Claims for Patent: 12,310,935

Summary for Patent: 12,310,935

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:	US18/505,898
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 at least one element selected from the group consisting of ALP level, γ-GT level, total bilirubin level, ALB level, C4 level, lipid parameters, and pruritus. 2. The method of claim 1, wherein the improvement is at least one selected from the group consisting of reducing ALP level by at least 15% or by at least 40%, reducing ALP level lower than 2×ULN (upper limit of normal) or lower than 1.67×ULN, reducing total bilirubin level lower than 0.4 mg/dL, reducing γ-GT level, improving ALB level, improving C4 level, improving lipid parameters, and improving pruritus. 3. The method of claim 1, wherein the treatment reduces ALP level by at least 15%, reduces ALP level lower than 1.67×ULN (upper limit of normal), and/or reduces total bilirubin level lower than or equal to ULN. 4. The method of claim 1, wherein the treatment normalizes ALP, albumin, and/or bilirubin levels. 5. The method of claim 1, wherein the composition comprises elafibranor. 6. 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. 7. The method of claim 6, wherein said composition is formulated in a form of a tablet. 8. The method of claim 1, wherein elafibranor is administered once a day. 9. The method of claim 1, wherein the administration dose is 80 mg per administration. 10. The method of claim 1, wherein the administration dose is 120 mg per administration. 11. The method of claim 1, wherein the subject has primary biliary cholangitis (PBC) and an inadequate response to ursodeoxycholic acid. 12. The method of claim 1, further comprising administering to the subject in need thereof another anti-cholestatic agent. 13. The method of claim 12, wherein the other anti-cholestatic agent is ursodeoxycholic acid (UDCA). 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 the subject. 15. 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 ursodeoxycholic acid. 16. 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 increases event-free survival (EFS) of the subject by reducing one or more of: a) ALP level by at least 15% or below 1.67×ULN (upper limit of normal), b) TB level within normal limit or below 0.4 mg/dL; c) pruritus score as measured by 5D-itch scale; d) AST, ALT and/or C4 level(s), wherein the reduction is compared to the time of first administration of said composition. 17. The method of claim 16, wherein the treatment increases event-free survival (EFS) of the subject by: a) reducing ALP level by at least 15%; b) reducing ALP level below 1.67×ULN (upper limit of normal), and c) reducing TB level within normal limit. 18. The method of claim 16, wherein the composition comprises elafibranor. 19. The method of claim 16, 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. 20. The method of claim 19, wherein said composition is formulated in a form of a tablet. 21. The method of claim 16, wherein elafibranor is administered once a day. 22. The method of claim 16, wherein the administration dose is of 80 mg per administration. 23. The method of claim 16, wherein the administration dose is of 120 mg per administration. 24. The method of claim 16, wherein the subject in need thereof has primary biliary cholangitis (PBC) and an inadequate response to ursodeoxycholic acid. 25. The method of claim 16, further comprising administering to the subject in need thereof another anti-cholestatic agent. 26. The method of claim 25, wherein the other anti-cholestatic agent is ursodeoxycholic acid (UDCA). 27. The method according to claim 16, the method comprising orally administering elafibranor at a dose of 80 mg per administration and ursodeoxycholic acid (UDCA), to the subject in need thereof. 28. The method according to claim 16, 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.