US2017224788A1PendingUtilityA1

C1-inh compositions and methods for the prevention and treatment of disorders associated with c1 esterase inhibitor deficiency

69
Assignee: SHIRE VIROPHARMA INCPriority: Mar 15, 2013Filed: Jan 20, 2017Published: Aug 10, 2017
Est. expiryMar 15, 2033(~6.7 yrs left)· nominal 20-yr term from priority
Inventors:Stephen B. RuddyMark ManningRyan Erik Holcomb
A61K 47/12A61K 47/18A61K 47/183A61K 47/34A61K 38/1709A61K 47/02A61K 9/0019A61K 38/57A61P 31/00A61K 9/08A61K 47/22A61K 38/00C07K 14/81A61K 35/16A61K 9/0021A61K 38/55
69
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Claims

Abstract

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

Claims

exact text as granted — not AI-modified
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.

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