Sialylated glycoprotein compositions and uses thereof
The present application relates to sialylated glycoprotein compositions and methods of their use in treating various conditions and disorders.
1. A method for reducing urinary glycosaminoglycan (uGAG) levels in a subject in need thereof, said subject having a lysosomal storage disorder (LDS), comprising administering to the subject a composition comprising a recombinant β-glucuronidase having a sialylation content of at least 0.7 mol/mol.
2. The method of claim 1 , wherein the subject is a human.
3. The method of claim 1 , wherein the recombinant β-glucuronidase is administered at a dose of at least about 0.5 mg/kg.
4. The method of claim 1 , wherein the recombinant β-glucuronidase is administered at a dose of at about 1 mg/kg to about 8 mg/kg.
5. The method of claim 1 , wherein the recombinant β-glucuronidase is administered at a dose of at about 2 mg/kg to about 6 mg/kg.
6. The method of claim 1 , wherein the recombinant β-glucuronidase is administered at a dose of at about 4 mg/kg.
7. The method of claim 1 , wherein the recombinant β-glucuronidase is administered weekly.
8. The method of claim 1 , wherein the recombinant β-glucuronidase is administered every other week.
9. The method of claim 1 , wherein the recombinant β-glucuronidase is administered intravenously.
10. The method of claim 1 , wherein the recombinant β-glucuronidase is administered by continuous infusion.
11. The method of claim 1 , wherein the recombinant β-glucuronidase is administered concurrently with or following antihistamine therapy.
12. The method of claim 1 , wherein the recombinant β-glucuronidase comprises SEQ ID NO: 1.
13. The method of claim 1 , wherein the recombinant β-glucuronidase consists of SEQ ID NO: 1.
14. The method of claim 1 , wherein the recombinant β-glucuronidase has a sialylation content of about 0.8 mol/mol.
15. The method of claim 1 , wherein the recombinant β-glucuronidase has a sialylation content of about 1.0 mol/mol.
16. The method of claim 1 , wherein the recombinant β-glucuronidase has a sialylation content of about 1.2 mol/mol.
17. The method of claim 1 , wherein the recombinant β-glucuronidase has a sialylation content of about 1.0 mol/mol to about 1.2 mol/mol.
18. The method of claim 1 , wherein the LSD is mucopolysaccharidosis type 7.