IP Library Patent Application 15411744
Patent Application
App. No. 15/411,744

C1-INH COMPOSITIONS AND METHODS FOR THE PREVENTION AND TREATMENT OF DISORDERS ASSOCIATED WITH C1 ESTERASE INHIBITOR DEFICIENCY

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Patent No.
US None
App. No.
15/411,744
Abstract

Compositions and methods for the treatment and/or prevention of disorders associated with C1 esterase inhibitor deficiency are disclosed.

Claims (31)

1 - 15 . (canceled)

16 . A method for treating hereditary angioedema (HAE), said method comprising subcutaneously administering to a subject in need thereof a composition comprising a C1 esterase inhibitor, wherein the C1 esterase inhibitor is administered at a concentration of at least about 400 U/mL and a dose of at least about 1000 U.

17 . The method of claim 16 , wherein the C1 esterase inhibitor is present in the composition in a concentration of at least about 500 U/mL in the composition.

18 . The method of claim 16 , further comprising a buffer selected from citrate or phosphate, and having a pH ranging from 6.5-8.0.

19 . The method of claim 16 , wherein the buffer is citrate.

20 . The method of claim 16 , wherein the buffer is phosphate.

21 . The method of claim 16 , wherein the administration of the composition comprising the C1 esterase inhibitor increases the level of C1 esterase inhibitor in the blood of the subject to at least about 0.4 U/mL.

22 . The method of claim 16 , wherein the composition is administered daily, every other day, or every three days.

23 . The method of claim 16 , wherein the composition is administered one, two, or three times a week.

24 . The method of claim 16 , wherein the C1 esterase inhibitor comprises an amino acid sequence at least about 90% identical to amino acid sequence SEQ ID NO: 1.

25 . The method of claim 24 , wherein the C1 esterase inhibitor comprises an amino acid sequence identical to amino acid residues 23-500 of SEQ ID NO: 1.

26 . The method of claim 16 , wherein the C1 esterase inhibitor is human plasma derived.

27 . The method of claim 16 , wherein the C1 esterase inhibitor is recombinantly produced.

28 . The method of claim 16 , wherein the HAE is Type I HAE or Type II HAE.

29 . The method of claim 16 , wherein the administration of the composition comprising a C1 esterase inhibitor results in HAE prophylactic treatment.

30 . The method of claim 16 , wherein the administration of the composition comprising a C1 esterase inhibitor results in treatment of an HAE attack.

31 . The method of claim 16 , wherein the administration of the composition results in at least a reduction in the severity and/or number of HAE attacks.

32 . The method of claim 16 , wherein the composition is a liquid formulation.

33 . The method of claim 16 , wherein the composition is reconstituted from a lyophilized powder.

34 . The method of claim 16 , wherein the composition has a viscosity of less than about 35 mPa-s.

35 . The method of claim 34 , wherein the viscosity of the composition is about between 7-10 mPa-s.

36 . A composition for treating hereditary angioedema (HAE) by subcutaneous administration comprising a C1 esterase inhibitor, a buffer selected from citrate or phosphate, and having a pH ranging from 6.5-8.0, wherein the C1 esterase inhibitor has a concentration of at least about 400 U/mL, and wherein the C1 esterase inhibitor comprises an amino acid sequence at least 95% identical to residues 23 to 500 of SEQ ID NO: 1.

37 . The composition of claim 36 , wherein the C1 esterase inhibitor is present in the composition in a concentration of at least about 500 U/mL.

38 . The composition of claim 36 , wherein the C1 esterase inhibitor is purified from plasma.

39 . The composition of claim 36 , wherein the C1 esterase inhibitor is recombinantly produced.

40 . The composition of claim 36 , wherein the C1 esterase inhibitor comprises the amino acid sequence of residues 23 to 500 of SEQ ID NO: 1.

41 . The composition of claim 36 , wherein the composition is a liquid formulation.

42 . The composition of claim 36 , wherein the composition is reconstituted from lyophilized powder.

43 . The composition of claim 36 , wherein the buffer is citrate.

44 . the composition of claim 36 , wherein the buffer is phosphate.

45 . The composition of claim 36 , wherein the composition has a viscosity of less than about 35 mPa-s.

Assignments (3)
MERGER Recorded Jul 15, 2021
From: SHIRE VIROPHARMA LLC
To: VIROPHARMA BIOLOGICS LLC
Reel/Frame 056870/0151 →
CHANGE OF NAME Recorded Jan 14, 2020
From: SHIRE VIROPHARMA INCORPORATED
To: SHIRE VIROPHARMA LLC
Reel/Frame 051585/0806 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 26, 2017
From: RUDDY, STEPHEN; MANNING, MARK CORNELL; HOLCOMB, RYAN
To: SHIRE VIROPHARMA INCORPORATED
Reel/Frame 042149/0950 →