CN-121985949-A - Aofimod for the treatment of ulcerative colitis

Abstract

The present invention relates to olantimmod or a pharmaceutically acceptable salt thereof for use in the treatment of ulcerative colitis.

Inventors

• P. Ginest
• A. Vician
• M. Mantoko

Assignees

• ABIVAX公司

Dates

Publication Date

20260505

Application Date

20240730

Priority Date

20230801

Claims (20)

1. 1. A therapeutically effective amount of ofatmod or a pharmaceutically acceptable salt thereof for treating moderate to severe active ulcerative colitis in a patient for an initial period of time at an initial dose followed by a subsequent period of time at a subsequent dose.
2. 2. A therapeutically effective amount of ofatmod or a pharmaceutically acceptable salt thereof for use according to claim 1, wherein the initial dose is 50 mg ofatmod, administered once a day.
3. 3. A therapeutically effective amount of ofatmod or a pharmaceutically acceptable salt thereof for use according to claim 1, wherein the initial dose is 25 mg ofatmod, administered once a day.
4. 4. A therapeutically effective amount of ofatmod or pharmaceutically acceptable salt thereof for use according to any one of claims 1 to 3, wherein the initial period of time is at least 8 weeks.
5. 5. A therapeutically effective amount of ofatmod or pharmaceutically acceptable salt thereof for use according to any one of claims 1 to 4, wherein the initial period of time is 8 weeks.
6. 6. A therapeutically effective amount of ofatmod or a pharmaceutically acceptable salt thereof for use according to any one of claims 1 to 5, wherein the subsequent dose is 25 mg ofatmod, administered once daily.
7. 7. A therapeutically effective amount of ofatmod or a pharmaceutically acceptable salt thereof for use according to any one of claims 1 to 5, wherein the subsequent dose is 50 mg ofatmod, administered once daily.
8. 8. A therapeutically effective amount of ofatmod or pharmaceutically acceptable salt thereof for use according to any one of claims 1to 7, wherein the subsequent period of time is at least 44 weeks.
9. 9. A therapeutically effective amount of ofatmod or pharmaceutically acceptable salt thereof for use according to any one of claims 1 to 8, wherein the subsequent period of time is 44 weeks.
10. 10.A therapeutically effective amount of ofatmod or a pharmaceutically acceptable salt thereof for use according to any one of claims 1 to 9, wherein the patient is hyporesponsive, non-responsive, lost responsive or intolerant to conventional therapy and/or advanced therapy for treating moderate to severe active ulcerative colitis.
11. 11. A therapeutically effective amount of ofatmod or a pharmaceutically acceptable salt thereof for use according to claim 10, wherein the conventional therapy is a corticosteroid or immunosuppressant.
12. 12. A therapeutically effective amount of ofatmod or a pharmaceutically acceptable salt thereof for use according to claim 11, wherein the immunosuppressant is selected from azathioprine, 6-mercaptopurine and methotrexate.
13. 13. A therapeutically effective amount of ofatmod or a pharmaceutically acceptable salt thereof for use according to claim 10, wherein the advanced therapy is a biologic, S1P receptor modulator or JAK inhibitor.
14. 14. A therapeutically effective amount of ofatmod or a pharmaceutically acceptable salt thereof for use according to claim 13, wherein the biologic is selected from TNF inhibitors, anti-integrins and anti-IL-23.
15. 15. A therapeutically effective amount of ofatmod or a pharmaceutically acceptable salt thereof for treating moderate to severe active ulcerative colitis in a patient who is either hyporesponsive, nonresponsive, lost responsive or intolerant to conventional therapy and/or advanced therapy for treating moderate to severe active ulcerative colitis.
16. 16. A therapeutically effective amount of ofatmod or a pharmaceutically acceptable salt thereof for use according to claim 15, wherein 50 mg of the afatmod is administered to the patient once a day.
17. 17. A therapeutically effective amount of ofatmod or a pharmaceutically acceptable salt thereof for use according to claim 15, wherein 25mg of afatmod is administered to the patient once daily.
18. 18. A therapeutically effective amount of ofatmod or a pharmaceutically acceptable salt thereof for use according to claim 15, wherein the afatmod or pharmaceutically acceptable salt thereof is administered at an initial dose for an initial period of time followed by subsequent doses for subsequent periods of time.
19. 19. A therapeutically effective amount of ofatmod or a pharmaceutically acceptable salt thereof for use according to claim 18, wherein the initial dose is 50 mg ofatmod, administered once a day.
20. 20. A therapeutically effective amount of ofatmod or a pharmaceutically acceptable salt thereof for use according to claim 18, wherein the initial dose is 25 mg ofatmod, administered once a day.

Description

Aofimod for the treatment of ulcerative colitis Cross Reference to Related Applications The present application claims the benefit of priority from U.S. provisional patent application No. 63/516,910 filed on month 8 and 1 of 2023 and U.S. provisional patent application No. 63/580,823 filed on month 9 and 6 of 2023, each of which is incorporated herein by reference in its entirety. Field of the invention The present invention relates to the use of ofatmod (Obefazimod) (also known as ABX464 or 8-chloro-N- [4- (trifluoromethoxy) phenyl ] quinolin-2-amine or (8-chloro-quinolin-2-yl) - (4-trifluoromethoxy-phenyl) -amine) or a pharmaceutically acceptable salt thereof for the treatment of ulcerative colitis. The present invention relates to olfamod (also known as ABX464 or 8-chloro-N- [4- (trifluoromethoxy) phenyl ] quinolin-2-amine or (8-chloro-quinolin-2-yl) - (4-trifluoromethoxy-phenyl) -amine) or a pharmaceutically acceptable salt thereof for use in the treatment of ulcerative colitis. Background Ulcerative colitis belongs to the group of immune-mediated inflammatory diseases (IMID) and is characterized by a deregulated immune response associated with chronic inflammation of the rectal and colonic mucosal layers and submucosa. The etiology of ulcerative colitis is unknown, but genetic, environmental and immune factors have been thought to contribute to the pathogenesis of IBD. Summary of The Invention Certain dosing regimens of ofatmod have been found to provide advantages in treating patients with ulcerative colitis, including, for example, patients with moderate to severe active ulcerative colitis. Accordingly, in one aspect, the invention provides a method for treating a patient suffering from ulcerative colitis, the method comprising administering to the patient a therapeutically effective amount of ofatmod or a pharmaceutically acceptable salt thereof. Accordingly, in one aspect, the invention provides a therapeutically effective amount of ofatmod or a pharmaceutically acceptable salt thereof for treating ulcerative colitis in a patient. In some embodiments, a patient treated with the provided methods or provided uses suffers from moderate to severe active ulcerative colitis. In some embodiments, the patient is under-responsive, non-responsive, lost responsive, or intolerant to conventional therapy and/or advanced therapy. In some embodiments, the conventional therapy is a corticosteroid or immunosuppressant. In some embodiments, the immunosuppressant is selected from azathioprine, 6-mercaptopurine, and methotrexate. In some embodiments, the advanced therapy is a biologic, S1P receptor modulator, or JAK inhibitor. In some embodiments, the biologic is selected from the group consisting of a TNF inhibitor, an anti-integrin, and an anti-IL-23. In some embodiments, the methods of the invention comprise administering to a patient, an initial dose of ofatmod or a pharmaceutically acceptable salt thereof for an initial period of time followed by a subsequent dose for a subsequent period of time. The present disclosure relates to a therapeutically effective amount of ofatmod or a pharmaceutically acceptable salt thereof for treating moderate to severe active ulcerative colitis in a patient at an initial dose for an initial period of time followed by a subsequent dose for a subsequent period of time. In some embodiments, the initial dose is 50 mg ozagr or a pharmaceutically acceptable salt thereof, once daily. In some embodiments, the initial period of time is 8 weeks. In some embodiments, the subsequent dose is 25 mg ozagr or a pharmaceutically acceptable salt thereof, once daily. In some embodiments, the subsequent period is 44 weeks. Some embodiments of the invention include: Embodiment 1. A therapeutically effective amount of ofatmod or a pharmaceutically acceptable salt thereof for treating moderate to severe active ulcerative colitis in a patient is administered at an initial dose for an initial period of time followed by a subsequent dose for a subsequent period of time. Embodiment 2. A therapeutically effective amount of ofatmod or a pharmaceutically acceptable salt thereof for use according to claim 1, wherein the initial dose is 50mg ofatmod, administered once daily. Embodiment 3. A therapeutically effective amount of ofatmod or a pharmaceutically acceptable salt thereof for use according to claim 1, wherein the initial dose is 25 mg ofatmod, administered once daily. Embodiment 4. A therapeutically effective amount of ofatmod or a pharmaceutically acceptable salt thereof for use according to any one of claims 1 to 3, wherein the initial period of time is at least 8 weeks. Embodiment 5. A therapeutically effective amount of ofatmod or a pharmaceutically acceptable salt thereof for use according to any one of claims 1 to 4, wherein the initial period of time is 8 weeks. Embodiment 6. A therapeutically effective amount of ofatmod or a pharmaceutically acceptable salt thereof for use according to any one of