IP Library › Granted Patent US 12,564,582
Granted Patent B2
US 12,564,582 · App. 18/489,846 · Granted Mar 3, 2026

Use of pridopidine for treating dystonias

Inventors: Michael Hayden (Yakum, IL); Spyridon Papapetropoulos (Wellesley Hills, MA); Juha-Matti Savola (Reinach, CH); Eli Eyal (Petah-Tikva, IL); Beth Borowsky (Flemington, NJ); Igor D. Grachev (Millstone Township, NJ); Mark Forrest Gordon (New York, NY)
Assignee: PRILENIA NEUROTHERAPEUTICS LTD.
A61K31/451A61K9/0053A61P21/00
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Quick Facts
Patent No.
US 12,564,582
App. No.
18/489,846
Granted
Mar 3, 2026
Kind
B2
Abstract

The invention provides a method of treating a subject afflicted with a dystonia, comprising periodically administering to the subject a pharmaceutical composition comprising an amount of pridopidine effective to treat the subject.

Claims (23)

1 . A method of treating a subject afflicted with severe dystonia comprising periodically administering to the subject a pharmaceutical composition comprising pridopidine or its pharmaceutically acceptable salt, effective to treat the subject, wherein the severe dystonia is a primary dystonia, an isolated dystonia, an early onset generalized dystonia, a secondary dystonia, a focal dystonia, a segmental dystonia, a multifocal dystonia, a hemidystonia, a generalized dystonia, paroxysmal dystonia, Blepharospasm (Benign Essential Blepharospasm[BEB]), Cervical Dystonia (Spasmodic Torticollis[ST]), Acquired Dystonia, Oromandibular Dystonia, Embouchure dystonia, Paroxysmal Dystonia Choreoathetosis, Paroxysmal nonkinesigenic dyskinesia (PKND), Spasmodic Dysphonia (SD), Spasmodic Torticollis (Cervical Dystonia), Tardive Dystonia, writer's Cramp dystonia or any combination thereof and wherein the severe dystonia is measured by Unified Dystonia Rating Scale (UDRS), and the human subject has a UDRS rating of ≥4 for at least one body part; or the severe dystonia is measured by Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) and the human subject has a BFMDRS rating of ≥4 for at least one body part; or the severe dystonia is measured by Unified Huntington's Disease Rating Scale Total Motor Score (UHDRS-TMS-dystonia), and the human subject has a UHDRS-TMS-dystonia rating of ≥4 for at least one body part.

2 . The method of claim 1 , wherein the primary severe dystonia is a primary generalized dystonia.

3 . The method of claim 1 , wherein the primary severe dystonia is a genetic form of primary dystonia.

4 . The method of claim 1 , wherein the severe dystonia is Torsion dystonia-1 (DYT1) dystonia, DYT6 dystonia, or DYT-KMT2B (DYT28) dystonia.

5 . The method of claim 4 , wherein the DYT1 dystonia is postural type dystonia or action type dystonia.

6 . The method of claim 1 , wherein the severe dystonia is a secondary dystonia, wherein the secondary dystonia is Dopa-responsive dystonia, Myoclonus dystonia, X-linked dystonia-parkinsonism, or Rapid-onset dystonia-parkinsonism.

7 . The method of claim 1 , wherein the severe dystonia is action-specific dystonia or a task-specific dystonia.

8 . The method of claim 1 , wherein the severe dystonia is Musician's dystonia.

9 . The method of claim 1 , wherein the severe dystonia is not caused by a pathology.

10 . The method of claim 9 , wherein the pathology is a stroke, a traumatic brain injury, a lesion, a brain tumor, neurological tissue damage, or neurological tissue degeneration.

11 . The method of claim 1 , wherein the subject has been confirmed to be afflicted with DYT1 or other primary genetic forms of dystonia by genetic testing.

12 . The method of claim 1 , wherein the subject has a Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) score greater than 6.

13 . The method of claim 12 , wherein the subject has a 3-base pair in-frame deletion within the coding region of the TOR1A (torsinA) gene located on chromosome 9q34.

14 . The method of claim 1 , wherein the amount of pridopidine is effective to provide a clinically significant improvement in dystonia symptoms.

15 . The method of claim 14 , wherein the clinically significant improvement in dystonia symptoms is an at least a 20% change from baseline in the subject administered pridopidine in comparison to a human patient not treated with pridopidine as measured by the UHDRS-TMS-dystonia scale or the Burke-Fahn-Marsden Dystonia Rating Scale.

16 . The method of claim 1 , wherein the amount of pridopidine is effective to reduce or maintain a level of one or more symptoms of the dystonia in the subject.

17 . The method of claim 16 , wherein the symptoms are measured by the Burke-Fahn-Marsden Dystonia Rating Scale or the Unified Dystonia Rating Scale.

18 . The method of claim 14 , wherein the one or more symptoms are selected from the group consisting of: involuntary limb movement or muscle contractions; twisted posture of the limbs or trunk; abnormal fixed posture of the limbs or trunk; talipes equinovarus; turning in of the leg; turning in of the arm; tremor of the hand, head, trunk or arms; dragging of the leg; torticollis; writer's cramp; and dystonia of trunk and/or extremities.

19 . The method of claim 1 , wherein 22.5 mg to 315 mg pridopidine is administered to the patient per day.

20 . The method of claim 19 , wherein the pridopidine or its pharmaceutically acceptable salt is in the form of an unit dose and the unit dose is administered once daily.

21 . The method of claim 19 , wherein the unit dose is administered twice per day.

22 . The method of claim 1 , wherein pridopidine or its pharmaceutically acceptable salt is orally administered.

23 . The method of claim 1 , wherein the pridopidine is in the form of pridopidine hydrochloride.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 23, 2023
From: HAYDEN, MICHAEL; PAPAPETROPOULOS, SPYRIDON; SAVOLA, JUHA-MATTI; EYAL, ELI; BOROWSKY, BETH; GRACHEV, IGOR D.; GORDON, MARK FORREST
To: PRILENIA THERAPEUTICS DEVELOPMENT LTD.
Reel/Frame 065652/0620 →
CHANGE OF NAME Recorded Nov 23, 2023
From: PRILENIA THERAPEUTICS DEVELOPMENT LTD.
To: PRILENIA NEUROTHERAPEUTICS LTD.
Reel/Frame 065668/0195 →
CHANGE OF ADDRESS Recorded Nov 23, 2023
From: PRILENIA NEUROTHERAPEUTICS LTD.
To: PRILENIA NEUROTHERAPEUTICS LTD.
Reel/Frame 065668/0222 →
Continuity (5)
Division 16283784 · Feb 24, 2019
Continuation In Part PCTUS2017048458 · Aug 24, 2017
Provisional Application 62395319 · Sep 15, 2016
Provisional Application 62379175 · Aug 24, 2016
Related Publication 20240075021A1 · Mar 7, 2024
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