Claims for Patent: 11,071,742

Summary for Patent: 11,071,742

Title:	Compositions for improving cell viability and methods of use thereof
Abstract:	This invention relates to methods and compositions for use improving cell viability, particularly neural cell viability, and more particularly to methods and compositions for use improving cell viability by reducing reactive oxygen metabolite-mediated oxidative damage in a cell, regulating redox homeostasis in a cell, or reducing mitochondrial dysfunction in a cell. The invention further relates to the administration of the bile acid tauroursodeoxycholic acid (TUDCA) in combination with phenylbutyric Acid (PBA) to improve cell viability, and treat at least one symptom associated with, prevent the time of onset of, or slow the development of a disease related to oxidative stress.
Inventor(s):	Cohen Joshua, Klee Justin
Assignee:	Amylyx Pharmaceuticals Inc.
Application Number:	US16280861
Patent Claims:	1. A composition for treating a neurodegenerative disease in a subject , comprising:about 0.5 g to about 1.5 g of tauroursodeoxycholic acid (TUDCA), or a pharmaceutically acceptable salt thereof; andabout 2.5 g to about 3.5 g of 4-phenylbutyric acid (4-PBA), or a pharmaceutically acceptable salt thereof.2. The composition of claim 1 , wherein the composition comprises about 1 g of TUDCA and about 3 g of sodium phenylbutyrate.3. The composition of claim 1 , further comprising a pharmaceutically acceptable carrier.4. The composition of claim 1 , wherein the composition is in the form of a powder claim 1 , capsule claim 1 , tablet claim 1 , emulsion claim 1 , aqueous suspension claim 1 , dispersion claim 1 , or solution.5. A pharmaceutical composition for treating a neurodegenerative disease in a subject claim 1 , comprising:about 10 mg/kg to about 50 mg/kg of the subject's body weight of tauroursodeoxycholic acid (TUDCA), or a pharmaceutically acceptable salt thereof; andabout 10 mg/kg to about 400 mg/kg of the subject's body weight of 4-phenylbutyric acid (4-PBA), or a pharmaceutically acceptable salt thereof.6. The pharmaceutical composition of claim 5 , wherein the composition comprises about 10 mg/kg to about 30 mg/kg of body weight of TUDCA claim 5 , or a pharmaceutically acceptable salt thereof.7. The pharmaceutical composition of claim 5 , wherein the composition comprises about 10 mg/kg to about 100 mg/kg of body weight of 4-PBA claim 5 , or a pharmaceutically acceptable salt thereof.8. The pharmaceutical composition of claim 7 , wherein the composition comprises about 30 mg/kg to about 100 mg/kg of body weight of 4-PBA claim 7 , or a pharmaceutically acceptable salt thereof.9. The pharmaceutical composition of claim 5 , wherein the composition comprises about 10 mg/kg of body weight of TUDCA claim 5 , or a pharmaceutically acceptable salt thereof.10. The pharmaceutical composition of claim 5 , wherein the composition comprises about 15 mg/kg of body weight of TUDCA claim 5 , or a pharmaceutically acceptable salt thereof.11. The pharmaceutical composition of claim 5 , wherein the composition comprises about 20 mg/kg of body weight of TUDCA claim 5 , or a pharmaceutically acceptable salt thereof.12. The pharmaceutical composition of claim 5 , wherein the composition comprises about 30 mg/kg of body weight of TUDCA claim 5 , or a pharmaceutically acceptable salt thereof.13. The pharmaceutical composition of claim 5 , wherein the composition comprises about 40 mg/kg of body weight of TUDCA claim 5 , or a pharmaceutically acceptable salt thereof.14. The pharmaceutical composition of claim 5 , wherein the composition comprises about 50 mg/kg of body weight of TUDCA claim 5 , or a pharmaceutically acceptable salt thereof.15. The pharmaceutical composition of claim 5 , wherein the composition comprises about 10 mg/kg of body weight of 4-PBA claim 5 , or a pharmaceutically acceptable salt thereof.16. The pharmaceutical composition of claim 5 , wherein the composition comprises about 30 mg/kg of body weight of 4-PBA claim 5 , or a pharmaceutically acceptable salt thereof.17. The pharmaceutical composition of claim 5 , wherein the composition comprises about 50 mg/kg of body weight of 4-PBA claim 5 , or a pharmaceutically acceptable salt thereof.18. The pharmaceutical composition of claim 5 , wherein the composition comprises about 100 mg/kg of body weight of 4-PBA claim 5 , or a pharmaceutically acceptable salt thereof.19. The pharmaceutical composition of claim 5 , wherein the composition comprises about 200 mg/kg of body weight of 4-PBA claim 5 , or a pharmaceutically acceptable salt thereof.20. The pharmaceutical composition of claim 5 , wherein the composition comprises about 400 mg/kg of body weight of 4-PBA claim 5 , or a pharmaceutically acceptable salt thereof.21. The pharmaceutical composition of claim 5 , wherein the composition is in the form of a powder claim 5 , capsule claim 5 , tablet claim 5 , emulsion claim 5 , aqueous suspension claim 5 , dispersion claim 5 , or solution.22. A composition for treating a neurodegenerative disease in a subject claim 5 , comprising:tauroursodeoxycholic acid (TUDCA), or a pharmaceutically acceptable salt thereof; and4-phenylbutyric acid (4-PBA), or a pharmaceutically acceptable salt thereof,wherein the bile acid TUDCA or a pharmaceutically acceptable salt thereof and the 4-PBA or a pharmaceutically acceptable salt thereof have a ratio by weight of about 1:3.23. The composition of claim 22 , wherein the composition is in the form of a powder claim 22 , capsule claim 22 , tablet claim 22 , emulsion claim 22 , aqueous suspension claim 22 , dispersion claim 22 , or solution.24. The pharmaceutical composition of claim 5 , wherein the composition comprises about 10 mg/kg to about 30 mg/kg of body weight of tauroursodeoxycholic acid (TUDCA) or a pharmaceutically acceptable salt thereof claim 5 , and about 30 mg/kg to about 100 mg/kg of body weight of 4-PBA or a pharmaceutically acceptable salt thereof.25. The composition of claim 1 , wherein the composition comprises about 0.7 g-1.3 g of TUDCA or a pharmaceutically acceptable salt thereof.26. The composition of claim 1 , wherein the composition comprises about 2.7 g-3.3 g of 4-PBA or a pharmaceutically acceptable salt thereof.