and cyclic alkenyl groups; 
 
         (iii) X 1  and X 2  are independently chosen from hydrogen, halogens, cyano, hydroxy, C 1 -C 6  linear, branched, and cyclic groups wherein the C 1 -C 6  linear, branched, and cyclic groups are chosen from alkyl, alkoxy, thioalkyl, and aminoalkyl groups, and wherein the C 1 -C 6  linear, branched, and cyclic groups are optionally substituted by 1-4 halogens; 
         (iv) each   represents a single or double bond, provided that no more than one   is a double bond; 
         (v) each R 3  is independently chosen from hydrogen, halogens, cyano, C 1 -C 6  linear, branched, and cyclic alkyl groups, and C 1 -C 6  linear, branched, and cyclic alkoxy groups, wherein the linear, branched, and cyclic alkyl and alkoxy groups are optionally substituted with 1-4 halogens; 
         (vi) n is an integer chosen from 0, 1, 2, and 3; and 
         (vii) Z 1 , Z 2 , and Z 3  are independently chosen from carbon, nitrogen, sulfur, and oxygen, wherein when Z 1 , Z 2 , and/or Z 3  are carbon or nitrogen, the valences of carbon and nitrogen are completed with hydrogen atoms, C 1 -C 8  linear, branched, and cyclic alkyls, or cyano. 
       
     
     
         55 . A compound of formula I-4: 
       
         
           
           
               
               
           
         
         a tautomer thereof, a pharmaceutically acceptable salt of the compound or the tautomer, or a deuterated derivative of the compound, the tautomer, or the pharmaceutically acceptable salt; 
         wherein: 
         (i) R 0  is chosen from
 (a) C 1 -C 8  linear, branched, and cyclic alkyl groups, wherein the alkyl group is optionally substituted with 1-4 R A ; and 
 (b) 5- to 10-membered aromatic rings optionally substituted with 1-4 R A ,
 wherein each R A  is independently chosen from halogens, cyano, hydroxy, thiol, sulfonic acid, sulfonamide, sulfinamide, amino, amide, 5- to 10-membered aromatic rings, and C 1 -C 6  linear, branched, and cyclic groups, wherein the C 1 -C 6  linear, branched, and cyclic groups are chosen from alkyl, alkoxy, thioalkyl, alkylsulfoxide, alkylsulfonyl, alkylsulfonamide, alkylsulfinamide, aminoalkyl, and alkylamide, and wherein the 5- to 10-membered aromatic rings and C 1 -C 6  linear, branched, and cyclic groups are optionally substituted with 1-4 substituents independently chosen from halogens and methoxy; 
 
 
         (ii) R 1  is chosen from
 (a) C 1 -C 8  linear, branched, and cyclic alkyl groups, wherein the alkyl group is optionally substituted with 1-4 substituents independently chosen from
 halogens, 
 carboxylic acid, 
 cyano, and 
 C 1 -C 6  linear, branched, and cyclic groups, wherein the C 1 -C 6  linear, branched, and cyclic groups are chosen from alkyl and alkoxy groups, and wherein the C 1 -C 6  linear, branched, and cyclic groups are optionally substituted with 1-4 halogens, 
 
 (b) C 1 -C 8  linear, branched, and cyclic alkoxy groups optionally substituted with 1-4 substituents independently chosen from
 halogens, 
 cyano, and 
 C 1 -C 6  linear, branched, and cyclic alkyl groups that are optionally substituted with 1-4 halogens; 
 
 (c) C 1 -C 8  heterocycles, and 
 (d) C 2 -C 6  linear, branched, and cyclic alkenyl groups; 
 
         (iii) X 1  and X 2  are independently chosen from hydrogen, halogens, cyano, hydroxy, C 1 -C 6  linear, branched, and cyclic groups wherein the C 1 -C 6  linear, branched, and cyclic groups are chosen from alkyl, alkoxy, thioalkyl, and aminoalkyl groups, and wherein the C 1 -C 6  linear, branched, and cyclic groups are optionally substituted by 1-4 halogens; 
         (iv) each   represents a single or double bond, provided that no more than one   is a double bond; 
         (v) each R 3  is independently chosen from hydrogen, halogens, cyano, C 1 -C 6  linear, branched, and cyclic alkyl groups, and C 1 -C 6  linear, branched, and cyclic alkoxy groups, wherein the linear, branched, and cyclic alkyl and alkoxy groups are optionally substituted with 1-4 halogens; 
         (vi) n is an integer chosen from 0, 1, 2, and 3; and 
         (vii) Z 1 , Z 2 , and Z 3  are independently chosen from carbon, nitrogen, sulfur, and oxygen, wherein when Z 1 , Z 2 , and/or Z 3  are carbon or nitrogen, the valences of carbon and nitrogen are completed with hydrogen atoms, C 1 -C 8  linear, branched, and cyclic alkyls, or cyano. 
       
     
     
         56 . A compound of formula I-5: 
       
         
           
           
               
               
           
         
         a tautomer thereof, a pharmaceutically acceptable salt of the compound or the tautomer, or a deuterated derivative of the compound, the tautomer, or the pharmaceutically acceptable salt; 
         wherein: 
         (i) R 1  is chosen from
 (a) C 1 -C 8  linear, branched, and cyclic alkyl groups, wherein the alkyl group is optionally substituted with 1-4 substituents independently chosen from
 halogens, 
 carboxylic acid, 
 cyano, and 
 C 1 -C 6  linear, branched, and cyclic groups, wherein the C 1 -C 6  linear, branched, and cyclic groups are chosen from alkyl and alkoxy groups, and wherein the C 1 -C 6  linear, branched, and cyclic groups are optionally substituted with 1-4 halogens, 
 
 (b) C 1 -C 8  linear, branched, and cyclic alkoxy groups optionally substituted with 1-4 substituents independently chosen from
 halogens, 
 cyano, and 
 C 1 -C 6  linear, branched, and cyclic alkyl groups that are optionally substituted with 1-4 halogens; 
 
 (c) C 1 -C 8  heterocycles, and 
 (d) C 2 -C 6  linear, branched, and cyclic alkenyl groups; 
 
         (ii) X 1  and X 2  are independently chosen from hydrogen, halogens, cyano, hydroxy, C 1 -C 6  linear, branched, and cyclic groups wherein the C 1 -C 6  linear, branched, and cyclic groups are chosen from alkyl, alkoxy, thioalkyl, and aminoalkyl groups, and wherein the C 1 -C 6  linear, branched, and cyclic groups are optionally substituted by 1-4 halogens; 
         (iii) each   represents a single or double bond, provided that no more than one   is a double bond; 
         (iv) each R 3  is independently chosen from hydrogen, halogens, cyano, C 1 -C 6  linear, branched, and cyclic alkyl groups, and C 1 -C 6  linear, branched, and cyclic alkoxy groups, wherein the linear, branched, and cyclic alkyl and alkoxy groups are optionally substituted with 1-4 halogens; 
         (v) n is an integer chosen from 0, 1, 2, and 3; 
         (vi) Z 1 , Z 2 , and Z 3  are independently chosen from carbon, nitrogen, sulfur, and oxygen, wherein when Z 1 , Z 2 , and/or Z 3  are carbon or nitrogen, the valences of carbon and nitrogen are completed with hydrogen atoms, C 1 -C 8  linear, branched, and cyclic alkyls, or cyano; and 
         (vii) Y 1  is chosen from halogens. 
       
     
     
         57 . A compound of formula I-7: 
       
         
           
           
               
               
           
         
         a tautomer thereof, a pharmaceutically acceptable salt of the compound or the tautomer, or a deuterated derivative of the compound, the tautomer, or the pharmaceutically acceptable salt; 
         wherein: 
         (i) R 1  is chosen from
 (a) C 1 -C 8  linear, branched, and cyclic alkyl groups, wherein the alkyl group is optionally substituted with 1-4 substituents independently chosen from
 halogens, 
 carboxylic acid, 
 cyano, and 
 C 1 -C 6  linear, branched, and cyclic groups, wherein the C 1 -C 6  linear, branched, and cyclic groups are chosen from alkyl and alkoxy groups, and wherein the C 1 -C 6  linear, branched, and cyclic groups are optionally substituted with 1-4 halogens, 
 
 (b) C 1 -C 8  linear, branched, and cyclic alkoxy groups optionally substituted with 1-4 substituents independently chosen from
 halogens, 
 cyano, and 
 C 1 -C 6  linear, branched, and cyclic alkyl groups that are optionally substituted with 1-4 halogens; 
 
 (c) C 1 -C 8  heterocycles, and 
 (d) C 2 -C 6  linear, branched, and cyclic alkenyl groups; 
 
         (ii) X 1  and X 2  are independently chosen from hydrogen, halogens, cyano, hydroxy, C 1 -C 6  linear, branched, and cyclic groups wherein the C 1 -C 6  linear, branched, and cyclic groups are chosen from alkyl, alkoxy, thioalkyl, and aminoalkyl groups, and wherein the C 1 -C 6  linear, branched, and cyclic groups are optionally substituted by 1-4 halogens; 
         (iii) each   represents a single or double bond, provided that no more than one   is a double bond; 
         (iv) each R 3  is independently chosen from hydrogen, halogens, cyano, C 1 -C 6  linear, branched, and cyclic alkyl groups, and C 1 -C 6  linear, branched, and cyclic alkoxy groups, wherein the linear, branched, and cyclic alkyl and alkoxy groups are optionally substituted with 1-4 halogens; 
         (v) n is an integer chosen from 0, 1, 2, and 3; 
         (vi) Z 1 , Z 2 , and Z 3  are independently chosen from carbon, nitrogen, sulfur, and oxygen, wherein when Z 1 , Z 2 , and/or Z 3  are carbon or nitrogen, the valences of carbon and nitrogen are completed with hydrogen atoms, C 1 -C 8  linear, branched, and cyclic alkyls, or cyano; and 
         (vii) Y 1  and Y 2  are independently chosen from halogens. 
       
     
     
         58 . A compound chosen from: 
       
         
           
           
               
               
           
         
         
           
           
               
               
           
         
         and tautomers thereof, deuterated derivatives of those compounds and tautomers, and salts of any of the foregoing. 
       
     
     
         59 . The compound of  claim 58 , wherein the compound is chosen from: 
       
         
           
           
               
               
           
         
         and tautomers thereof, deuterated derivatives of those compounds and tautomers, and salts of any of the foregoing. 
       
     
     
         60 . The compound of  claim 58 , wherein the compound is chosen from: 
       
         
           
           
               
               
           
         
         and tautomers thereof, deuterated derivatives of those compounds and tautomers, and salts of any of the foregoing.

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