Claims for Patent: 11,007,175

Summary for Patent: 11,007,175

Title:	Methods of treating conditions related to the S1Preceptor
Abstract:	Provided are methods of treatment of a sphingosine 1-phosphate subtype 1 (S1P) receptor-associated disorder comprising prescribing and/or administering to an individual in need thereof a standard dose of (R)-2-(7-(4-cyclopentyl-3-(trifluoro-methyl)benzyloxy)-1,2,3,4-tetrahydrocyclopenta[b]indol-3-yl)acetic acid (Compound 1), or a pharmaceutically acceptable salt, hydrate, or solvate thereof, in an amount equivalent to about 1.5 to about 2.5 mg of Compound 1, for example, a disease or disorder mediated by lymphocytes, an autoimmune disease or disorder, an inflammatory disease or disorder, ankylosing spondylitis, biliary cirrhosis, cancer, psoriasis, psoriatic arthritis, rheumatoid arthritis, Crohn's disease, transplant rejection, multiple sclerosis, systemic lupus erythematosus, inflammatory bowel disease, ulcerative colitis, type I diabetes, hypertensive nephropathy, glomerulosclerosis, myocardial ischemia-reperfusion injury, and acne.
Inventor(s):	Glicklich Alan, Kam Maria Matilde Sanchez, Shanahan William R.
Assignee:	Arena Pharmaceuticals, Inc.
Application Number:	US15541496
Patent Claims:	1. A method of treatment of ulcerative colitis comprising:administering to an individual in need thereof (R)-2-(7-(4-cyclopentyl-3-(trifluoromethyl)benzyloxy)-1,2,3,4-tetrahydrocyclopenta[b]indol-3-yl)acetic acid (Compound 1), or a pharmaceutically acceptable salt, hydrate, or solvate thereof, in an amount equivalent to about 2.0 mg of Compound 1.2. The method of claim 1 , wherein the Compound 1 claim 1 , or a pharmaceutically acceptable salt claim 1 , hydrate claim 1 , or solvate thereof claim 1 , is administered in an amount equivalent to 2.0 mg of Compound 1.3. The method of claim 1 , wherein the Compound 1 claim 1 , or a pharmaceutically acceptable salt claim 1 , hydrate claim 1 , or solvate thereof is administered once daily to the individual.4. The method of claim 1 , wherein the Compound 1 claim 1 , or a pharmaceutically acceptable salt claim 1 , hydrate claim 1 , or solvate thereof claim 1 , is administered orally.5. The method of claim 1 , wherein the Compound 1 claim 1 , or a pharmaceutically acceptable salt claim 1 , hydrate claim 1 , or solvate thereof claim 1 , is formulated as a capsule or tablet suitable for oral administration.6. The method of claim 1 , wherein the Compound 1 claim 1 , or a pharmaceutically acceptable salt claim 1 , hydrate claim 1 , or solvate thereof claim 1 , is selected from:Compound 1;a calcium salt of Compound 1; andan L-arginine salt of Compound 1.7. The method of claim 1 , wherein the Compound 1 claim 1 , or a pharmaceutically acceptable salt claim 1 , hydrate claim 1 , or solvate thereof claim 1 , is an L-arginine salt of Compound 1.8. The method of claim 1 , wherein the Compound 1 claim 1 , or a pharmaceutically acceptable salt claim 1 , hydrate claim 1 , or solvate thereof claim 1 , is an anhydrous claim 1 , non-solvated crystalline form of an L-arginine salt of Compound 1.9. The method of claim 1 , wherein the Compound 1 claim 1 , or a pharmaceutically acceptable salt claim 1 , hydrate claim 1 , or solvate thereof claim 1 , is an anhydrous claim 1 , non-solvated crystalline form of Compound 1.10. A method of treatment of Crohn's disease claim 1 , comprising:administering to an individual in need thereof (R)-2-(7-(4-cyclopentyl-3-(trifluoromethyl)benzyloxy)-1,2,3,4-tetrahydrocyclopenta[b]indol-3-yl)acetic acid (Compound 1), or a pharmaceutically acceptable salt, hydrate, or solvate thereof, in an amount equivalent to about 2.0 mg of Compound 1.11. A method of treatment of inflammatory bowel disease claim 1 , comprising:administering to an individual in need thereof (R)-2-(7-(4-cyclopentyl-3-(trifluoromethyl)benzyloxy)-1,2,3,4-tetrahydrocyclopenta[b]indol-3-yl)acetic acid (Compound 1), or a pharmaceutically acceptable salt, hydrate, or solvate thereof, in an amount equivalent to about 2.0 mg of Compound 1.12. The method of claim 1 , wherein the ulcerative colitis is moderately to severely active ulcerative colitis.13. A method of treatment of ulcerative colitis comprising:administering orally to an individual in need thereof (R)-2-(7-(4-cyclopentyl-3-(trifluoromethyl)benzyloxy)-1,2,3,4-tetrahydrocyclopenta[b]indol-3-yl)acetic acid (Compound 1), or a pharmaceutically acceptable salt thereof, once daily, in an amount equivalent to about 2.0 mg of Compound 1.14. A method of treatment of ulcerative colitis comprising:administering to an individual in need thereof (R)-2-(7-(4-cyclopentyl-3-(trifluoromethyl)benzyloxy)-1,2,3,4-tetrahydrocyclopenta[b]indol-3-yl)acetic acid (Compound 1), or a pharmaceutically acceptable salt thereof, in an amount equivalent to 2.0 mg of Compound 1.15. The method of claim 14 , wherein the Compound 1 claim 14 , or a pharmaceutically acceptable salt thereof is administered once daily to the individual.16. The method of claim 14 , wherein the Compound 1 claim 14 , or a pharmaceutically acceptable salt thereof claim 14 , is administered orally.17. The method of claim 14 , wherein the Compound 1 claim 14 , or a pharmaceutically acceptable salt thereof claim 14 , is formulated as a capsule or tablet suitable for oral administration.18. The method of claim 14 , wherein the Compound 1 claim 14 , or a pharmaceutically acceptable salt thereof claim 14 , is selected from:Compound 1;a calcium salt of Compound 1; andan L-arginine salt of Compound 1.19. The method of claim 14 , wherein the Compound 1 claim 14 , or a pharmaceutically acceptable salt thereof claim 14 , is an L-arginine salt of Compound 1.20. The method of claim 14 , wherein the Compound 1 claim 14 , or a pharmaceutically acceptable salt thereof claim 14 , is an anhydrous claim 14 , non-solvated crystalline form of an L-arginine salt of Compound 1.21. The method of claim 14 , wherein the Compound 1 claim 14 , or a pharmaceutically acceptable salt thereof claim 14 , is an anhydrous claim 14 , non-solvated crystalline form of Compound 1.