US2023372361A1PendingUtilityA1

Use of oxygenated cholesterol sulfates for treating inflammatory conditions

Assignee: DURECT CORPPriority: Jun 26, 2020Filed: Jun 25, 2021Published: Nov 23, 2023
Est. expiryJun 26, 2040(~13.9 yrs left)· nominal 20-yr term from priority
A61K 31/575A61P 29/00A61P 35/00A61P 3/10A61P 37/02A61P 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 inflammatory condition, such as at least one of dental pulp inflammation, periodontal disease, skin inflammation, psoriasis, ulcerative colitis, osteoarthritis, inflammatory bowel disease (IBD), Crohn's disease, irritable bowel syndrome (IBS), Alzheimer's disease, Parkinson's disease, pancreatitis (acute and/or chronic), hepatitis (viral and/or non-viral), atherosclerosis, myocarditis, idiopathic pulmonary disorder (IPD), chronic obstructive pulmonary disorder (COPD), pneumonia, chronic inflammatory lung disease, bronchitis, asthma, chronic kidney disease (CKD), nephritis, sepsis, ankylosing spondylitis, diverticulitis, and fibromyalgia. In some cases, the at least one inflammatory condition is associated with Epstein-Ban 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 inflammatory 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-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,   wherein the at least one inflammatory condition is optionally associated with Epstein-Barr virus infection.   
     
     
         2 . The method of  claim 1 , wherein the at least one inflammatory condition is associated with Epstein-Barr virus infection. 
     
     
         3 . The method of  claim 1 , wherein the at least one inflammatory condition comprises at least one of dental pulp inflammation, periodontal disease, skin inflammation, psoriasis, ulcerative colitis, osteoarthritis, inflammatory bowel disease (IBD), Crohn's disease, irritable bowel syndrome (IBS), Alzheimer's disease, Parkinson's disease, pancreatitis (acute and/or chronic), hepatitis (viral and/or non-viral), atherosclerosis, myocarditis, idiopathic pulmonary disorder (IPD), chronic obstructive pulmonary disorder (COPD), pneumonia, chronic inflammatory lung disease, bronchitis, asthma, chronic kidney disease (CKD), nephritis, sepsis, ankylosing spondylitis, diverticulitis, and fibromyalgia. 
     
     
         4 . The method of  claim 1 , wherein the at least one inflammatory condition comprises psoriasis associated with Epstein-Barr virus infection. 
     
     
         5 . The method of  claim 1 , wherein the method comprises administering to the subject an effective amount of 25-hydroxycholesterol-3-sulfate (25HC3 S) or salt thereof. 
     
     
         6 . The method of  claim 1 , 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.   
     
     
         7 . The method of  claim 1 , wherein the administering is performed from once to 3 times per day. 
     
     
         8 . The method of  claim 1 , 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. 
     
     
         9 . The method of  claim 1 , wherein the administering comprises administering a pharmaceutical composition comprising the at least one compound and a physiologically acceptable excipient, diluent, or carrier. 
     
     
         10 . The method of  claim 9 , wherein the pharmaceutical composition is formulated in unit dosage form. 
     
     
         11 . The method of  claim 9 , wherein the pharmaceutical composition is in solid form. 
     
     
         12 . The method of  claim 9 , 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. 
     
     
         13 . The method of  claim 9 , wherein the pharmaceutical composition comprises a carrier that is a liquid. 
     
     
         14 . The method of  claim 13 , wherein the at least one compound is solubilized in the liquid or dispersed in the liquid. 
     
     
         15 . The method of  claim 13 , wherein: (a) the liquid is aqueous; or (b) the liquid is sterile water for injections or phosphate-buffered saline. 
     
     
         16 . The method of  claim 9 , wherein the pharmaceutical composition is in a sealed vial, ampoule, syringe, or bag.

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