US2020277351A1PendingUtilityA1

Peptide pharmaceuticals for insulin resistance

Assignee: MEDERIS DIABETES LLCPriority: May 28, 2014Filed: Jan 21, 2020Published: Sep 3, 2020
Est. expiryMay 28, 2034(~7.9 yrs left)· nominal 20-yr term from priority
Inventors:John J. Nestor
A61P 9/00Y02P20/55C07K 19/00C07H 13/12C07H 13/06A61K 47/549A61P 9/10C07K 14/605A61P 3/08A61K 47/64A61P 3/10A61P 9/12A61K 38/00A61P 31/10A61K 38/26A61P 3/04
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Claims

Abstract

Described herein are methods of syntheses and therapeutic uses of covalently modified peptides and/or proteins. The covalently modified peptides and/or proteins allow for improved pharmaceutical properties of peptide and protein-based therapeutics.

Claims

exact text as granted — not AI-modified
1 . A peptide product comprising a surfactant X, covalently attached to a peptide, the peptide comprising a linker amino acid U and at least one other amino acid: 
       
         
           
           
               
               
           
         
       
       wherein the surfactant X is a group of Formula I: 
       
         
           
           
               
               
           
         
         wherein:
 R 1a  is independently, at each occurrence, a bond, H, a protecting group, a saccharide, a substituted or unsubstituted C 1 -C 30  alkyl group, a substituted or unsubstituted alkoxyaryl group, a substituted or unsubstituted aralkyl group, or a steroid nucleus containing moiety; 
 R 1b , R 1c , and R 1d  are each, independently at each occurrence, a protecting group, a saccharide, a bond, H, a substituted or unsubstituted C 1 -C 30  alkyl group, a substituted or unsubstituted alkoxyaryl group, or a substituted or unsubstituted aralkyl group; 
 W 1  is independently, at each occurrence, —CH 2 —, —CH 2 —O—, —(C═O), —(C═O)—O—, —(C═O)—NH—, —(C═S)—, —(C═S)—NH—, or —CH 2 —S—; 
 W 2  is —O—, —CH 2 — or —S—; 
 R 2  is independently, at each occurrence, a bond to U, H, a substituted or unsubstituted C1-C30 alkyl group, a substituted or unsubstituted alkoxyaryl group, or a substituted or unsubstituted aralkyl group, —NH—, —S—, -triazolo-, —NH(C═O)—CH 2 —, —(CH 2 ) m -maleimide-; 
 n is 1, 2 or 3; and 
 m is an integer of 1-10; 
 
         the peptide is selected from Formula II: 
       
       
         
           
                 
                 
               
                     
                   (SEQ. ID. NO. 1) 
                 
                     
                   aa 1 -aa 2 -aa 3 -aa 4 -aa 5 -aa 6 -aa 7 -aa 8 -aa 9 -aa 10 -aa 11 - 
                 
                     
                     
                 
                     
                   aa 12 -aa 13 -aa 14 -aa 15 -aa 16 -aa 17 -aa 18 -aa 19 -aa 20 - 
                 
                     
                     
                 
                     
                   aa 21 -aa 22 -aa 23 -aa 24 -aa 25 -aa 26 -aa 27 -aa 28 -aa 29 - 
                 
                     
                     
                 
                     
                   aa 30 -aa 31 -aa 32 -aa 33 -aa 34 -aa 35 -aa 36 -aa 37 -Z 
                 
                     
                   Formula II 
                 
             
                
                
                
                
                
                
                
                
                
               
            
           
         
         wherein:
 Z is OH, N—R 4 -His, or —NH—R 3 ,
 wherein 
 R 3  is H, substituted or unsubstituted C 1 -C 12  alkyl, or a PEG chain of less than 10 Da; 
 R 4  is a C 2 -C 10  acyl group, for example Ac or Bz; 
 
 aa 1  is His, N—R 4 -His, pGlu-His, or N—R 3 -His; 
 aa 2  is Ser, D-Ser, Ala, Gly, Pro, MePro, Aib, Ac4c, or Ac5c; 
 aa 3  is Gln or Cit; 
 aa 4  is Gly or D-Ala; 
 aa 5  is Thr or Ser; 
 aa 6  is Phe, Trp, 2FPhe, MePhe, 2FMePhe, or Nal2; 
 aa 7  is Thr or Ser; 
 aa 8  is Ser or Asp; 
 aa 9  is Asp or Glu; 
 aa 10  is Tyr, Leu, Met, Nal2, Bip, Bip2EtMeO, or U; 
 aa 11  is absent or Ser, Asn, Bip, or U; 
 aa 12  is absent or Lys, Glu, Ser, Arg, or U; 
 aa 13  is absent or Tyr, Gln, Cit, or U; 
 aa 14  is absent or Leu, Met, Nle, or U; 
 aa 15  is absent or Asp, Glu, or U; 
 aa 16  is absent or Ser, Gly, Glu, Ala, Aib, Ac5c, Lys, Arg, or U; 
 aa 17  is absent or Arg, hArg, Gln, Glu, Cit, Aib, Ac4c, Ac5c, Lys, or U; 
 aa 18  is absent or Arg, hArg, Ala, Aib, Ac4c, Ac5c, or U; 
 aa 19  is absent or Ala, Val, Aib, Ac4c, Ac5c, or U; 
 aa 20  is absent or Gln, Lys, Arg, Cit, Glu, Aib, Ac4c, Ac5c, or U; 
 aa 21  is absent or Asp, Glu, Leu, Aib, Ac4c, Ac5c, or U; 
 aa 22  is absent or Phe, Trp, Nal2, Aib, Ac4c, Ac5c, or U; 
 aa 23  is absent or Val, Ile, Aib, Ac4c, Ac5c, or U; 
 aa 24  is absent or Ala, Gln, Glu, Cit, or U; 
 aa 25  is absent or Trp, Nal2, or U; 
 aa 26  is Leu; 
 aa 27  is Leu; 
 aa 28  is Gln; 
 aa 29  is Thr; 
 aa 30  is absent or Lys, Aib, Ac4c, Ac5c, Arg, or U; 
 aa 31  is absent or Arg, Aib, Ac4c, Ac5c, or U; 
 aa 32  is absent or Asn, Aib, Ac4c, Ac5c, or U; 
 aa 33  is absent or Arg, Aib, Ac4c, Ac5c, or U; 
 aa 34  is absent or Asn, Aib, Ac4c, Ac5c, or U; 
 aa 35  is absent or Asn, Aib, Ac4c, Ac5c, or U; 
 aa 36  is absent or Ile, Aib, Ac4c, Ac5C, or U; 
 aa 36  is absent or Ala, Aib, Ac4c, Ac5C, or U; 
 aa 37  is absent or U; 
 U is a natural or unnatural amino acid comprising a functional group used for covalent attachment to the surfactant X; 
 
         wherein any two of aa 1 -aa 37  are optionally cyclized through their side chains to form a lactam linkage; and 
         provided that one, or at least one of aa 10 -aa 25  or aa 30 -aa 37  is the linker amino acid U covalently attached to X. 
       
     
     
         2 . The peptide product of  claim 1 , wherein n is 1 or 2. 
     
     
         3 . A peptide product of  claim 1 , wherein X has the structure: 
       
         
           
           
               
               
           
         
         wherein:
 R 1a  is H, a protecting group, a saccharide, a substituted or unsubstituted C 1 -C 30  alkyl group, or a steroid nucleus containing moiety; 
 R 1b , R 1c , and R 1d  are each, independently at each occurrence, H, a protecting group, a saccharide, or a substituted or unsubstituted C 1 -C 30  alkyl group; 
 W 1  is independently, at each occurrence, —CH 2 —, —CH 2 —O—, —(C═O), —(C═O)—O—, —(C═O)—NH—, —(C═S)—, —(C═S)—NH—, or —CH 2 —S—; 
 W 2  is —O—, —S—; 
 R 2  is a bond, —NH—, —S—, —NH(C═O)—CH 2 — or —(CH 2 ) m -maleimide-; and 
 m is an integer of 1-10. 
 
       
     
     
         4 . The peptide product of  claim 3 , wherein X has the structure: 
       
         
           
           
               
               
           
         
       
     
     
         5 . The peptide product of  claim 3 , wherein X has the structure: 
       
         
           
           
               
               
           
         
       
     
     
         6 . The peptide product of  claim 3 , wherein X has the structure: 
       
         
           
           
               
               
           
         
         wherein:
 R 1a  is H, a protecting group, a saccharide, a substituted or unsubstituted C 1 -C 30  alkyl group, or a steroid nucleus containing moiety; 
 R 1b , R 1c , and R 1d  are each, independently at each occurrence, H, a protecting group, or a substituted or unsubstituted C1-C30 alkyl group; 
 W 1  is —(C═O)—NH—; 
 W 2  is —O—; and 
 R 2  is a bond. 
 
       
     
     
         7 . The peptide product of  claim 3 , wherein X has the structure: 
       
         
           
           
               
               
           
         
         wherein:
 R 1a  is a substituted or unsubstituted C 1 -C 30  alkyl group; 
 R 1b , R 1c , and R 1d  are H; 
 W 1  is —(C═O)—NH—; 
 W 2  is —O—; and 
 R 2  is a bond. 
 
       
     
     
         8 . The peptide product of  claim 1 , wherein R 1a  is a substituted or unsubstituted C 1 -C 30  alkyl group. 
     
     
         9 . The peptide product of  claim 1 , wherein R 1a  is a substituted or unsubstituted C 6 -C 20  alkyl group. 
     
     
         10 . The peptide product of  claim 1 , wherein R 1a  is a substituted or unsubstituted C 12 -C 20  alkyl group. 
     
     
         11 . The peptide product of  claim 1 , wherein the surfactant X is a 1-alkyl glycoside class surfactant. 
     
     
         12 . The peptide product of  claim 1 , wherein X comprises 1-eicosyl beta-D-glucuronic acid, 1-octadecyl beta-D-glucuronic acid, 1-hexadecyl beta-D-glucuronic acid, 1-tetradecyl beta-D-glucuronic acid, 1-dodecyl beta-D-glucuronic acid, 1-decyl beta-D-glucuronic acid, 1-octyl beta-D-glucuronic acid, 1-eicosyl beta-D-diglucuronic acid, 1-octadecyl beta-D-diglucuronic acid, 1-hexadecyl beta-D-diglucuronic acid, 1-tetradecyl beta-D-diglucuronic acid, 1-dodecyl beta-D-diglucuronic acid, 1-decyl beta-D-diglucuronic acid, 1-octyl beta-D-diglucuronic acid, or functionalized 1-eicosyl beta-D-glucose, 1-octadecyl beta-D-glucose, 1-hexadecyl beta-D-glucose, 1-tetradecyl beta-D-glucose, 1-dodecyl beta-D-glucose, 1-decyl beta-D-glucose, 1-octyl beta-D-glucose, 1-eicosyl beta-D-maltoside, 1-octadecyl beta-D-maltoside, 1-hexadecyl beta-D-maltoside, 1-tetradecyl beta-D-maltoside, 1-dodecyl beta-D-maltoside, 1-decyl beta-D-maltoside, or 1-octyl beta-D-maltoside, 1-eicosyl beta-D-melibioside, 1-octadecyl beta-D-melibioside, 1-hexadecyl beta-D-melibioside, 1-tetradecyl beta-D-melibioside, 1-dodecyl beta-D-melibioside, 1-decyl beta-D-melibioside, or 1-octyl beta-D-melibioside and the corresponding 6 or 6,6′-dicarboxylates. 
     
     
         13 . The peptide product of  claim 1 , wherein U is selected from Lys, Cys, Orn, Glu, or an unnatural amino acid comprising a functional group used for covalent attachment to the surfactant X. 
     
     
         14 . The peptide product of  claim 1 , having the structure of Formula III-A 
       
         
           
                 
                 
               
                     
                   (SEQ. ID. NO. 2) 
                 
                     
                   aa 1 -aa 2 -aa 3 -aa 4 -aa 5 -aa 6 -aa 7 -aa 8 -aa 9 -aa 10 -aa 11 - 
                 
                     
                     
                 
                     
                   aa 12 -aa 13 -aa 14 -aa 15 -aa 16 -aa 17 -aa 18 -aa 19 -aa 20 - 
                 
                     
                     
                 
                     
                   aa 21 -aa 22 -aa 23 -aa 24 -aa 25 -aa 26 -aa 27 -aa 28 -aa 29 -Z 
                 
                     
                   Formula III-A 
                 
             
                
                
                
                
                
                
                
               
            
           
         
         wherein: 
         Z is OH, or —NH—R 3 ,
 wherein R 3  is H, substituted or unsubstituted C 1 -C 12  alkyl, or a PEG chain of less than 10 Da; 
 
         aa 1  is His, N—Ac-His, pGlu-His, or N—R 3 -His; 
         aa 2  is Ser, Ala, Gly, MePro, Aib, Ac4c, or Ac5c; 
         aa 3  is Gln or Cit; 
         aa 4  is Gly or D-Ala; 
         aa 5  is Thr or Ser; 
         aa 6  is Phe, Trp, 2FPhe, MePhe, 2FMePhe, or Nal2; 
         aa 7  is Thr or Ser; 
         aa 8  is Ser or Asp; 
         aa 9  is Asp or Glu; 
         aa 10  is Tyr, Leu, Met, Nal2, Bip, Bip2EtMeO, or U(X); 
         aa 11  is absent or Ser, Asn, Bip, or U(X); 
         aa 12  is absent or Lys, Glu, Ser, Arg, or U(X); 
         aa 13  is absent or Tyr, Gln, Cit, or U(X); 
         aa 14  is absent or Leu, Met, Nle, or U(X); 
         aa 15  is absent or Asp, Glu, or U(X); 
         aa 16  is absent or Ser, Gly, Glu, Ala, Aib, Ac5c, Lys, Arg, or U(X); 
         aa 17  is absent or Arg, hArg, Gln, Glu, Lys, Cit, Aib, Ac4c, Ac5c, or U(X); 
         aa 18  is absent or Arg, hArg, Ala, Aib, Ac4c, Ac5c, or U(X); 
         aa 19  is absent or Ala, Val, Aib, Ac4c, Ac5c, or U(X); 
         aa 20  is absent or Gln, Lys, Arg, Cit, Glu, Aib, Ac4c, Ac5c, or U(X); 
         aa 2l  is absent or Asp, Glu, Leu, Aib, Ac4c, Ac5c, or U(X); 
         aa 22  is absent or Phe, Trp, Nal2, Aib, Ac4c, Ac5c, or U(X); 
         aa 23  is absent or Val, Ile, Aib, Ac4c, Ac5c, or U(X); 
         aa 24  is absent or Ala, Gln, Glu, Cit, or U(X); 
         aa 25  is absent or Trp, Nal2, or U(X); 
         aa 26  is Leu; 
         aa 27  is Leu; 
         aa 28  is Gln; 
         aa 29  is Thr; 
         wherein any two of aa 1 -aa 29  are optionally cyclized through their side chains to form a lactam linkage; and 
         provided that one, or at least one of aa 10 , aa 11 , aa 12 , aa 16 , aa 17 , aa 18 , aa 19 , aa 20 , aa 21 , aa 22 , aa 23 , aa 24 , or aa 25 , is the natural or unnatural amino acid U covalently attached to X. 
       
     
     
         15 . The peptide product of  claim 1 , having the structure of Formula III-B: 
       
         
           
                 
                 
               
                     
                   (SEQ. ID. NO. 3) 
                 
                     
                   His 1 -aa 2 -aa 3 -Gly 4 -Thr 5 -aa 6 -Thr 7 -Ser 8 -Asp 9 -aa 10 - 
                 
                     
                     
                 
                     
                   aa 11 -aa 12 -aa 13 -aa 14 -aa 15 -aa 16 -aa 17 -aa 18 -aa 19 - 
                 
                     
                     
                 
                     
                   aa 20 -aa 21 -aa 22 -aa 23 -aa 24 -aa 25 -aa 26 -aa 27 -aa 28 - 
                 
                     
                     
                 
                     
                   aa 29 -aa 30 -Z 
                 
                     
                   Formula III-B 
                 
             
                
                
                
                
                
                
                
                
                
               
            
           
         
       
       wherein:
 Z is OH, or —NH—R 3 ,
 wherein R 3  is H, substituted or unsubstituted C 1 -C 12  alkyl, or a PEG chain of less than 10 Da; 
 aa 2  is Gly, MePro or Aib; 
 aa 3  is Gln or Cit; 
 aa 6  is Phe, 2FPhe, MePhe, 2FMePhe, or Nal2; 
 aa 10  is Tyr, Nal2, Bip, Bip2EtMeO, or U(X); 
 aa 11  is absent or Ser, Asn, Bip, or U(X); 
 aa 12  is absent or Lys, Glu, Ser, or U(X); 
 aa 13  is absent or Tyr, Gln, Cit, or U(X); 
 aa 14  is absent or Leu, Nle, or U(X); 
 aa 15  is absent or Asp, Glu, or U(X); 
 aa 16  is absent or Ser, Gly, Glu, Ala, Aib, Lys, Arg, or U(X); 
 aa 17  is absent or Arg, hArg, Gln, Glu, Lys, Cit, Aib, or U(X); 
 aa 18  is absent or Arg, hArg, Ala, Aib, Ac4c, Ac5c, or U(X); 
 aa 19  is absent or Ala, Aib, or U(X); 
 aa 20  is absent or Gln, Lys, Arg, Cit, Glu, Aib, or U(X); 
 aa 21  is absent or Asp, Glu, Leu, Aib, or U(X); 
 aa 22  is absent or Phe, or U(X) 
 aa 23  is absent or Val, Ile, Aib or U(X); 
 aa 24  is absent or Ala, Gln or U(X); 
 aa 25  is absent or Trp or U(X); 
 aa 26  is Leu; 
 aa 27  is Leu; 
 aa 28  is Gln; 
 aa 29  is Thr; 
 aa 30  is absent or Arg or U(X); 
 
 wherein any two of aa 1 -aa 23  are optionally cyclized through their side chains to form a lactam linkage; and 
 provided that one, or at least one of aa 10 , aa 11 , aa 12 , aa 16 , aa 17 , aa 18 , aa 19 , aa 20 , aa 21 , aa 22 , aa 23 , or aa 24 , is the natural or unnatural amino acid U covalently attached to X. 
 
     
     
         16 . The peptide product of  claim 1 , wherein aa 17  is a lysine residue attached to X. 
     
     
         17 - 33 . (canceled) 
     
     
         34 . A pharmaceutical composition comprising a therapeutically effective amount of a peptide product of  claim 1 , or acceptable salt thereof, and at least one pharmaceutically acceptable carrier or excipient. 
     
     
         35 . A method of treating a condition associated with insulin resistance comprising administration of a peptide product of  claim 1  to an individual in need thereof. 
     
     
         36 - 40 . (canceled) 
     
     
         41 . The method of  claim 35 , wherein the administration of said glucagon analog causes weight loss. 
     
     
         42 - 78 . (canceled) 
     
     
         79 . The peptide product of  claim 1 , having the structure of Formula III-A 
       
         
           
                 
                 
               
                     
                   (SEQ. ID. NO. 1110) 
                 
                     
                   aa 1 -aa 2 -aa 3 -aa 4 -aa 5 -aa 6 -aa 7 -aa 8 -aa 9 -aa 10 -aa 11 - 
                 
                     
                     
                 
                     
                   aa 12 -aa 13 -aa 14 -aa 15 -aa 16 -aa 17 -aa 18 -aa 19 -aa 20 - 
                 
                     
                     
                 
                     
                   aa 21 -aa 22 -aa 23 -aa 24 -aa 25 -aa 26 -aa 27 -aa 28 -aa 29 -Z 
                 
                     
                   Formula III-A 
                 
             
                
                
                
                
                
                
                
               
            
           
         
         wherein: 
         Z is OH, or —NH—R 3 , wherein R 3  is H, or C 1 -C 12  substituted or unsubstituted alkyl, or a PEG chain of less than 10 Da; 
         aa 1  is His; 
         aa 2  is Aib; 
         aa 3  is Gln; 
         aa 4  is Gly; 
         aa 5  is Thr; 
         aa 6  is Phe; 
         aa 7  is Thr; 
         aa 8  is Ser; 
         aa 9  is Asp; 
         aa 10  is Tyr, Glu, Lys, or U(X); 
         aa 11  is Ser; 
         aa 12  is Lys or Glu; 
         aa 13  is Tyr; 
         aa 14  is Leu, Glu, or Lys; 
         aa 15  is Asp; 
         aa 16  is Glu or Lys; 
         aa 17  is Gln, Glu, or U(X); 
         aa 18  is Ala; 
         aa 19  is Ala; 
         aa 20  is Lys, Glu or U(X); 
         aa 21  is Glu; 
         aa 22  Phe; 
         aa 23  is Ile; 
         aa 24  is Gln, Glu, or U(X); 
         aa 25  is Trp; 
         aa 26  is Leu; 
         aa 27  is Leu; 
         aa 28  is Gln; 
         aa 29  is Thr; 
         wherein aa 16  and aa 20 , or aa 10  and aa 14 , or aa 12  and aa 16  are optionally cyclized through their side chains to form a lactam linkage; and
 provided that one, or at least one of aa 10 , aa 17 , aa 20 , or aa 24  is the natural or unnatural amino acid U covalently attached to X.

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