Claims for Patent: 12,295,928

Summary for Patent: 12,295,928

Title:	Methods of treatment of cholestatic diseases
Abstract:	The present invention relates to the use of compound 1-[4-methylthiophenyl]-3-[3,5 -dimethyl-4-carboxydimethylmethyloxyphenyl]prop-2-en-1-one (Elafibranor or GFT505) for treating cholestatic diseases, and more specifically PBC and/or PSC.
Inventor(s):	Remy HANF
Assignee:	Genfit SA
Application Number:	US18/506,036
Patent Claims:	1. A method for treating primary biliary cholangitis (PBC) in a subject in need thereof, the method comprising orally administering to the subject a composition comprising elafibranor or a pharmaceutically acceptable salt of elafibranor at a dose between 70 mg and 130 mg per administration, wherein the treatment improves total bilirubin level in said subject. 2. A method for improving total bilirubin level in a subject having primary biliary cholangitis (PBC), the method comprising orally administering to the subject a composition comprising elafibranor or a pharmaceutically acceptable salt of elafibranor at a dose between 70 mg and 130 mg per administration. 3. The method of claim 1, wherein the treatment normalizes bilirubin level in said subject. 4. The method of claim 1, wherein the composition comprises elafibranor. 5. The method of claim 1, wherein said composition is formulated in a form selected from the group consisting of a gel, an oil, a pill, a tablet, a powder, a gel cap, a capsule, and a galenic form or device assuring a prolonged and/or slow release. 6. The method of claim 5, wherein said composition is formulated in a form of a tablet. 7. The method of claim 1, wherein elafibranor is administered once a day. 8. The method of claim 1, wherein the administration dose is 80 mg per administration. 9. The method of claim 1, wherein the administration dose is 120 mg per administration. 10. The method of claim 1, wherein the subject having primary biliary cholangitis (PBC) has an inadequate response to ursodeoxycholic acid. 11. The method of claim 1, the method comprising further administering to the subject in need thereof another anti-cholestatic agent. 12. The method of claim 11, wherein the other anti-cholestatic agent is ursodeoxycholic acid (UDCA). 13. The method according to claim 1, the method comprising orally administering elafibranor at a dose of 80 mg per administration and ursodeoxycholic acid (UDCA), to the subject in need thereof. 14. The method according to claim 1, the method comprising orally administering elafibranor at a dose of 80 mg per administration and ursodeoxycholic acid (UDCA), to a subject having primary biliary cholangitis (PBC) and an inadequate response to UDCA. 15. The method of claim 2, wherein the treatment normalizes bilirubin level in said subject. 16. The method of claim 2, wherein the composition comprises elafibranor. 17. The method of claim 2, wherein said composition is formulated in a form selected from the group consisting of a gel, an oil, a pill, a tablet, a powder, a gel cap, a capsule, and a galenic form or device assuring a prolonged and/or slow release. 18. The method of claim 17, wherein said composition is formulated in a form of a tablet. 19. The method of claim 2, wherein elafibranor is administered once a day. 20. The method of claim 2, wherein the administration dose is of 80 mg per administration. 21. The method of claim 2, wherein the administration dose is of 120 mg per administration. 22. The method of claim 2, wherein the subject having primary biliary cholangitis (PBC) has an inadequate response to ursodeoxycholic acid. 23. The method of claim 2, further comprising administering to the subject another anti-cholestatic agent. 24. The method of claim 23, wherein the other anti-cholestatic agent is ursodeoxycholic acid (UDCA). 25. The method according to claim 2, the method comprising orally administering elafibranor at a dose of 80 mg per administration and ursodeoxycholic acid (UDCA), to the subject in need thereof. 26. The method according to claim 2, the method comprising orally administering elafibranor at a dose of 80 mg per administration and ursodeoxycholic acid (UDCA), to a subject having primary biliary cholangitis (PBC) and an inadequate response to UDCA.