Granted Patent B2

US 12,357,616 · App. 17/962,714 · Granted Jul 15, 2025

Inventor: Maria Ait-Tihyaty (Montreal, CA)

Assignee: Vanda Pharmaceuticals Inc.

A61K31/426A61P25/28

Abstract

Claims (28)

1. A method of reducing corticosteroid use in a patient with multiple sclerosis (MS), comprising:

at initiation of the method or re-initiation of the method after discontinuation, administering orally once daily 2 mg of ponesimod on days 1 and 2; 3 mg of ponesimod on days 3 and 4; 4 mg of ponesimod on days 5 and 6; 5 mg of ponesimod on day 7; 6 mg of ponesimod on day 8; 7 mg of ponesimod on day 9; 8 mg of ponesimod on day 10; 9 mg of ponesimod on day 11; 10 mg of ponesimod on days 12, 13, and 14, followed by administering 20 mg of ponesimod orally once daily thereafter,

wherein the patient has a baseline expanded disability status scale (EDSS) score of ≤3.5.

2. The method of claim 1 , wherein the MS is relapsing multiple sclerosis.

3. The method of claim 2 , wherein the relapsing multiple sclerosis comprises relapsing-remitting disease, clinically isolated syndrome, or active secondary progressive disease.

4. The method of claim 1 , wherein the patient has had no prior disease modifying treatment (DMT) for multiple sclerosis.

5. The method of claim 1 , wherein the patient has had no prior disease modifying treatment (DMT) for multiple sclerosis within about two years prior to initiation of treatment with ponesimod.

6. The method of claim 1 , wherein the patient has a baseline expanded disability status scale (EDSS) score of ≤3.0.

7. The method of claim 1 , wherein the patient has had no prior disease modifying treatment (DMT) for multiple sclerosis and has a baseline expanded disability status scale (EDSS) score of ≤3.0.

8. The method of claim 1 , wherein the patient has had no prior disease modifying treatment (DMT) for multiple sclerosis within about two years prior to initiation of treatment with ponesimod and has a baseline expanded disability status scale (EDSS) score of ≤3.0.

9. The method of claim 1 , wherein the corticosteroid is glucocorticoid, methylprednisone, or methylprednisone sodium succinate.

10. In a method of treating a patient suffering from multiple sclerosis, the improvement comprising:

selecting as said patient a patient who has a baseline expanded disability status scale (EDSS) score of ≤3.5; and

administering to said patient a dose of ponesimod orally once daily according to an up-titration regimen comprising:

2 mg of ponesimod on days 1 and 2;

3 mg of ponesimod on days 3 and 4;

4 mg of ponesimod on days 5 and 6;

5 mg of ponesimod on day 7;

6 mg of ponesimod on day 8;

7 mg of ponesimod on day 9;

8 mg of ponesimod on day 10;

9 mg of ponesimod on day 11;

10 mg of ponesimod on days 12, 13, and 14; and

20 mg of ponesimod orally once daily thereafter,

wherein the dose of ponesimod is effective to reduce corticosteroid use in said patient.

11. The improvement of claim 10 , wherein the MS is relapsing multiple sclerosis.

12. The improvement of claim 11 , wherein the relapsing multiple sclerosis comprises relapsing-remitting disease, clinically isolated syndrome, or active secondary progressive disease.

13. The improvement of claim 11 , wherein the patient has had no prior disease modifying treatment (DMT) for multiple sclerosis within about two years prior to initiation of treatment with ponesimod.

Assignments (3)

Continuity (2)

References Cited (95)