Methods and compositions for treating conditions associated with an abnormal inflammatory responses

Abstract

This disclosure features chemical entities (e.g., a compound exhibiting activity as a mitochondrial uncoupling agent or a pharmaceutically acceptable salt and/or hydrate and/or cocrystal thereof; e.g., a compound, such as niclosamide or a pharmaceutically acceptable salt and/or hydrate and/or cocrystal thereof; e.g., a compound, such as a niclosamide analog, or a pharmaceutically acceptable salt and/or hydrate and/or cocrystal thereof) that are useful, e.g., for treating one or more symptoms of a pathology characterized by an abnormal inflammatory response (e.g., inflammatory bowel diseases) in a subject (e.g., a human). This disclosure also features compositions as well as other methods of using and making the same.

What is claimed is: 
     
         1 . A method for treating a viral infection in a human subject in need thereof, the method comprising administering an effective amount of niclosamide, or a pharmaceutically acceptable salt thereof. 
     
     
         2 . The method of  claim 1 , wherein the viral infection is a coronavirus infection. 
     
     
         3 . The method of  claim 1 , wherein the method comprises locally administering an effective amount of niclosamide, or a pharmaceutically acceptable salt thereof, to the subject. 
     
     
         4 . The method of  claim 1 , wherein the method comprises locally administering an effective amount of niclosamide, or a pharmaceutically acceptable salt thereof, to the gastrointestinal tract of the subject. 
     
     
         5 . The method of  claim 1 , wherein the niclosamide, or a pharmaceutically acceptable salt thereof, is administered by oral administration. 
     
     
         6 . The method of  claim 5 , wherein the niclosamide, or a pharmaceutically acceptable salt thereof, is administered by tablet or pill. 
     
     
         7 . The method of  claim 4 , wherein upon administration, the concentration of niclosamide in the GI tract is higher than the concentration of niclosamide in the plasma compartment. 
     
     
         8 . The method of  claim 1 , wherein the niclosamide, or a pharmaceutically acceptable salt thereof, is administered by inhalation. 
     
     
         9 . The method of  claim 1 , wherein the method further comprises administering a second therapeutic agent to the subject. 
     
     
         10 . The method of  claim 9 , wherein the second therapeutic agent is administered to the subject prior to or after administering the niclosamide, or a pharmaceutically acceptable salt thereof. 
     
     
         11 . The method of  claim 9 , wherein the second therapeutic agent is administered to the subject at about the same time as administering the niclosamide, or a pharmaceutically acceptable salt thereof. 
     
     
         12 . The method of  claim 11 , wherein the second therapeutic agent and the niclosamide, or a pharmaceutically acceptable salt thereof, are provided to the subject simultaneously in the same dosage form. 
     
     
         13 . The method of  claim 11 , wherein the second therapeutic agent and the niclosamide, or a pharmaceutically acceptable salt thereof, are provided to the subject concurrently in separate dosage forms. 
     
     
         14 . The method of  claim 1 , wherein the second therapeutic agent is selected from the group consisting of: chloroquine, hydroxychloroquine, nitazoxanide, penciclovir, ribavirin, ritonavir, colchicine, azithromycin, imatinib, valsartan, famotidine, fluvoxamine, tranexamic acid, telmisartin, ascorbic acid, etoposide, carmostat, and losartan. 
     
     
         15 . The method of  claim 5 , wherein the method comprises orally administering the niclosamide, or a pharmaceutically acceptable salt thereof, as a pharmaceutical composition, wherein the pharmaceutical composition is capable of local delivery to the digestive or GI tract. 
     
     
         16 . The method of  claim 15 , wherein the composition comprises one or more pharmaceutically acceptable excipients that chemically and/or structurally predispose the composition for delivery of niclosamide, or a pharmaceutically acceptable salt thereof, to the colon. 
     
     
         17 . The method of  claim 15 , wherein the composition comprises one or more pharmaceutically acceptable excipients that chemically and/or structurally predispose the composition for delivery of niclosamide, or a pharmaceutically acceptable salt thereof, to the small intestine. 
     
     
         18 . The method of  claim 15 , wherein the composition comprises one or more pharmaceutically acceptable excipients that chemically and/or structurally predispose the composition for delivery of niclosamide, or a pharmaceutically acceptable salt thereof, to the ileum. 
     
     
         19 . The method of  claim 1 , wherein the method comprises administering niclosamide.