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Last Updated: June 1, 2024

Claims for Patent: 11,376,244

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Summary for Patent: 11,376,244

Title:	Methods of treating Fabry patients having renal impairment
Abstract:	Provided are methods for treatment of Fabry disease in patients having HEK assay amenable mutations in .alpha.-galactosidase A. Certain methods comprise administering migalastat or a salt thereof every other day, such as administering about 150 mg of migalastat hydrochloride every other day.
Inventor(s):	Castelli; Jeff (New Hope, PA), Benjamin; Elfrida (Millstone Township, NJ)
Assignee:	Amicus Therapeutics, Inc. (Philadelphia, PA)
Application Number:	17/670,095
Patent Claims:	1. A molecule comprising migalastat bound to an .alpha.-galactosidase A protein comprising a HEK assay amenable mutation selected from the group consisting of D33G, L36W, Q57L, M96I, R112G, C174R, M187I, I253S, G258R, G271S/D313Y, D313Y, D322E, G325R, and R356Q. 2. The molecule of claim 1, wherein the mutation is D33G. 3. The molecule of claim 1, wherein the mutation is L36W. 4. The molecule of claim 1, wherein the mutation is Q57L. 5. The molecule of claim 1, wherein the mutation is M96I. 6. The molecule of claim 1, wherein the mutation is R112G. 7. The molecule of claim 1, wherein the mutation is C174R. 8. The molecule of claim 1, wherein the mutation is M187I. 9. The molecule of claim 1, wherein the mutation is I253S. 10. The molecule of claim 1, wherein the mutation is G258R. 11. The molecule of claim 1, wherein the mutation is G271S/D313Y or D313Y. 12. The molecule of claim 1, wherein the mutation is D322E. 13. The molecule of claim 1, wherein the mutation is G325R. 14. The molecule of claim 1, wherein the mutation is R356Q. 15. The molecule of claim 1, wherein the mutation is a disease-causing mutation. 16. An .alpha.-galactosidase A protein having a HEK amenable mutation selected from the group consisting of D33G, L36W, Q57L, M96I, R112G, C174R, M187I, I253S, G258R, G271S/D313Y, D313Y, D322E, G325R, and R356Q, wherein the protein has increased stability as compared to a naturally-occurring .alpha.-galactosidase A protein having the same mutation. 17. The .alpha.-galactosidase A protein of claim 16, wherein the protein is bound to migalastat. 18. The .alpha.-galactosidase A protein of claim 16, wherein the mutation is D33G. 19. The .alpha.-galactosidase A protein of claim 16, wherein the mutation is L36W. 20. The .alpha.-galactosidase A protein of claim 16, wherein the mutation is Q57L. 21. The .alpha.-galactosidase A protein of claim 16, wherein the mutation is M96I. 22. The .alpha.-galactosidase A protein of claim 16, wherein the mutation is R112G. 23. The .alpha.-galactosidase A protein of claim 16, wherein the mutation is C174R. 24. The .alpha.-galactosidase A protein of claim 16, wherein the mutation is M187I. 25. The .alpha.-galactosidase A protein of claim 16, wherein the mutation is I253S. 26. The .alpha.-galactosidase A protein of claim 16, wherein the mutation is G258R. 27. The .alpha.-galactosidase A protein of claim 16, wherein the mutation is G271S/D313Y or D313Y. 28. The .alpha.-galactosidase A protein of claim 16, wherein the mutation is D322E. 29. The .alpha.-galactosidase A protein of claim 16, wherein the mutation is G325R. 30. The .alpha.-galactosidase A protein of claim 16, wherein the mutation is R356Q.

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