9-aminomethyl minocycline compounds and uses thereof

Abstract

Methods and compositions for using a tetracycline compound to treat bacterial infections are described. In one embodiment, for example, the invention provides a method of treating a subject for an infection, comprising administering to said subject an effective amount of 9-[(2,2-dimethyl-propyl amino)-methyl]-minocycline or a salt thereof, such that said subject is treated, wherein the 9-[(2,2-dimethyl-propyl amino)-methyl]-minocycline is administered orally at a dose of about 450 mg per day for two consecutive days, then at a dose of about 300 mg per day for 5 or more days.

1 - 10 . (canceled) 
     
     
         11 . A method of treating a human subject in need of treatment for a bacterial skin or skin structure infection, comprising orally administering to said subject an effective amount of 9-[(2,2-dimethyl-propyl amino)-methyl]-minocycline or a salt thereof, such that said subject is treated, wherein said 9-[(2,2-dimethyl-propyl amino)-methyl]-minocycline is administered orally at a dose of about 450 mg per day for two consecutive days, then at a dose of about 300 mg per day for 5 or more days, wherein said bacterial skin or skin structure infection is known or suspected to be caused by Gram-positive pathogens. 
     
     
         12 - 16 . (canceled) 
     
     
         17 . A method of treating a human subject in need of treatment for a bacterial skin or skin structure infection, comprising orally administering to said subject an effective amount of 9-[(2,2-dimethyl-propyl amino)-methyl]-minocycline or a salt thereof, such that said subject is treated, wherein said 9-[(2,2-dimethyl-propyl amino)-methyl]-minocycline is administered orally at a dose of about 450 mg per day for two consecutive days, then at a dose of about 300 mg per day for 5 or more days, wherein said bacterial skin or skin structure infection is a result of vascular insufficiency or edema. 
     
     
         18 . (canceled) 
     
     
         19 . A method of treating a human subject in need of treatment for a bacterial skin or skin structure infection, comprising orally administering to said subject an effective amount of 9-[(2,2-dimethyl-propyl amino)-methyl]-minocycline or a salt thereof, such that said subject is treated, wherein said 9-[(2,2-dimethyl-propyl amino)-methyl]-minocycline is administered orally at a dose of about 450 mg per day for two consecutive days, then at a dose of about 300 mg per day for 5 or more days, wherein each oral dose of said 9-[(2,2-dimethyl-propyl amino)-methyl]-minocycline is administered about 24 hours apart. 
     
     
         20 - 21 . (canceled) 
     
     
         22 . A method of treating a human subject in need of treatment for a bacterial skin or skin structure infection, comprising orally administering to said subject an effective amount of 9-[(2,2-dimethyl-propyl amino)-methyl]-minocycline or a salt thereof, such that said subject is treated, wherein said 9-[(2,2-dimethyl-propyl amino)-methyl]-minocycline is administered orally at a dose of about 450 mg per day for two consecutive days, then at a dose of about 300 mg per day for 5 or more days, wherein said subject is treated for 8 days. 
     
     
         23 - 25 . (canceled) 
     
     
         26 . The method of  claim 11 , wherein said Gram-positive pathogens include  Staphylococcus aureus  that is methicillin-resistant  Staphylococcus aureus  (MRSA), or methicillin-susceptible  Staphylococcus aureus  (MSSA). 
     
     
         27 . The method of  claim 11 , wherein said Gram-positive pathogens include  Streptococcus  species that include  Streptococcus anginosus  group. 
     
     
         28 . The method of  claim 11 , wherein said Gram-positive pathogens include  Streptococcus  species that include beta-hemolytic Streptococci or  S. anginosus.    
     
     
         29 . The method of  claim 11 , wherein said Gram-positive pathogens include  Streptococcus  species that include non-hemolytic Streptococci or  S. intermedius.    
     
     
         30 . The method of  claim 11 , wherein said Gram-positive pathogens include  Streptococcus  species that include alpha-hemolytic Streptococci or  S. constellatus.    
     
     
         31 . The method of  claim 11 , wherein said Gram-positive pathogens include  Enterococcus  species that include  Enterococcus faecalis  (VSE). 
     
     
         32 . The method of  claim 11 , wherein said Gram-positive pathogens include  Streptococcus  species that include  Streptococcus pyogenes.    
     
     
         33 . A method of treating a human subject in need of treatment for a bacterial skin or skin structure infection, comprising orally administering to said subject an effective amount of 9-[(2,2-dimethyl-propyl amino)-methyl]-minocycline or a salt thereof, such that said subject is treated, wherein said 9-[(2,2-dimethyl-propyl amino)-methyl]-minocycline is administered orally at a dose of about 450 mg per day for two consecutive days, then at a dose of about 300 mg per day for 5 or more days, wherein said bacterial skin or skin structure infection is known or suspected to be caused by Gram-negative pathogens. 
     
     
         34 . (canceled) 
     
     
         35 . A method of treating a human subject in need of treatment for a bacterial skin or skin structure infection, comprising orally administering to said subject an effective amount of 9-[(2,2-dimethyl-propyl amino)-methyl]-minocycline or a salt thereof, such that said subject is treated, wherein said 9-[(2,2-dimethyl-propyl amino)-methyl]-minocycline is administered orally at a dose of about 450 mg per day for two consecutive days, then at a dose of about 300 mg per day for 5 or more days, wherein GI adverse events (AEs) associated with treatment are predominantly mild. 
     
     
         36 . A method of treating a human subject in need of treatment for a bacterial skin or skin structure infection, comprising orally administering to said subject an effective amount of 9-[(2,2-dimethyl-propyl amino)-methyl]-minocycline or a salt thereof, such that said subject is treated, wherein said 9-[(2,2-dimethyl-propyl amino)-methyl]-minocycline is administered orally at a dose of about 450 mg per day for two consecutive days, then at a dose of about 300 mg per day for 5 or more days, wherein GI adverse events (AEs) associated with treatment do not result in discontinuation of therapy. 
     
     
         37 - 48 . (canceled)