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 of treating a lysosomal storage disorder in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of a composition comprising a recombinant glycoprotein, wherein the recombinant glycoprotein is human β-glucuronidase and has a sialylation content of at least 0.7 mol/mol of the recombinant glycoprotein.
2. The method of claim 1 , wherein the subject is a human.
3. The method of claim 1 , wherein the lysosomal storage disorder is mucopolysaccharidosis type 7.
4. The method of claim 1 , wherein the recombinant human β-glucuronidase is administered at a dose of at least about 0.5 mg/kg.
5. The method of claim 1 , wherein the recombinant human β-glucuronidase is administered at a dose of about 1 mg/kg to about 8 mg/kg.
6. The method of claim 1 , wherein the recombinant human β-glucuronidase is administered at a dose of about 2 mg/kg to about 6 mg/kg.
7. The method of claim 1 , wherein the recombinant human β-glucuronidase is administered at a dose of about 4 mg/kg.
8. The method of claim 1 , wherein the recombinant human β-glucuronidase is administered weekly.
9. The method of claim 1 , wherein the recombinant human β-glucuronidase is administered every other week.
10. The method of claim 1 , wherein the recombinant human β-glucuronidase is administered intravenously.
11. The method of claim 1 , wherein the recombinant human β-glucuronidase is administered by continuous infusion.
12. The method of claim 1 , wherein the recombinant human β-glucuronidase is administered concurrently with or following antihistamine therapy.