Oral composition comprising a tnf antagonist and use thereof

Abstract

This application describes a method of delivering a TNF antagonist molecule, in a biologically active form, to a subject in need thereof, the method comprising, orally or mucosally administering to the subject a therapeutically effective amount of a TNF antagonist molecule. This application further describes a method of treating, preventing or reducing the severity of obesity, the method comprising, administering to the subject a therapeutically effective amount of a TNF antagonist molecule.

What is claimed is: 
     
         1 . A method of delivering a TNF antagonist molecule, in a biologically active form, to a subject in need thereof, the method comprising, orally or mucosally administering to the subject a therapeutically effective amount of a TNF antagonist molecule. 
     
     
         2 . A dosage form for delivery of a TNF antagonist to the GI organs of a subject, the dosage form comprising, a therapeutically effective amount of the TNF antagonist. 
     
     
         3 . A method for treating or preventing or reducing the severity of a disease in a subject-in-need thereof, the method comprising orally or mucosally administering to the subject a therapeutically effective amount of a TNF antagonist thereby treating or preventing or reducing the severity of a disease. 
     
     
         4 . The method of  claim 3 , wherein the disease is associated with bacterial translocation. 
     
     
         5 . The method of  claim 4 , wherein the disease is associated with an inflammatory process that is suppressed by induction of systemic regulatory cells. 
     
     
         6 . The method of  claim 3 , wherein the disease is inflammatory bowel disease (IBD), ulcerative colitis (UC) or Crohn's disease (CD). 
     
     
         7 . The method of  claim 3 , wherein the disease is Alzheimer's disease, hepatic encephalopathy, ADHD, metabolic syndrome, diabetes both type 1 and type 2, fatty liver disease, atherosclerosis or chronic fatigue syndrome. 
     
     
         8 . The method of  claim 3 , wherein the disease is Celiac disease, Behchet disease, vasculitis or Whipples disease. 
     
     
         9 . The method of  claim 3 , wherein the disease is a chronic liver disease. 
     
     
         10 . The method of  claim 3 , wherein the disease is NASH or cirrhosis. 
     
     
         11 . The method of  claim 10 , wherein the disease is augmented by bacterial translocation or derangement of gut flora. 
     
     
         12 . A method of treating, preventing or reducing the severity of obesity, the method comprising, administering to the subject a therapeutically effective amount of a TNF antagonist molecule. 
     
     
         13 . The method of  claim 12 , wherein the TNF antagonist molecule is administered parenterally. 
     
     
         14 . The method of  claim 12 , wherein the TNF antagonist molecule is administered orally or mucosally. 
     
     
         15 . A method of treating, reducing or preventing the effect of medicine that causes liver intoxication by administering to the subject in need a therapeutically effective amount of TNF antagonist, thereby treating, reducing or preventing the effect of the medicine that causes liver intoxication. 
     
     
         16 . The method of  claim 15 , wherein the TNF antagonist may be administered sequentially or simultaneously or prior to the addition of the medicine that causes liver intoxication 
     
     
         17 . The method of  claim 15 , wherein, the TNF antagonist is administered parenterally. 
     
     
         18 . The method of  claim 15 , wherein the medicine that causes liver intoxication is acetaminophen. 
     
     
         19 . A method of inducing an overall weight loss in a subject or maintaining a constant weight with a diet enriched in carbohydrates or fats, without changing the eating habits, the method comprising administering to the subject a therapeutically effective amount of a TNF antagonist molecule.