IP Library Granted Patent US 11,234,973
Granted Patent B2
US 11,234,973 · App. 16/514,167 · Granted Feb 1, 2022

Use of pridopidine for the treatment of fragile X syndrome

Inventors: Michael Hayden (Herzliya, IL); Mahmoud Abdulhossein Pouladi (Singapore, SG)
Assignees: PRILENIA NEUROTHERAPEUTICS LTD.; NATIONAL UNIVERSITY OF SINGAPORE; Agency for Science, Technology and Research
A61K31/451A61K9/0053A61P43/00A61K45/06
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Quick Facts
Patent No.
US 11,234,973
App. No.
16/514,167
Granted
Feb 1, 2022
Kind
B2
Abstract

The invention provides a method of treating a subject afflicted with fragile X syndrome (FXS) or a FXS related disorder, comprising periodically administering to the subject a pharmaceutical composition comprising an amount of pridopidine effective to treat the subject.

Claims (17)

1. A method of treating a subject afflicted with fragile X syndrome (FXS), comprising administering to the subject a pharmaceutical composition comprising an amount of pridopidine or pharmaceutical acceptable salt thereof, effective to treat the subject.

2. The method of claim 1 , wherein the subject is also afflicted with autism spectrum disorder (ASD).

3. The method of claim 1 , wherein the amount of pridopidine is effective to reduce the severity of one or more symptoms of FXS in the subject.

4. The method of claim 3 , wherein the one or more symptoms are selected from the group consisting of cognitive impairment, developmental delays, social and behavior problems, anxiety, hyperactive behavior, hypersensitivity to sensory stimuli, altered gastrointestinal function, and seizures.

5. The method of claim 4 , wherein the symptom is cognitive impairment and the cognitive impairment is an intellectual disability or a learning disability.

6. The method of claim 4 , wherein the symptom is developmental delays which are development delays of speech and language.

7. The method of claim 1 , wherein between 10-315 mg pridopidine is administered to the patient per day.

8. The method of claim 7 , wherein the pridopidine is administered once daily.

9. The method of claim 7 , wherein pridopidine is administered more than once daily.

10. The method of claim 9 , wherein the pridopidine is administered twice per day.

11. The method of claim 1 , wherein the subject has more than 200 CGG repeats on the X chromosome.

12. The method of claim 1 , wherein the subject is less than 18 years old.

13. The method of claim 1 , wherein the subject is human.

14. The method of claim 1 , wherein the administration is oral.

15. The method of claim 1 , wherein the pridopidine is in the form of pridopidine hydrochloride, hydrobromide, nitrate, perchlorate, phosphate, sulphate, formate, acetate, aconate, ascorbate, benzenesulphonate, benzoate, cinnamate, citrate, embonate, enantate, fumarate, glutamate, glycolate, lactate, maleate, malonate, mandelate, methanesulphonate, naphthalene-2-sulphonate, phthalate, salicylate, sorbate, stearate, succinate, tartrate or toluene-p-sulphonate salt thereof.

16. The method of claim 1 , further comprising the administration of a second pharmaceutical agent selected from the group consisting of Carbamazepine, Valproic acid, Divalproex, Lithium carbonate, Gabapentin, Lamotrigine, Topiramate, Tiagabine, Vigabatrin, Phenobarbital, Primidone, Phenytoin, Methylphenidate, Dextroamphetamine, L-acetylcarnitine, Venlafaxine, Nefazodone, Amantadine, Folic acid, Clonidine, Guanfacine, Fluoxetine, Sertraline, Citalopram, Paroxetine, Fluvoxamine, Risperidone, Quetiapine, Olanzapine, Trazodone, and Melatonin.

17. The method of claim 4 , wherein the developmental delay is due to cognitive impairment, social behavior problems, speech and language delay or combination thereof.

Assignments (4)
CORRECTIVE ASSIGNMENT TO CORRECT THE ADD SECOND ASSIGNEE PREVIOUSLY RECORDED AT REEL: 053463 FRAME: 0950. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT. Recorded Aug 20, 2020
From: POULADI, MAHMOUD ABDULHOSSEIN
To: NATIONAL UNIVERSITY OF SINGAPORE; THE BIOMEDICAL SCIENCES INSTITUTE
Reel/Frame 053599/0017 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 16, 2020
From: THE BIOMEDICAL SCIENCES INSTITUTE
To: AGENCY FOR SCIENCE, TECHNOLOGY AND RESEARCH
Reel/Frame 053506/0500 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 12, 2020
From: HAYDEN, MICHAEL
To: PRILENIA NEUROTHERAPEUTICS LTD.
Reel/Frame 053463/0947 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 12, 2020
From: POULADI, MAHMOUD ABDULHOSSEIN
To: THE BIOMEDICAL SCIENCES INSTITUTE
Reel/Frame 053463/0950 →