DOSING REGIMENS AND RELATED COMPOSITIONS AND METHODS
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.
1 .- 361 . (canceled)
362 . 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 4.9 to 5.1.
363 . The composition of claim 362 , wherein the composition comprises sorbitol at between about 2.5% w/v and about 4.5% w/v.
364 . The composition of claim 362 , wherein the composition comprises sorbitol at between about 4.0% w/v and about 4.5% w/v.
365 . The composition of claim 362 , wherein the LACA is at a concentration of 54 mg/mL.
366 . The composition of claim 362 , wherein the composition comprises an acetate buffer.
367 . The composition of claim 366 , wherein the acetate buffer comprises acetic acid and sodium acetate.
368 . The composition of claim 362 , wherein the pharmaceutically acceptable carrier is water.
369 . The composition of claim 363 , wherein the LACA is at a concentration of 54 mg/mL, the composition comprises an acetate buffer, and the pharmaceutically acceptable carrier is water.
370 . A unit dose comprising the composition of claim 369 , wherein the amount of the LACA in the unit dose is between about 990 mg and about 1215 mg.
371 . The unit dose of claim 370 , wherein the amount of the LACA in the unit dose is about 1080 mg.
372 . The composition of claim 364 , wherein the LACA is at a concentration of 54 mg/mL, the composition comprises an acetate buffer, and the pharmaceutically acceptable carrier is water.
373 . The composition of claim 372 , wherein the acetate buffer comprises acetic acid and sodium acetate.
374 . The composition of claim 373 consisting essentially of the LACA, sorbitol, the acetate buffer, and water.
375 . A unit dose comprising the composition of claim 362 , wherein the amount of the LACA in the unit dose is between about 990 mg and about 1215 mg.
376 . The unit dose of claim 375 , wherein the amount of the LACA in the unit dose is about 1080 mg.
377 . 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 4.5 to 5.0.
378 . The composition of claim 377 , wherein the composition comprises sorbitol at between about 2.5% w/v and about 4.5% w/v.
379 . The composition of claim 377 , wherein the composition comprises sorbitol at between about 4.0% w/v and about 4.5% w/v.
380 . The composition of claim 377 , wherein the LACA is at a concentration of 54 mg/mL.
381 . The composition of claim 377 , wherein the composition comprises an acetate buffer.
382 . The composition of claim 381 , wherein the acetate buffer comprises acetic acid and sodium acetate.
383 . The composition of claim 377 , wherein the pharmaceutically acceptable carrier is water.
384 . The composition of claim 378 , wherein the LACA is at a concentration of 54 mg/mL, the composition comprises an acetate buffer, and the pharmaceutically acceptable carrier is water.
385 . A unit dose comprising the composition of claim 384 , wherein the amount of the LACA in the unit dose is about 1080 mg.
386 . The composition of claim 379 , wherein the LACA is at a concentration of 54 mg/mL, the composition comprises an acetate buffer, and the pharmaceutically acceptable carrier is water.
387 . The composition of claim 386 , wherein the acetate buffer comprises acetic acid and sodium acetate.
388 . The composition of claim 387 , consisting essentially of the LACA, sorbitol, the acetate buffer, and water.
389 . The composition of claim 377 , wherein the pH of the composition is 4.5.
390 . A unit dose comprising the composition of claim 377 , wherein the amount of the LACA in the unit dose is between about 990 mg and about 1215 mg.
391 . The unit dose of claim 390 , wherein the amount of the LACA in the unit dose is about 1080 mg.