Collagen 7 compositions and methods of using the same
The present disclosure relates to compositions comprising collagen 7 and methods of using the same to treat DEB.
1. A composition comprising recombinant collagen 7, 10 mM sodium phosphate, 5 mM sodium citrate, 70 mM sodium chloride, 75 mM to 100 mM arginine, 50 mM sucrose, and 0.05% polysorbate 20.
2. The composition of claim 1 , wherein the composition has a pH of between 7.0-7.2.
3. The composition of claim 1 , wherein the recombinant collagen 7 is human collagen 7.
4. A pharmaceutical composition comprising recombinant collagen 7, 10 mM sodium phosphate, 5 mM sodium citrate, 70 mM sodium chloride, 75 mM to 100 mM arginine, 50 mM sucrose, and 0.05% polysorbate 20 and one or more pharmaceutically acceptable excipients.
5. The composition of claim 4 , wherein the composition has a pH of between 7.0-7.2.
6. The composition of claim 4 , wherein the recombinant collagen 7 is human collagen 7.
7. The composition of claim 6 , wherein the composition is stable for:
(a) 3 months at −65±5° C., or −20±5° C., when 500 mL of the composition is stored in a 1 liter polycarbonate bottle;
(b) 6 months at −65±5° C., or −20±5° C., when 5.5 mL of the composition is stored in a 10 glass vial;
(c) 2 weeks at 20±5° C.; and/or
(d) up to 1 month at 5±3° C.
8. The composition of claim 6 , for use in the treatment of dystrophic epidermolysis bullosa.
9. A method of treating dystrophic epidermolysis bullosa, comprising administering to a subject in need thereof an effective amount of a composition comprising recombinant collagen 7, 10 mM sodium phosphate, 5 mM sodium citrate, 70 mM sodium chloride, 75 mM to 100 mM arginine, 50 mM sucrose, and 0.05% polysorbate 20, wherein the administration is through intravenous injection.
10. The composition of claim 2 , wherein the recombinant collagen 7 is human collagen 7.
11. The composition of claim 5 , wherein the recombinant collagen 7 is human collagen 7.
12. The method of claim 9 , wherein the recombinant collagen 7 is human collagen 7.
13. The method of claim 9 , wherein the composition has a pH between 7.0-7.2.
14. The method of claim 13 , wherein the composition is stable for:
(a) 3 months at −65±5° C., or −20±5° C., when 500 mL of the composition is stored in a 1 liter polycarbonate bottle;
(b) 6 months at −65±5° C., or −20±5° C., when 5.5 mL of the composition is stored in a 10 glass vial;
(c) 2 weeks at 20±5° C.; and/or
(d) up to 1 month at 5±3° C.
15. The composition of claim 2 or 5 , wherein the composition comprises recombinant collagen 7, 10 mM sodium phosphate, 5 mM sodium citrate, 70 mM sodium chloride, 100 mM arginine, 50 mM sucrose and 0.05% polysorbate 20, and wherein the composition has a pH of 7.1 or 7.2.
16. The method of claim 13 , wherein the composition has a pH 7.1 or 7.2.
17. The composition of claim 15 , wherein the composition comprises recombinant collagen 7 at 1.0 to 4.0 mg/mL.
18. The method of claim 9 , wherein the composition comprises recombinant collagen 7 at 1.0 to 4.0 mg/mL.