Dosing regimens

Patent metadata

Field	Value
Publication number	US-11903994-B2
Application number	US-201615766795-A
Country	US
Kind code	B2
Filing date	Oct 7, 2016
Priority date	Oct 7, 2015
Publication date	Feb 20, 2024
Grant date	Feb 20, 2024

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.

First claim

We claim:

1. A method of treating a subject in need of treatment for a complement-mediated eye disorder, the method comprising intravitreally administering about 15 mg of a long-acting compstatin analog (LACA) monthly or every other month to the eye of the subject, wherein
(a) the LACA comprises a PEG having an average molecular weight of 40 kD attached to two compstatin analog moieties, wherein
each compstatin analog moiety comprises a cyclic peptide having the amino acid sequence as set forth in SEQ ID NO: 28 extended by a lysine residue at the C-terminus, wherein the lysine residue is separated from the cyclic portion of the peptide by an 8-amino-3,6-dioxaoctanoic acid (AEEAc) spacer;
wherein each end of the PEG is linked to the amino group of the side chain of the lysine residue of one of the compstatin analog moieties by way of a carbamate; and

(b) the complement-mediated eye disorder is geographic atrophy.

2. The method of claim 1 , wherein the LACA is administered intravitreally monthly.

3. The method of claim 1 , wherein the LACA is administered intravitreally every other month.

4. The method of claim 1 , wherein the LACA is administered using a 25, 26, 27, 28, or 29 gauge needle.

5. The method of claim 4 , wherein the needle is a thin-walled needle.

6. The method of claim 1 , wherein the LACA comprises the compound

7. The method of claim 1 , comprising administering the LACA to the subject in the form of a composition comprising the LACA at a concentration of from about 100 to about 200 mg/mL.

8. The method of claim 7 , comprising administering the LACA to the subject in the form of a composition comprising the LACA at a concentration of about 150 mg/mL.

9. The method of claim 1 comprising administering the LACA to the eye of the subject in a volume of from about 90 to about 150 μL.

10. The method of claim 9 , comprising administering the LACA to the eye of the subject in a volume of about 100 μL.

Assignees

• Apellis Pharmaceuticals Inc

Inventors

• Grossi Federico
• Deschatelets Pascal
• Francois Cedric

Classifications

• A61P27/02

  Ophthalmic agents · CPC title

• C07K7/08 Primary

  having 12 to 20 amino acids (gastrins C07K14/595; somatostatins C07K14/655; melanotropins C07K14/68) · CPC title

• A61K38/12 Primary

  Cyclic peptides {, e.g. bacitracins; Polymyxins; Gramicidins S, C; Tyrocidins A, B or C (A61K38/043 - A61K38/046 take precedence)} · CPC title

• A61K9/0019

  Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00) · CPC title

• A61K9/0048

  Eye, e.g. artificial tears · CPC title