IP Library Granted Patent US 10,512,656
Granted Patent B2
US 10,512,656 · App. 15/494,136 · Granted Dec 24, 2019

Compositions and methods for the treatment of lysosomal storage disorders and disorders characterized by lysosomal dysfunction

Inventor: Marco Sardiello (Houston, TX)
Assignee: Baylor College of Medicine
A61K31/7016A61K9/0053A61K31/4375A61K31/445A61K45/06
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Quick Facts
Patent No.
US 10,512,656
App. No.
15/494,136
Granted
Dec 24, 2019
Kind
B2
Abstract

The present invention relates to compositions and methods of treating lysosomal storage diseases and methods of using trehalose.

Claims (26)

1. A method of treating juvenile Neuronal Ceroid Lipofuscinosis in a subject in need thereof, the method comprising administering a therapeutically effective amount of a composition comprising a protein kinase B inhibitor.

2. The method of claim 1 , wherein the protein kinase B inhibitor is selected from trehalose and MK-2206.

3. The method of claim 1 , wherein the protein kinase B inhibitor is trehalose.

4. The method of claim 3 , wherein the composition comprises a single active ingredient for inhibiting protein kinase B consisting of trehalose.

5. The method of claim 3 , wherein the composition further comprises a trehalase inhibitor.

6. The method of claim 5 , wherein the trehalase inhibitor is miglustat.

7. The method of claim 6 , wherein the miglustat is administered at a dosage range from about 30 to about 100 mg/Kg, about 100 to about 300 mg/Kg, or about 100 to about 150 mg/Kg.

8. The method of claim 1 , wherein the trehalose is a trehalose analog.

9. The method of claim 8 , wherein the trehalose analog is selected from lentztrehalose A, lentztrehalose B, and lentztrehalose C.

10. The method of claim 3 , wherein the composition is administered parenterally at a per administration dose of between 0.1 g/kg to 1 g/kg trehalose.

11. The method of claim 10 , wherein the administration is completed within less than 120 minutes.

12. The method of claim 6 , wherein the composition is administered parenterally at a per administration dose of between 0.1 g/kg to 1 g/kg trehalose and a per administration dose of the miglustat ranging from about 30 to about 100 mg/Kg, about 100 to about 300 mg/Kg, or about 100 to about 150 mg/Kg.

13. The method of claim 3 , wherein the composition is administered orally at a per administration dose of between 0.1 g/kg to 1 g/kg trehalose.

14. The method of claim 6 , wherein the composition is administered orally at a per administration dose of between 0.1 g/kg to 1 g/kg trehalose and a per administration dose of the miglustat ranging from about 30 to about 100 mg/Kg, about 100 to about 300 mg/Kg, or about 100 to about 150 mg/Kg.

15. The method of claim 3 , wherein the composition is administered once daily.

16. The method of claim 3 , wherein the composition is administered twice daily.

17. The method of claim 1 , wherein the protein kinase B inhibitor is MK-2206.

18. The method of claim 17 , wherein the composition comprises about 30 to about 100 mg MK-2206.

19. The method of claim 17 , wherein the composition comprises about 100 to about 300 mg MK-2206.

20. The method of claim 17 , wherein the composition is administered parenterally.

21. The method of claim 20 , wherein the composition is administered at a per administration dose of about 100 mg/kg to about 150 mg/kg MK-2206.

22. The method of claim 20 , wherein the composition is administered once daily.

23. The method of claim 20 , wherein the composition is administered twice daily.

24. A method of using trehalose, the method comprising inhibiting the activity of a protein kinase B by contacting the protein kinase B with a composition comprising trehalose, wherein the method is used to treat juvenile Neuronal Ceroid Lipofuscinosis.

25. A method of enhancing clearance of undegraded material in a cell exhibiting dysfunctional lysosomal clearance, the method comprising inhibiting a protein kinase B in the cell by contacting the cell with a composition comprising a protein kinase B inhibitor, wherein the protein kinase B inhibitor is MK-2206.

26. A method of treating a lysosomal storage disorder or disorder characterized by lysosomal dysfunction in a subject in need thereof, the method comprising administering a therapeutically effective amount of a composition comprising MK-2206.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 19, 2018
From: SARDIELLO, MARCO
To: BAYLOR COLLEGE OF MEDICINE
Reel/Frame 047232/0071 →
Continuity (3)
Provisional Application 62325535 · Apr 21, 2016
Provisional Application 62475295 · Mar 23, 2017
Related Publication 20170304339A1 · Oct 26, 2017