Claims for Patent: 12,290,566

Summary for Patent: 12,290,566

Title:	Dosing regimens and related compositions and methods
Abstract:	In some aspects, the present invention provides cell-reactive compstatin analogs and compositions comprising cell-reactive compstatin analogs. In some aspects, the invention further provides methods of using cell-reactive compstatin analogs, e.g., treat a complement-mediated disorder, e.g., to inhibit complement-mediated damage to a cell, tissue, or organ. In some aspects, the invention provides long-acting compstatin analogs and compositions comprising long-acting compstatin analogs. In some aspects, the invention further provides methods of using long-acting compstatin analogs, e.g., to treat a complement-mediated disorder, e.g., to inhibit complement-mediated damage to a cell, tissue, or organ. In some aspects, the invention provides targeted compstatin analogs and compositions comprising targeted compstatin analogs. In some aspects, the invention further provides methods of using targeted compstatin analogs, e.g., to treat a complement-mediated disorder, e.g., to inhibit complement-mediated damage to a cell, tissue, or organ.
Inventor(s):	Federico Grossi, Pascal Deschatelets, Cedric Francois, Patrick Johnson, Carolina Vega
Assignee:	Jpharma Solutions GmbH, Apellis Pharmaceuticals Inc
Application Number:	US18/115,744
Patent Claims:	1. A composition comprising: (i) a long-acting compstatin analog (LACA) having a structure: wherein the (CH2CH2O)n moiety has an average molecular weight of about 40,000 Daltons; (ii) a pharmaceutically acceptable carrier; and (iii) sorbitol, wherein the pH of the composition is 5.0. 2. The composition of claim 1, wherein the composition comprises sorbitol at between about 2.5% w/v and about 4.5% w/v. 3. The composition of claim 1, wherein the composition comprises sorbitol at between about 4.0% w/v and about 4.5% w/v. 4. A unit dose comprising the composition of claim 1, wherein the unit dose comprises between about 585 mg and about 2510 mg of the LACA. 5. The unit dose of claim 4, wherein the unit dose comprises between about 900 mg and about 1395 mg of the LACA. 6. The unit dose of claim 4, wherein the unit dose comprises between about 990 mg and about 1215 mg of the LACA. 7. The unit dose of claim 4, wherein the unit dose comprises about 1080 mg of the LACA. 8. A method of treating a subject in need of treatment of a complement-mediated disorder, the method comprising subcutaneously administering to the subject a unit dose comprising the composition of claim 1. 9. The method of claim 8, comprising administering the unit dose twice weekly, wherein the unit dose comprises between about 585 mg and about 2510 mg of the LACA. 10. The method of claim 9, comprising administering the unit dose twice weekly, wherein the unit dose comprises between about 900 mg and about 1395 mg of the LACA. 11. The method of claim 9, comprising administering the unit dose twice weekly, wherein the unit dose comprises between about 990 mg and about 1215 mg of the LACA. 12. The method of claim 9, comprising administering the unit dose twice weekly, wherein the unit dose comprises about 1080 mg of the LACA. 13. A syringe or container comprising the composition of claim 1. 14. The composition of claim 1, wherein the LACA is at a concentration of 54 mg/mL. 15. The composition of claim 1, wherein the composition comprises an acetate buffer. 16. The composition of claim 15, wherein the acetate buffer comprises acetic acid and sodium acetate. 17. The composition of claim 1, wherein the pharmaceutically acceptable carrier is water. 18. The composition of claim 3, wherein the LACA is at a concentration of 54 mg/mL, the composition comprises an acetate buffer, and the pharmaceutically acceptable carrier is water. 19. The composition of claim 18, wherein the acetate buffer comprises acetic acid and sodium acetate. 20. The composition of claim 19 consisting essentially of the LACA, sorbitol, the acetate buffer, and water.