Dosing regimens and related compositions and methods

Inventors

Grossi, Federico • Deschatelets, Pascal • Francois, Cedric • Johnson, Patrick • Vega, Carolina

Assignees

Jpharma Solutions GmbH • Apellis Pharmaceuticals Inc

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.

Core Innovation

The invention relates to complement inhibition using compstatin analogs and to a pharmaceutical composition comprising a long-acting compstatin analog (LACA) having a structure in which the (CH2CH2O)n moiety has an average molecular weight of about 40,000 Daltons. The composition further comprises a pharmaceutically acceptable carrier and sorbitol.

The composition is defined to have a pH of 5.0. Dependent refinements described in the provided material include sorbitol within about 2.5% w/v to about 4.5% w/v, a LACA concentration such as 54 mg/mL, and an acetate buffer made from acetic acid and sodium acetate.

The provided content further includes long-acting and cell-reactive compstatin analog concepts and designs for increasing in vivo lifetime, including PEG/Fc/albumin concepts and covalent tethering concepts. It also refers to contacting an isolated graft with a cell-reactive compstatin analog to covalently attach the analog to graft tissue or cells.

Claims Coverage

The provided material identifies one independent claim directed to a pharmaceutical composition defined by a long-acting compstatin analog, a pharmaceutically acceptable carrier, sorbitol, and a pH of 5.0.

The claim coverage centers on a pharmaceutical composition defined by a long-acting compstatin analog with an (CH2CH2O)n moiety averaging about 40,000 Daltons, inclusion of a pharmaceutically acceptable carrier and sorbitol, and a composition pH of 5.0.

Stated Advantages

Documented Applications