US2016251380A1PendingUtilityA1

Tricyclic benzoxaborole compounds and uses thereof

Assignee: GLAXOSMITHKLINE INTELLECTUAL PROPERTY (NO 2) LTDPriority: Aug 9, 2013Filed: Aug 8, 2014Published: Sep 1, 2016
Est. expiryAug 9, 2033(~7.1 yrs left)· nominal 20-yr term from priority
A61P 31/04A61P 43/00A61P 35/00A61P 31/06A61P 15/00A61P 17/00A61P 11/00A61P 21/00C07F 5/04A61K 31/69A61K 45/06C07F 5/025A61P 1/04
61
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Claims

Abstract

Compounds of Formula II, wherein X is selected from chloro, fluoro, bromo and iodo, R 1 and R 2 are each independently selected from H, —CH 3 , —CH 2 CH 3 , —CH 2 CH 2 CH 3 , or —CH(CH 3 ) 2 ; compositions containing them, their use in therapy, including their use as anti-mycobacterial agents, for example in the treatment of a mycobacterial infection in a mammal, and methods for the preparation of such compounds, are provided.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A compound having a structure as shown in Formula II: 
       
         
           
           
               
               
           
         
         wherein X is selected from fluoro, chloro, bromo or iodo and R 1  and R 2  are each independently selected from H, —CH 3 , —CH 2 CH 3 , —CH 2 CH 2 CH 3 , and —CH(CH 3 ) 2 ; or a salt thereof. 
       
     
     
         2 . A compound according to  claim 1  or a salt thereof, wherein X is chloro or bromo. 
     
     
         3 . A compound according to  claim 1 , or a salt thereof, which is 
       
         
           
           
               
               
           
         
       
     
     
         4 . A compound according to  claim 3 , which is 
       
         
           
           
               
               
           
         
       
     
     
         5 . A compound according to  claim 3  which is: 
       
         
           
           
               
               
           
         
       
     
     
         6 . A compound according to  claim 1  which is: 
       
         
           
           
               
               
           
         
       
     
     
         7 . A compound according to  claim 1  which is: 
       
         
           
           
               
               
           
         
       
     
     
         8 . A compound having a structure as shown in Formula IIa: 
       
         
           
           
               
               
           
         
         wherein X is fluoro, chloro, bromo or iodo, and R 1  and R 2  are each independently selected from H, —CH 3 , —CH 2 CH 3 , —CH 2 CH 2 CH 3 , and —CH(CH 3 ) 2 , or a salt thereof. 
       
     
     
         9 . A compound according to  claim 8 , or a salt thereof, which is 
       
         
           
           
               
               
           
         
       
     
     
         10 . A compound according to  claim 8  which is 
       
         
           
           
               
               
           
         
       
     
     
         11 . A compound according to  claim 8  which is 
       
         
           
           
               
               
           
         
       
     
     
         12 . A compound according to  claim 8  which is 
       
         
           
           
               
               
           
         
       
     
     
         13 . A compound according to  claim 8  which is 
       
         
           
           
               
               
           
         
       
     
     
         14 . A compound, (S)-(3-bromo-7,8-dihydro-2H-1,6,9-trioxa-9a-borabenzo[cd]azulen-2-yl)methanamine, having the formula: 
       
         
           
           
               
               
           
         
         or a pharmaceutically acceptable salt thereof. 
       
     
     
         15 . A compound, (S)-(3-chloro-7,8-dihydro-2H-1,6,9-trioxa-9a-borabenzo[cd]azulen-2-yl)methanamine, having the formula: 
       
         
           
           
               
               
           
         
       
     
     
         16 . A compound, (S)-(3-chloro-7,8-dihydro-2H-1,6,9-trioxa-9a-borabenzo[cd]azulen-2-yl)methanamine, having the formula: 
       
         
           
           
               
               
           
         
         or a pharmaceutically acceptable salt thereof. 
       
     
     
         17 . A pharmaceutically acceptable salt of a compound, (S)-(3-chloro-7,8-dihydro-2H-1,6,9-trioxa-9a-borabenzo[cd]azulen-2-yl)methanamine, having the formula: 
       
         
           
           
               
               
           
         
       
     
     
         18 . A pharmaceutical composition comprising a compound, (S)-(3-chloro-7,8-dihydro-2H-1,6,9-trioxa-9a-borabenzo[cd]azulen-2-yl)methanamine, having the formula: 
       
         
           
           
               
               
           
         
         together with at least one pharmaceutically acceptable excipient. 
       
     
     
         19 . A compound, (S)-(3-bromo-8,8-dimethyl-7,8-dihydro-2H-1,6,9-trioxa-9a-borabenzo[cd]azulen-2-yl)methanamine, having the formula: 
       
         
           
           
               
               
           
         
       
     
     
         20 . A compound, (S)-(3-bromo-8,8-dimethyl-7,8-dihydro-2H-1,6,9-trioxa-9a-borabenzo[cd]azulen-2-yl)methanamine, having the formula: 
       
         
           
           
               
               
           
         
         or a pharmaceutically acceptable salt thereof. 
       
     
     
         21 . A pharmaceutically acceptable salt of a compound, (S)-(3-bromo-8,8-dimethyl-7,8-dihydro-2H-1,6,9-trioxa-9a-borabenzo[cd]azulen-2-yl)methanamine, having the formula: 
       
         
           
           
               
               
           
         
       
     
     
         22 . A pharmaceutical composition comprising a compound, (S)-(3-bromo-8,8-dimethyl-7,8-dihydro-2H-1,6,9-trioxa-9a-borabenzo[cd]azulen-2-yl)methanamine, having the formula: 
       
         
           
           
               
               
           
         
         together with at least one pharmaceutically acceptable excipient. 
       
     
     
         23 . A compound selected from the group consisting of:
 (3-bromo-7,8-dihydro-2H-1,6,9-trioxa-9a-borabenzo[cd]azulen-2-yl)methanamine;   (S)-(3-bromo-7,8-dihydro-2H-1,6,9-trioxa-9a-borabenzo[cd]azulen-2-yl)methanamine;   (3-chloro-7,8-dihydro-2H-1,6,9-trioxa-9a-borabenzo[cd]azulen-2-yl)methanamine;   (S)-(3-chloro-7,8-dihydro-2H-1,6,9-trioxa-9a-borabenzo[cd]azulen-2-yl)methanamine;   (3-chloro-8-methyl-7,8-dihydro-2H-1,6,9-trioxa-9a-borabenzo[cd]azulen-2-yl)methanamine;   (3-bromo-8-methyl-7,8-dihydro-2H-1,6,9-trioxa-9a-borabenzo[cd]azulen-2-yl)methanamine;   (3-bromo-8,8-dimethyl-7,8-dihydro-2H-1,6,9-trioxa-9a-borabenzo[cd]azulen-2-yl)methanamine;   (S)-(3-bromo-8,8-dimethyl-7,8-dihydro-2H-1,6,9-trioxa-9a-borabenzo[cd]azulen-2-yl)methanamine;   (3-chloro-8,8-dimethyl-7,8-dihydro-2H-1,6,9-trioxa-9a-borabenzo[cd]azulen-2-yl)methanamine;   (S)-(3-chloro-8,8-dimethyl-7,8-dihydro-2H-1,6,9-trioxa-9a-borabenzo[cd]azulen-2-yl)methanamine;   (3-fluoro-7,8-dihydro-2H-1,6,9-trioxa-9a-borabenzo[cd]azulen-2-yl)methanamine; and   (S)-(3-iodo-7,8-dihydro-2H-1,6,9-trioxa-9a-borabenzo[cd]azulen-2-yl)methanamine,   
       or a pharmaceutically acceptable salt thereof. 
     
     
         24 . A compound according to any of  claim 1 ,  8  or  23  wherein the pharmaceutically acceptable salt is selected from a hydrochloride, a hydrobromide, a hydriodide, a nitride, a carbonate, a monohydrogencarbonate, a phosphate, a monohydrogenphosphate, a dihydrogenphosphate, a sulfate, a monohydrogensulfate, a dihydrogensulfate, or a phosphonate salt. 
     
     
         25 . A compound according to  claim 1 ,  8  or  23 , wherein the pharmaceutically acceptable salt is an acetate, a propionate, an isobutyrate, a maleate, a malonate, a benzoate, a succinate, a suberate, a fumarate, a glucaronate, a galacturonate, a lactate, a mandelate, a phthalate, a benzenesulfonate, a p-tolylsulfonate, a citrate, a tartrate, or a methanesulfonate salt. 
     
     
         26 . A compound according to any of  claim 1 ,  8  or  23 , wherein the pharmaceutically acceptable salt is a salt of an amino acid including an arginate or a lysinate salt. 
     
     
         27 . A compound according to  claim 24  wherein the pharmaceutically acceptable salt is a hydrochloride salt or a dihydrogensulfate salt. 
     
     
         28 . A combination comprising:
 a first therapeutic agent, which is a compound of Formula II or Formula IIa, or a pharmaceutically acceptable salt thereof, according to any of  claims 1  through  27 ;   optionally a second therapeutic agent;   optionally a third therapeutic agent;   optionally a fourth therapeutic agent;   optionally a fifth therapeutic agent; and   optionally a sixth therapeutic agent,   
       wherein the optional second, third, fourth, fifth, or sixth therapeutic agent is not a compound of Formula II or Formula IIa. 
     
     
         29 . A combination according to  claim 27 , wherein the optional second, third, fourth, fifth and sixth therapeutic agent is independently selected from isoniazid, rifampin, pyrazinamide, ethambutol, moxifloxacin, rifapentine, clofazimine, bedaquiline (TMC207), nitroimidazo-oxazine PA-824, delamanid (OPC-67683), an oxazolidinone, EMB analogue SQ109, a benzothiazinone, a dinitrobenzamide and an antiviral agent including an antiretroviral agent. 
     
     
         30 . A combination according to  claim 27 , wherein the oxazolidinone is linezolid, tedizolid, radezolid, sutezolid (PNU-100480), or posizolid (AZD-5847). 
     
     
         31 . A combination according to  claim 27 , wherein the optional second, third, fourth, fifth and sixth therapeutic agent is selected from a therapeutic agent approved or recommended for the treatment of tuberculosis. 
     
     
         32 . A combination according to  claim 27 , wherein the antiretroviral agent is zidovudine, didanosine, lamivudine, zalcitabine, abacavir, stavudine, adefovir, adefovir dipivoxil, fozivudine, todoxil, emtricitabine, alovudine, amdoxovir, elvucitabine, nevirapine, delavirdine, efavirenz, loviride, immunocal, oltipraz, capravirine, lersivirine, GSK2248761, TMC-278, TMC-125, etravirine, saquinavir, ritonavir, indinavir, nelfinavir, amprenavir, fosamprenavir, brecanavir, darunavir, atazanavir, tipranavir, palinavir, lasinavir, enfuvirtide, T-20, T-1249, PRO-542, PRO-140, TNX-355, BMS-806, BMS-663068 and BMS-626529, 5-Helix, raltegravir, elvitegravir, GSK1349572, GSK1265744, vicriviroc (Sch-C), Sch-D, TAK779, maraviroc, TAK449, didanosine, tenofovir, lopinavir, or darunavir. 
     
     
         33 . A pharmaceutical formulation comprising a first therapeutic agent, said first therapeutic agent being a therapeutically effective amount of a compound of Formula II or Formula IIa, or a pharmaceutically acceptable salt thereof, according to any of  claims 1 - 27 ; or a combination according to any of  claims 28 - 32 , and a pharmaceutically acceptable excipient, adjuvant or diluent. 
     
     
         34 . A pharmaceutical formulation according to  claim 33 , further comprising a second therapeutic agent. 
     
     
         35 . A method of killing a mycobacteria and/or inhibiting the replication of mycobacteria that cause disease in an animal, comprising contacting mycobacterial or an animal infected with mycobacteria with a therapeutically effective amount of a compound or a pharmaceutically acceptable salt thereof according to any of  claims 1 - 25 , so as to kill the mycobacteria and/or prevent the replication of the mycobacteria. 
     
     
         36 . A method according to  claim 35 , wherein the mycobacteria is  Mycobacterium tuberculosis.    
     
     
         37 . A method according to  claim 35 , wherein the disease is tuberculosis. 
     
     
         38 . A method according to  claim 35 , wherein the animal is a human. 
     
     
         39 . A method of treating a mycobacterial infection in an animal comprising: administering to the animal any one of: (i) a therapeutically effective amount of a compound of Formula II or Formula IIa, or a pharmaceutically acceptable salt thereof, according to any of  claims 1 - 27 ; (ii) a therapeutically effective amount of a combination according to any of  claims 32 - 35 ; or (iii) a therapeutically effective amount of a pharmaceutical formulation according to any of claims  333 - 34 , so as to treat the mycobacterial infection in the animal. 
     
     
         40 . A method according to  claim 39 , wherein the mycobacterial infection is an infection of a  mycobacterium  selected from  Mycobacterium tuberculosis, Mycobacterium avium  including subspecies (subsp.)  Mycobacterium avium  subsp.  avium, Mycobacterium avium  subsp.  hominissuis, Mycobacterium avium  subsp.  silvaticum , and  Mycobacterium avium  subsp.  paratuberculosis; Mycobacterium kansasii, Mycobacterium malmoense, Mycobacterium simiae, Mycobacterium szulgai, Mycobacterium xenopi, Mycobacterium scrofulaceum, Mycobacterium abscessus, Mycobacterium chelonae, Mycobacterium haemophilum, Mycobacterium leprae, Mycobacterium marinum, Mycobacterium fortuitum, Mycobacterium parafortuitum, Mycobacterium gordonae, Mycobacterium vaccae, Mycobacterium bovis, Mycobacterium bovis  BCG,  Mycobacterium africanum, Mycobacterium canetti, Mycobacterium caprae, Mycobacterium microti, Mycobacterium pinnipedi, Mycobacterium leprae, Mycobacterium ulcerans, Mycobacterium intracellulare, Mycobacterium tuberculosis  complex. (MTC),  Mycobacterium avium  complex (MAC),  Mycobacterium avian - intracellulare  complex (MAIC),  Mycobacterium gordonae  clade;  Mycobacterium kansasii  clade;  Mycobacterium  chelonae clade;  Mycobacterium fortuitum  clade;  Mycobacterium parafortuitum  clade; and  Mycobacterium vaccae  clade. 
     
     
         41 . A method according to  claim 39 , wherein the mycobacteria is  Mycobacterium tuberculosis.    
     
     
         42 . A method according to  claim 39 , wherein the disease is tuberculosis. 
     
     
         43 . A compound of Formula II or Formula IIa according to any of  claims 1 - 27 , or a pharmaceutically acceptable salt thereof, for use in the treatment of a disease resulting from a mycobacterial infection in an animal. 
     
     
         44 . A compound according to  claim 43 , wherein the mycobacterial infection is a  Mycobacterium tuberculosis  infection. 
     
     
         45 . A compound according to  claim 43 , wherein the disease is selected from tuberculosis, leprosy, Johne's disease, Buruli or Bairnsdale ulcer, Crohn's disease, pulmonary disease or pulmonary infection. pneumonia, bursa, synovial, tendon sheaths, localized abscess, lymphadenitis, skin and soft tissue infections Lady Windermere syndrome, MAC lung disease, disseminated  Mycobacterium avium  complex (DMAC), disseminated  Mycobacterium avium intraceullulare  complex (DMAIC), hot-tub lung, MAC mastitis, MAC pyomyositis,  Mycobacterium avum paratuberculosis , or granuloma disease. 
     
     
         46 . A compound according to  claim 45 , wherein the disease is tuberculosis. 
     
     
         47 . A compound according to  claim 43 , wherein the animal is a human. 
     
     
         48 . A use of a compound of Formula II or Formula IIa according to any of  claims 1 - 27 , or a pharmaceutically acceptable salt thereof, in the manufacture of a medicament for the treatment of a mycobacterial infection in an animal. 
     
     
         49 . The use of  claim 48 , wherein the mycobacterial infection is a  Mycobacterium tuberculosis  infection. 
     
     
         50 . The use of  claim 49  wherein the animal is a human. 
     
     
         51 . A method of treating a disease resulting from a mycobacterial infection a mammal, which method comprises administering to the animal in need of such treatment an effective amount of a compound of Formula II or Formula IIa according to any of  claims 1 - 27 , or a pharmaceutically acceptable salt thereof. 
     
     
         52 . A method of treating a disease according to  claim 51 , wherein the mammal is a human. 
     
     
         53 . A method according to  claim 51 , wherein the mycobacterial infection is a  Mycobacterium tuberculosis  infection. 
     
     
         54 . A method according to claim  4951  wherein the disease is selected from tuberculosis, leprosy, Johne's disease, Buruli or Bairnsdale ulcer, Crohn's disease, pulmonary disease or pulmonary infection. pneumonia, bursa, synovial, tendon sheaths, localized abscess, lymphadenitis, skin and soft tissue infections Lady Windermere syndrome, MAC lung disease, disseminated  Mycobacterium avium  complex (DMAC), disseminated  Mycobacterium avium intracellulare  complex (DMAIC), hot-tub lung, MAC mastitis, MAC pyomyositis,  Mycobacterium avum paratuberculosis , or granuloma disease. 
     
     
         55 . A method according to  claim 51 , wherein the disease is tuberculosis. 
     
     
         56 . A method according to  claim 51 , wherein the animal is a human. 
     
     
         57 . A method of treating a mycobacterial infection in an animal, particularly in a mammal, which method comprises administering to the animal in need of such treatment an effective amount of a compound according to any of  claims 1 - 27 , or a pharmaceutically acceptable salt thereof. 
     
     
         58 . A method according to  claim 57 , wherein the mycobacterial infection is a  Mycobacterium tuberculosis  infection. 
     
     
         59 . A method according to  claim 57 , wherein the animal is a human.

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