Claims for Patent: 11,903,994

Summary for Patent: 11,903,994

Title:	Dosing regimens
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
Assignee:	Apellis Pharmaceuticals Inc
Application Number:	US15/766,795
Patent Claims:	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.