Claims for Patent: 8,951,522

Summary for Patent: 8,951,522

Title:	Methods for treating conditions associated with MASP-2 dependent complement activation
Abstract:	In one aspect, the invention provides methods of inhibiting the effects of MASP-2-dependent complement activation in a living subject. The methods comprise the step of administering, to a subject in need thereof, an amount of a MASP-2 inhibitory agent effective to inhibit MASP-2-dependent complement activation. In some embodiments, the MASP-2 inhibitory agent inhibits cellular injury associated with MASP-2-mediated alternative complement pathway activation, while leaving the classical (C1q-dependent) pathway component of the immune system intact. In another aspect, the invention provides compositions for inhibiting the effects of lectin-dependent complement activation, comprising a therapeutically effective amount of a MASP-2 inhibitory agent and a pharmaceutically acceptable carrier.
Inventor(s):	Demopulos; Gregory A. (Seattle, WA), Dudler; Thomas (Bellevue, WA), Schwaeble; Hans-Wilhelm (Mountsorrel, GB)
Assignee:	University of Leicester (Leicester, GB) Omeros Corporation (Seattle, WA)
Application Number:	13/441,827
Patent Claims:	1. A method of inhibiting MASP-2-dependent complement activation in a subject suffering from paroxysmal nocturnal hemoglobinuria (PNH), comprising administering to the subject a composition comprising an amount of a monoclonal MASP-2 inhibitory antibody, or antigen-binding fragment thereof, that specifically binds to a portion of SEQ ID NO:6 and selectively inhibits MASP-2-dependent complement activation without substantially inhibiting the C1q-dependent complement pathway. 2. The method of claim 1, wherein the composition increases the survival of red blood cells in the subject. 3. The method of claim 1, wherein the subject exhibits one or more symptoms selected from the group consisting of (i) below normal levels of hemoglobin, (ii) below normal levels of platelets; (iii) above normal levels of reticulocytes, and (iv) above normal levels of bilirubin. 4. The method of claim 1, wherein the subject has previously undergone, or is currently undergoing, treatment with an anti-C5 antibody or antigen binding fragment thereof that inhibits cleavage of complement protein C5. 5. The method of claim 1, wherein the method further comprises administering to the subject an anti-C5 antibody or antigen binding fragment thereof that inhibits cleavage of complement protein C5. 6. The method of claim 5, wherein the anti-C5 antibody or antigen binding fragment thereof is humanized. 7. The method of claim 6, wherein the anti-C5 antibody is eculizumab. 8. The method of claim 1, wherein the monoclonal antibody or antigen-binding fragment thereof is a recombinant antibody. 9. The method of claim 1, wherein the composition is administered subcutaneously, intra-muscularly, intra-arterially, intravenously, or as an inhalant. 10. The method of claim 1, wherein the composition is administered subcutaneously. 11. The method of claim 1, wherein the monoclonal antibody or antigen-binding fragment thereof is an antibody having reduced effector function. 12. The method of claim 1, wherein the monoclonal antibody or antigen-binding fragment thereof is a chimeric antibody. 13. The method of claim 1, wherein the monoclonal antibody or antigen-binding fragment thereof is a humanized antibody. 14. The method of claim 1, wherein the monoclonal antibody or antigen-binding fragment thereof is a human antibody.

Details for Patent 8,951,522

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Alexion Pharmaceuticals, Inc.	SOLIRIS	eculizumab	Injection	125166	03/16/2007		2031-04-08