US2021121571A1PendingUtilityA1

Methods of reducing aggregation of il-1ra

61
Assignee: SWEDISH ORPHAN BIOVITRUM AB PUBLPriority: Apr 2, 2004Filed: Jul 31, 2020Published: Apr 29, 2021
Est. expiryApr 2, 2024(expired)· nominal 20-yr term from priority
Inventors:Andrei A. RaibekasBruce Kerwin
A61K 9/0019C07K 14/545C07K 14/54A61P 35/02A61P 19/02A61K 47/26A61P 13/12A61P 29/00A61K 47/02A61P 1/04A61K 33/42A61K 38/20Y02A50/30A61K 47/12A61P 1/00A61K 31/7012
61
PatentIndex Score
0
Cited by
0
References
0
Claims

Abstract

Methods of reducing aggregation of an aggregating IL-1ra comprising incubating IL-1ra with at least one accessory molecule are provided. Kits comprising IL-1ra and at least one accessory molecule are also provided. Pharmaceutical compositions comprising IL-1ra and at least one accessory molecule are also provided.

Claims

exact text as granted — not AI-modified
1 - 9 . (canceled) 
     
     
         10 . A method of preparing an interleukin-1 receptor antagonist (IL-1ra) drug formulation comprising incubating an aggregating IL-1ra with at least one accessory molecule at a concentration sufficient to reduce aggregation of the IL-1ra or reduce the rate of aggregation of the IL-1ra, wherein at least one of the at least one accessory molecule is selected from a sugar and a multiple-charge anion, wherein aggregation is reduced. 
     
     
         11 . The method of  claim 10 , wherein at least one accessory molecule is a multiple-charge anion. 
     
     
         12 . The method of  claim 11 , wherein said multiple-charge anion is 1 to 20 mM pyrophosphate. 
     
     
         13 . The method of  claim 11 , wherein said multiple-charge anion is 1 to 20 mM citrate. 
     
     
         14 . The method of  claim 10 , wherein at least one accessory molecule is a sugar. 
     
     
         15 . The method of  claim 14 , wherein said sugar is glycerol, sorbitol, or sucrose. 
     
     
         16 . The method of  claim 14 , wherein said sugar is at a concentration of from 1 to 3 percent. 
     
     
         17 . The method of  claim 10 , wherein at least one accessory molecule is selected from a lysine-reactive accessory molecule and an arginine-reactive accessory molecule. 
     
     
         18 . The method of  claim 10 , wherein at least one accessory molecule is selected from 6-(N-(7-nitrobenz-2-oxa-1,3-diazol-4-yl)amino)hexanoic acid (NBD-X), methyl acetyl phosphate (MAP), and citraconic anhydride. 
     
     
         19 . A method of treating a patient comprising administering to the patient a composition comprising (i) a therapeutically effective amount of an aggregating interleukin-1 receptor antagonist (IL-1ra) and (ii) at least one accessory molecule at a concentration sufficient to reduce aggregation of the IL-1ra or reduce the rate of aggregation of the IL-1ra, wherein at least one of the at least one accessory molecule is selected from a sugar and a multiple-charge anion. 
     
     
         20 . The method of  claim 19 , wherein at least one accessory molecule is a multiple-charge anion. 
     
     
         21 . The method of  claim 20 , wherein said multiple-charge anion is 1 to 20 mM pyrophosphate. 
     
     
         22 . The method of  claim 20 , wherein said multiple-charge anion is 1 to 20 mM citrate. 
     
     
         23 . The method of  claim 19 , wherein at least one accessory molecule is a sugar. 
     
     
         24 . The method of  claim 23 , wherein said sugar is glycerol, sorbitol, or sucrose. 
     
     
         25 . The method of  claim 23 , wherein said sugar is at a concentration of from 1 to 3 percent. 
     
     
         26 . The method of  claim 19 , wherein at least one accessory molecule is selected from a lysine-reactive accessory molecule and an arginine-reactive accessory molecule. 
     
     
         27 . The method of  claim 19 , wherein at least one accessory molecule is selected from 6-(N-(7-nitrobenz-2-oxa-1,3-diazol-4-yl)amino)hexanoic acid (NBD-X), methyl acetyl phosphate (MAP), and citraconic anhydride. 
     
     
         28 . A method of treating a patient having rheumatoid arthritis comprising administering to the patient a composition comprising (i) a therapeutically effective amount of an aggregating interleukin-1 receptor antagonist (IL-1ra) and (ii) at least one accessory molecule at a concentration sufficient to reduce aggregation of the IL-1ra or reduce the rate of aggregation of the IL-1ra, wherein at least one of the at least one accessory molecule is selected from a sugar and a multiple-charge anion. 
     
     
         29 . The method of  claim 28 , wherein at least one accessory molecule is a multiple-charge anion. 
     
     
         30 . The method of  claim 29 , wherein said multiple-charge anion is 1 to 20 mM pyrophosphate. 
     
     
         31 . The method of  claim 29 , wherein said multiple-charge anion is 1 to 20 mM citrate. 
     
     
         32 . The method of  claim 28 , wherein at least one accessory molecule is a sugar. 
     
     
         33 . The method of  claim 32 , wherein said sugar is glycerol, sorbitol, or sucrose. 
     
     
         34 . The method of  claim 32 , wherein said sugar is at a concentration of from 1 to 3 percent. 
     
     
         35 . The method of  claim 28 , wherein at least one accessory molecule is selected from a lysine-reactive accessory molecule and an arginine-reactive accessory molecule. 
     
     
         36 . The method of  claim 28 , wherein at least one accessory molecule is selected from 6-(N-(7-nitrobenz-2-oxa-1,3-diazol-4-yl)amino)hexanoic acid (NBD-X), methyl acetyl phosphate (MAP), and citraconic anhydride. 
     
     
         37 . A method of treating a patient having osteoarthritis comprising administering to the patient a composition comprising (i) a therapeutically effective amount of an aggregating interleukin-1 receptor antagonist (IL-1ra) and (ii) at least one accessory molecule at a concentration sufficient to reduce aggregation of the IL-1ra or reduce the rate of aggregation of the IL-1ra, wherein at least one of the at least one accessory molecule is selected from a sugar and a multiple-charge anion. 
     
     
         38 . The method of  claim 37 , wherein at least one accessory molecule is a multiple-charge anion. 
     
     
         39 . The method of  claim 38 , wherein said multiple-charge anion is 1 to 20 mM pyrophosphate. 
     
     
         40 . The method of  claim 38 , wherein said multiple-charge anion is 1 to 20 mM citrate. 
     
     
         41 . The method of  claim 37 , wherein at least one accessory molecule is a sugar. 
     
     
         42 . The method of  claim 41 , wherein said sugar is glycerol, sorbitol, or sucrose. 
     
     
         43 . The method of  claim 41 , wherein said sugar is at a concentration of from 1 to 3 percent. 
     
     
         44 . The method of  claim 37 , wherein at least one accessory molecule is selected from a lysine-reactive accessory molecule and an arginine-reactive accessory molecule. 
     
     
         45 . The method of  claim 37 , wherein at least one accessory molecule is selected from 6-(N-(7-nitrobenz-2-oxa-1,3-diazol-4-yl)amino)hexanoic acid (NBD-X), methyl acetyl phosphate (MAP), and citraconic anhydride. 
     
     
         46 . A pharmaceutical composition comprising an aggregating interleukin-1 receptor antagonist (IL-1ra) and at least one accessory molecule at a concentration sufficient to reduce aggregation of the IL-1ra or reduce the rate of aggregation of the IL-1ra, wherein at least one of the at least one accessory molecule is selected from a sugar and a multiple-charge anion, and wherein aggregation is reduced. 
     
     
         47 . The pharmaceutical composition of  claim 46 , wherein at least one accessory molecule is a multiple-charge anion. 
     
     
         48 . The pharmaceutical composition of  claim 47 , wherein said multiple-charge anion is 1 to 20 mM pyrophosphate. 
     
     
         49 . The pharmaceutical composition of  claim 47 , wherein said multiple-charge anion is 1 to 20 mM citrate. 
     
     
         50 . The pharmaceutical composition of  claim 46 , wherein at least one accessory molecule is a sugar. 
     
     
         51 . The pharmaceutical composition of  claim 50 , wherein said sugar is glycerol, sorbitol, or sucrose. 
     
     
         52 . The pharmaceutical composition of  claim 50 , wherein said sugar is at a concentration of from 1 to 3 percent. 
     
     
         53 . The pharmaceutical composition of  claim 46 , wherein at least one accessory molecule is selected from a lysine-reactive accessory molecule and an arginine-reactive accessory molecule. 
     
     
         54 . The pharmaceutical composition of  claim 46 , wherein at least one accessory molecule is selected from 6-(N-(7-nitrobenz-2-oxa-1,3-diazol-4-yl)amino)hexanoic acid (NBD-X), methyl acetyl phosphate (MAP), and citraconic anhydride.

Join the waitlist — get patent alerts

Track US2021121571A1 — get alerts on status changes and closely related new filings.

We store only your email — no account needed. See our privacy policy.