Granted Patent
B2
US 12,290,566 · App. 18/115,744 · Granted May 6, 2025
Dosing regimens and related compositions and methods
Inventors:
Federico Grossi (Needham, MA); Pascal Deschatelets (West Newton, MA); Cedric Francois (Prospect, KY); Patrick Johnson (Zurich, CH); Carolina Vega (Berkeley, CA)
Assignee:
Apellis Pharmaceuticals, Inc.
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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.
Claims (25)
1. A composition comprising:
(i) a long-acting compstatin analog (LACA) having a structure:
wherein the (CH 2 CH 2 O) 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.
Assignments (5)
RELEASE OF PATENT SECURITY AGREEMENT RECORDED AT REEL 067398 AND FRAME 0261
Recorded May 15, 2026
From: SIXTH STREET LENDING PARTNERS, IN ITS CAPACITY AS ADMINISTRATIVE AGENT
To: APELLIS PHARMACEUTICALS, INC.
Reel/Frame 075652/0212 →
SECURITY INTEREST
Recorded May 13, 2024
From: APELLIS PHARMACEUTICALS, INC.
To: SIXTH STREET LENDING PARTNERS
Reel/Frame 067398/0261 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Nov 10, 2023
From: GROSSI, FEDERICO; DESCHATELETS, PASCAL; FRANCOIS, CEDRIC; VEGA, CAROLINA
To: APELLIS PHARMACEUTICALS, INC.
Reel/Frame 065526/0282 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Nov 10, 2023
From: JOHNSON, PATRICK
To: JPHARMA SOLUTIONS GMBH
Reel/Frame 065526/0323 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Nov 10, 2023
From: JPHARMA SOLUTIONS GMBH
To: APELLIS PHARMACEUTICALS, INC.
Reel/Frame 065526/0340 →
Continuity (5)
Continuation
16772729
Provisional Application
62744565
· Oct 11, 2018
Provisional Application
62655094
· Apr 9, 2018
Provisional Application
62599637
· Dec 15, 2017
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