US2023293551A1PendingUtilityA1

Use of oxygenated cholesterol sulfates for treating autoimmune conditions

Assignee: DURECT CORPPriority: Jun 26, 2020Filed: Jun 25, 2021Published: Sep 21, 2023
Est. expiryJun 26, 2040(~13.9 yrs left)· nominal 20-yr term from priority
A61K 31/575A61P 35/00A61P 3/10A61P 37/02A61P 29/00A61P 25/28A61P 25/30A61P 25/32A61P 25/36A61P 25/00A61P 25/16A61P 25/18A61P 25/24
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Claims

Abstract

Aspects of the present disclosure include methods for treating at least one autoimmune condition, such as at least one of hepatitis, multiple sclerosis, systemic lupus erythematosus, and rheumatoid arthritis. In some cases, the at least one autoimmune condition is associated with Epstein-Barr virus infection. In practicing the subject methods, an effective amount of at least one compound selected from 25-hydroxycholesterol-3-sulfate (25HC3S), 25-hydroxycholesterol-disulfate (25HCDS), 27-hydroxycholesterol-3-sulfate (27HC3S), 27-hydroxycholesterol-disulfate (27HCDS), 24-hydroxycholesterol-3-sulfate (24HC3S), 24-hydroxycholesterol-disulfate (24HCDS), and 24,25-epoxycholesterol-3-sulfate, or salt thereof is administered to the subject.

Claims

exact text as granted — not AI-modified
1 . A method of treating at least one autoimmune condition in a subject in need thereof, comprising:
 administering to the subject an effective amount of at least one compound selected from 25-hydroxycholesterol-3-sulfate (25HC3S), 25-hydroxycholesteroldisulfate (25HCDS), 27-hydroxycholesterol-3-sulfate (27HC3S), 27-hydroxycholesteroldisulfate (27HCDS), 24-hydroxycholesterol-3-sulfate (24HC3S), 24-hydroxycholesteroldisulfate (24HCDS), and 24,25-epoxycholesterol-3-sulfate, or salt thereof,   wherein the at least one autoimmune condition is optionally associated with Epstein-Barr virus infection.   
     
     
         2 . The method of  claim 1 , wherein the at least one autoimmune condition comprises at least one of hepatitis, multiple sclerosis, systemic lupus erythematosus, and rheumatoid arthritis. 
     
     
         3 . The method of  claim 1 , wherein the at least one autoimmune condition comprises hepatitis. 
     
     
         4 . The method of  claim 1 , wherein the at least one autoimmune condition comprises multiple sclerosis. 
     
     
         5 . The method of  claim 1 , wherein the at least one autoimmune condition comprises systemic lupus erythematosus. 
     
     
         6 . The method of  claim 1 , wherein the at least one autoimmune condition comprises rheumatoid arthritis. 
     
     
         7 . The method of any one of  claims 1 to 6 , wherein the at least one autoimmune condition is associated with Epstein-Barr virus infection. 
     
     
         8 . The method of any one of  claims 1 to 7 , wherein the method comprises administering to the subject an effective amount of 25-hydroxycholesterol-3-sulfate (25HC3S) or salt thereof. 
     
     
         9 . The method of any one of  claims 1 to 8 , wherein the at least one compound is administered in an amount selected from the group consisting of:
 (a) an amount ranging from 0.001 mg/kg/day to 100 mg/kg/day;   (b) an amount ranging from 0.1 mg/kg to 100 mg/kg, based on body mass of the subject; and   (c) an amount ranging from 1 mg/kg to 10 mg/kg, based on body mass of the subject.   
     
     
         10 . The method of any one of  claims 1 to 9 , wherein the administering is performed from once to 3 times per day. 
     
     
         11 . The method of any one of  claims 1 to 10 , wherein the administering comprises at least one of oral administration, enteric administration, sublingual administration, transdermal administration, intravenous administration, peritoneal administration, parenteral administration, administration by injection, subcutaneous injection, and intramuscular injection. 
     
     
         12 . The method of any one of  claims 1 to 11 , wherein the administering comprises administering a pharmaceutical composition comprising the at least one compound and a physiologically acceptable excipient, diluent, or carrier. 
     
     
         13 . The method of  claim 12 , wherein the pharmaceutical composition is formulated in unit dosage form. 
     
     
         14 . The method of  claim 12  or  13 , wherein the pharmaceutical composition is in solid form. 
     
     
         15 . The method of any one of  claims 12 to 14 , wherein the pharmaceutical composition: (a) is in the form of a powder, a tablet, a capsule, or a lozenge; and/or (b) comprises the at least one compound in freeze-dried form together with a bulking agent. 
     
     
         16 . The method of  claim 12  or  13 , wherein the pharmaceutical composition comprises a carrier that is a liquid. 
     
     
         17 . The method of  claim 16 , wherein the at least one compound is solubilized in the liquid or dispersed in the liquid. 
     
     
         18 . The method of  claim 16  or  17 , wherein: (a) the liquid is aqueous; or (b) the liquid is sterile water for injections or phosphate-buffered saline. 
     
     
         19 . The method of any one of  claims 12  and  16 to 18 , wherein the pharmaceutical composition is in a sealed vial, ampoule, syringe, or bag.

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