IP Library › Granted Patent US 12,502,379
Granted Patent B2
US 12,502,379 · App. 17/628,387 · Granted Dec 23, 2025

Ponesimod for avoiding worsening of fatigue-related symptoms in multiple sclerosis patients

Inventors: Michel Burcklen (Allschwil, CH); Tarek El Akkad (Chester, NJ); Brian Hennessy (Allschwil, CH); Andrea Vaclavkova (Allschwil, CH); Alexander Keenan (Raritan, NJ)
Assignee: Vanda Pharmaceuticals Inc.
A61K31/426A61P25/28
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Quick Facts
Patent No.
US 12,502,379
App. No.
17/628,387
Granted
Dec 23, 2025
Kind
B2
Abstract

The disclosure relates to methods of treating multiple sclerosis using Ponesimod. In certain aspects, these include methods of avoiding worsening of fatigue-related symptoms in a human patient who has had no prior disease modifying treatment (DMT) for multiple sclerosis, who has a baseline expanded disability status scale (EDSS) score of ≤3.5, or who does not have Gd+/T1 lesions at baseline.

Claims (27)

1 . A method for avoiding worsening of fatigue-related symptoms in a human patient suffering from multiple sclerosis and fatigue, the method comprising:

assessing the fatigue-related symptoms of the human patient; and

administering to the human patient ponesimod using a regimen that is effective to avoid worsening of the fatigue-related symptoms,

wherein the human patient has received no prior disease modifying treatment (DMT) for multiple sclerosis.

2 . The method of claim 1 , wherein the regimen includes administering about 20 mg of ponesimod orally once daily.

3 . The method of claim 1 , wherein the regimen comprises an up-titration step at initiation of the method or upon re-initiation of the method after a discontinuation, comprising 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; and 9 mg of ponesimod on day 11; 10 mg of ponesimod on days 12, 13, and 14, followed by administering 20 mg of ponesimod once daily thereafter.

4 . The method of claim 1 , wherein the fatigue-related symptoms are assessed using a patient-reported outcome questionnaire.

5 . The method of claim 4 , wherein the questionnaire is the Fatigue Symptoms and Impact Questionnaire-Relapsing Multiple Sclerosis (FSIQ-RMS).

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

7 . The method of claim 6 , wherein the relapsing multiple sclerosis comprises relapsing-remitting multiple sclerosis, clinically isolated syndrome, or active secondary progressive multiple sclerosis.

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

9 . A method for avoiding worsening of fatigue-related symptoms in a human patient suffering from multiple sclerosis and fatigue, the method comprising:

assessing the fatigue-related symptoms of the human patient; and

administering to the human patient ponesimod using a regimen that is effective to avoid worsening of the fatigue-related symptoms,

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

10 . The method of claim 9 , wherein about 20 mg of ponesimod is administered orally once daily.

11 . The method of claim 9 , wherein the regimen comprises an up-titration step at initiation of the method or upon re-initiation of the method after a discontinuation, comprising 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; and 9 mg of ponesimod on day 11; 10 mg of ponesimod on days 12, 13, and 14, followed by administering 20 mg of ponesimod once daily thereafter.

12 . The method of claim 9 , wherein the multiple sclerosis is relapsing multiple sclerosis.

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

14 . A method for avoiding worsening of fatigue-related symptoms in a human patient suffering from multiple sclerosis and fatigue, the method comprising:

assessing the fatigue-related symptoms of the human patient; and

administering to the human patient ponesimod using a regimen that is effective to avoid worsening of the fatigue-related symptoms,

wherein the patient does not have Gd+/T1 lesions at baseline.

15 . The method of claim 14 , wherein about 20 mg of ponesimod is administered orally once daily.

16 . The method of claim 14 , wherein the regimen comprises an up-titration step at initiation of the method or upon re-initiation of the method after a discontinuation, comprising 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; and 9 mg of ponesimod on day 11; 10 mg of ponesimod on days 12, 13, and 14, followed by administering 20 mg of ponesimod once daily thereafter.

17 . The method of claim 14 , wherein the multiple sclerosis is relapsing multiple sclerosis.

18 . The method of claim 17 , wherein the relapsing multiple sclerosis comprises relapsing-remitting disease, clinically isolated syndrome, or active secondary progressive disease.

Assignments (4)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 29, 2024
From: ACTELION PHARMACEUTICALS LTD
To: VANDA PHARMACEUTICALS INC.
Reel/Frame 066276/0577 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 19, 2022
From: BURCKLEN, MICHEL; HENNESSY, BRIAN; VACLAVKOVA, ANDREA
To: ACTELION PHARMACEUTICALS LTD
Reel/Frame 058695/0740 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 19, 2022
From: EL AKKAD, TAREK; KEENAN, ALEXANDER
To: JANSSEN RESEARCH & DEVELOPMENT, LLC
Reel/Frame 058695/0825 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 19, 2022
From: JANSSEN RESEARCH & DEVELOPMENT, LLC
To: ACTELION PHARMACEUTICALS LTD
Reel/Frame 058695/0885 →
Continuity (2)
Provisional Application 62877108 · Jul 22, 2019
Related Publication 20220273623A1 · Sep 1, 2022
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