Compositions comprising 15-ohepa and methods of using the same

Abstract

The present invention relates to the compositions, formulations and methods of treating fatty liver disorders, such as non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) and their sequelae by administration of 15-OHEPA.

1 . A pharmaceutical composition comprising 15-hydroxyeicosapentaenoic acid (15-HEPE) in free acid form or a pharmaceutically acceptable ester, conjugate, or salt thereof, wherein the 15-HEPE comprises at least about 80%, by weight, of all fatty acids present in the pharmaceutical composition. 
     
     
         2 . The pharmaceutical composition of  claim 1 , wherein the pharmaceutical composition comprises 100 mg to 1000 mg of the 15-HEPE. 
     
     
         3 . The pharmaceutical composition of  claim 1 , wherein omega-3 fatty acids other than the 15-HEPE comprise not more than about 10%, by weight, of all fatty acids present in the pharmaceutical composition. 
     
     
         4 . The pharmaceutical composition of  claim 1 , wherein the 15-HEPE is in esterified form. 
     
     
         5 . The pharmaceutical composition of  claim 4 , wherein the esterified form is a C1-C5 alkyl ester. 
     
     
         6 . The pharmaceutical composition of  claim 4 , wherein the esterified form is an ethyl ester. 
     
     
         7 . The pharmaceutical composition of  claim 4 , wherein the esterified form is a triglyceride. 
     
     
         8 . The pharmaceutical composition of  claim 1 , wherein the 15-HEPE is in salt form. 
     
     
         9 . The pharmaceutical composition of  claim 1 , wherein about 500 mg to about 1000 mg of the 15-HEPE is present in a capsule.