US2004192608A1PendingUtilityA1

Treatment of obesity

56
Assignee: METABOLIC PHARM LTDPriority: Sep 8, 1997Filed: May 11, 2004Published: Sep 30, 2004
Est. expirySep 8, 2017(expired)· nominal 20-yr term from priority
A61K 38/00C07K 14/61A61P 3/04A61P 5/06A61P 43/00
56
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Claims

Abstract

A method for the treatment of obesity in an animal such as a human, comprises administering to the animal an effective amount of a peptide which comprises an analogue of the carboxyl-terminal sequence of a growth hormone, particularly an analogue of the carboxyl-terminal sequence of human growth hormone containing amino acid residues 177-191. A pharmaceutical composition for use in the treatment of obesity is also disclosed.

Claims

exact text as granted — not AI-modified
1 . A method for the treatment of obesity in an animal, said method comprising administering to the animal an effective amount of 
 (A) a peptide comprising an analogue of the carboxyl-terminal sequence of a growth hormone, said caxboxyl-terminal sequence containing amino acid residues 177-191 of human growth hormone:                              Leu-Arg-Ile-Val-Gln-Cys-Arg-Ser-Val-   (SEQ ID NO: 1)               Glu-Gly-Ser-Cys-Gly-Phe,                            or a corresponding sequence of a non-human mammalian growth hormone; wherein in said analogue 
 (i) amino acids at positions 182 and 189 of hGH are joined by a bond to promote a cyclic conformation, and/or  
 (ii) amino acids at positions 183 and 186 of hGH are joined by a salt bridge or a covalent bond;  
   (B) or an organic or inorganic acid addition salt thereof.    
     
     
         2 . The method of  claim 1 , wherein said peptide comprises a bond between amino acids at positions 182 and 189 which is a disulfide bond.  
     
     
         3 . The method of  claim 1 , wherein said peptide comprises amino acids at positions 182 and 189 selected from the group consisting of L-Cys, D-Cys, L-Pen and D-Pen.  
     
     
         4 . The method of  claim 1 , wherein said peptide comprises amino acids at positions 183 and 186 which are joined by an amide covalent bond.  
     
     
         5 . The method of  claim 4 , wherein said peptide comprises amino acids at positions 183 and 186 which axe (X and Y) or (Y and X), respectively, where: 
 X is selected from the group consisting of L- or D-Lys or Om and    Y is selected from the group consisting of L- or D- Asp and Glu.    
     
     
         6 . A method for the treatment of obesity in an animal, said method comprising administering to the animal an effective amount of 
 (A) a peptide of the sequence:                              X 1 m-Leu-Arg-Ile-Val-Gln-Cys-Arg-Ser-   (SEQ ID NO: 2)               Val-Glu-Gly-Ser-Cys-Gly-Phe-X 2 n                           wherein X 1  and X 2  are each selected from the group consisting of L- or D- Arg, His, Lys and Tyr, and m and n are each 0, 1, 2, or 3 with the proviso that at least m or n is 1;    (B) or a cyclic disulfide thereof or an organic or inorganic acid addition salt thereof.    
     
     
         7 . A method for the treatment of obesity in an animal, said method comprising administering to the animal an effective amount of 
 (A) a peptide of the sequence:                              Y 1 -Leu-Arg-Ile-Val-Gln-Cys-Arg-Ser-   (SEQ ID NO: 3)               Val-Glu-Gly-Ser-Cys-Gly-Phe                            wherein Y 1  is selected from the group consisting of the desamino form (H), acetyl (CH 3 CO—) and other acyl groups; or    (B) a cyclic disulfide thereof or an organic or inorganic acid addition salt thereof.    
     
     
         8 . A method for the treatment of obesity in an animal, said method comprising administering to the animal an effective amount of 
 (A) a peptide of the sequence:    Leu-Arg-Ile-Val-Gln-Cys-Arg-Ser-Val-Glu-Gly-Ser-Cys-Gly-Phe-Y 2  (SEQ ID NO: 4) wherein Y 2  is selected from the group consisting of CONH 2  and alkyl amide groups; or    (B) a cyclic disulfide thereof or an organic or inorganic acid addition salt thereof.    
     
     
         9 . A method for the treatment of obesity in an animal, said method comprising administering to the animal an effective amount of a peptide selected from the group consisting of:  
       
         
           
                 
                 
               
                     
                 
                     
                 
                   Ref No. 
                   STRUCTURE 
                 
                     
                 
                     
                 
                 
                 
                 
               
                   9502 
                   Leu Arg Ile Val Gln  Pen  Arg Ser Val Glu Gly Ser  Pen  Gly Phe 
                     
                 
                     
                 
                   9405 
                     CH 3 CO - Leu Arg Ile Val Gln Cys Arg Ser Val Glu Gly Ser Cys Gly Phe 
                 
                     
                 
                   9410 
                     H  - Leu Arg Ile Val Gln Cys Arg Ser Val Glu Gly Ser Cys Gly Phe 
                 
                     
                 
                   9404 
                   Leu Arg Ile Val Gln Cys Arg Ser Val Glu Gly Ser Cys Gly Phe -  CONH 2     
                 
                     
                 
                   9407 
                   Leu Arg Ile Val Gln Cys  Lys  Ser Val Gln Gly Ser Cys Gly Phe 
                 
                     
                 
                   9408 
                   Leu Arg Ile Val Gln Cys  Lys  Ser Val Glu Gly Ser Cys Gly Phe 
                 
                     
                                           |              |(amide bond) 
                 
                     
                 
                   9604 
                     Tyr  Leu Arg Ile Val Gln Cys Arg Ser Val Glu Gly Ser Cys Gly Phe 
                 
                     
                 
                   9605 
                     Lys  Leu Arg Ile Val Gln Cys Arg Ser Val Glu Gly Ser Cys Gly Phe 
                 
                     
                 
                   9618 
                     Lys   Lys  Leu Arg Ile Val Gln Cys Arg Ser Val Glu Gly Ser Cys Gly Phe 
                 
                     
                 
                   9607 
                     Ala  Arg Ile Val Gln Cys Arg Ser Val Glu Gly Ser Cys Gly Phe 
                 
                     
                 
                   9606 
                   Leu  Lys  Ile Val Gln Cys Arg Ser Val Glu Gly Ser Cys Gly Phe 
                 
                     
                 
                   9608 
                   Leu Arg  Ala  Val Gln Cys Arg Ser Val Gln Gly Ser Cys Gly Phe 
                 
                     
                 
                   9403 
                   Leu Arg  Lys  Val Gln Cys Arg Ser Val Glu Gly Ser Cys Gly Phe 
                 
                     
                 
                   9609 
                   Leu Arg Ile  Ala  Gln Cys Arg Ser Val Glu Gly Ser Cys Gly Phe 
                 
                     
                 
                   9610 
                   Leu Arg Ile Val  Ala  Cys Arg Ser Val Glu Gly Ser Cys Gly Phe 
                 
                     
                 
                   9612 
                   Leu Arg Ile Val Gln Cys Arg  Ala  Val Glu Gly Ser Cys Gly Phe 
                 
                     
                 
                   9613 
                   Leu Arg Ile Val Gln Cys Arg Ser  Ala  Glu Gly Ser Cys Gly Phe 
                 
                     
                 
                   9615 
                   Leu Arg Ile Val Gln Cys Arg Ser Val Glu  Ala  Ser Cys Gly Phe 
                 
                     
                 
                   9616 
                   Leu Arg Ile Val Gln Cys Arg Ser Val Glu Gly  Ala  Cys Gly Phe 
                 
                     
                 
                   9602 
                   Leu Arg Ile Val Gln Cys Arg Ser Val Flu Gly Ser Cys  Ala  Phe 
                 
                     
                 
                   9501 
                   Leu Arg Ile Val Gln Cys Arg Ser Val Glu  D-Ala  Ser Cys  D-Ala  Phe 
                 
                     
                 
                   9601 
                   Leu Arg Ile Val Gln Cys Arg Ser Val Glu Gly Ser Cys Gly  Ala   
                 
                     
                 
                     
                 
             
                
                
                
                
               
               
                
               
            
             
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
               
            
           
         
         wherein the amino acid residue abbreviations used are in accordance with the standard peptide nomenclature:  
         
           
             
                   
                   
                   
                   
                 
                       
                       
                   
                       
                     Gly = Glycine; 
                     Ile = Isoleucine; 
                       
                   
                       
                       
                   
                       
                     Glu = Glutamic Acid; 
                     Phe = Phenylalanine; 
                   
                       
                       
                   
                       
                     Cys = Cysteine 
                     Arg = Arginine; 
                   
                       
                       
                   
                       
                     Gln = Glutamine; 
                     Leu = Leucine; 
                   
                       
                       
                   
                       
                     Ser = Serine; 
                     Val = Valine; 
                   
                       
                       
                   
                       
                     Lys = Lysine; 
                     Ala = Alanine; 
                   
                       
                       
                   
                       
                     Asp = Aspartic acid; 
                     His = Histidine; 
                   
                       
                       
                   
                       
                     Orn = Ornithine; 
                     Tyr = Tyrosine; 
                   
                       
                       
                   
                       
                     Pen = Penicillamine 
                   
                       
                       
                   
                       
                     (β,β′-/Dimethyl-Cysteine) 
                   
                       
                       
                   
               
                  
                  
                  
                  
                  
                  
                  
                  
                  
                  
                  
                  
                  
                  
                  
                  
                  
                  
                  
                  
                  
                 
              
             
           
         
         wherein all amino acids, except for glycine, are of the L-absolute configuration, unless indicated as D-absolute configuration, and the peptide has a cyclic disulfide bond between Cys(192) and Cys(189) or Pen(182) and Pen(189) as appropriate;  
         or an organic or inorganic acid addition salt thereof.  
       
     
     
         10 . The method of  claim 9  wherein said peptide comprises amino acids at positions 183 and 186 which are joined by a salt bridge, and are (X and Y) or (Y and X), respectively, where: 
 X is a positively charged amino acid, and  
 Y is a negatively charged amino acid.  
 
     
     
         11 . The method of  claim 10  wherein X is selected from the group consisting of L- or D-Arg, Lys or Om, and Y is selected from the group consisting of L- or D- Asp or Glu.  
     
     
         12 . The method of  claim 1  wherein the animal is a human.  
     
     
         13 . The method of  claim 1  wherein the peptide is administered orally.  
     
     
         14 . A peptide which comprises an analogue of the carboxyl-terminal sequence of a growth hormone, said carboxyl-terminal sequence containing 
 (A) amino acid residues 177-191 of human growth hormone;                              Leu-Arg-Ile-Val-Gln-Cys-Arg-Ser-Val-   (SEQ ID NO: 1)               Glu-Gly-Ser-Cys-Gly-Phe,                           or    (B) a corresponding sequence of a non-human mammalian growth hormone; wherein in said analogue 
 (i) amino acids at positions 182 and 189 of hGH are joined by a bond to promote a cyclic conformation; and/or  
 (ii) amino acids at positions 183 and 186 of hGH are joined by a salt bridge or a covalent bond;  
   or an organic or inorganic acid addition salt thereof.    
     
     
         15 . The peptide of  claim 14 , wherein the bond between amino acids at positions 182 and 189 is a disulfide bond.  
     
     
         16 . The peptide of  claim 14 , wherein the amino acids at positions 182 and 189 are selected from the group consisting of L-Cys, D-Cys, L-Pen and D-Pen.  
     
     
         17 . The peptide of  claim 14 , wherein the amino acids at positions 183 and 186 are joined by a salt bridge, and are (X and Y) or (Y and X), respectively, where: 
 X is a positively charged amino acid, and    Y is a negatively charged amino acid.    
     
     
         18 . The peptide of  claim 17 , wherein X is selected from the group consisting of L- or D-Arg, Lys or Om, and Y is selected from the group consisting of L- or D- Asp or Glu.  
     
     
         19 . The peptide of  claim 14 , wherein the amino acids at positions 183 and 186 are joined by an amide covalent bond.  
     
     
         20 . The peptide of  claim 19 , wherein the amino acids at positions 183 and 186 are (X and Y) or (Y and X), respectively, where: 
 X is selected from the group consisting of L- or D- Lys or Orn, and    Y is selected from the group consisting of L- or D- Asp and Glu.    
     
     
         21 . A peptide of the sequence:  
       
         
           
                 
                 
                 
               
                     
                 
                   Y 1 -Leu-Arg-Ile-Val-Gln-Cys-Arg-Ser- 
                   (SEQ ID NO: 3) 
                     
                 
                     
                 
                   Val-Glu-Gly-Ser-Cys-Gly-Phe 
                 
                     
                 
             
                
                
                
                
                
               
            
           
         
         wherein Y 1  is selected from the group consisting of the desamino form (H), acetyl (CH 3 CO—) and other acyl groups;  
         or a cyclic disulfide thereof or an organic or inorganic acid addition salt thereof.  
       
     
     
         22 . A peptide of the sequence:  
       
         
           
                 
                 
                 
               
                     
                 
                   Leu-Arg-Ile-Val-Gln-Cys-Arg-Ser-Val-Glu-Gly-Ser-Cys-Gly-Phe-Y 2   
                   (SEQ ID NO:4) 
                     
                 
                     
                 
             
                
                
                
               
            
           
         
         wherein Y 2  is selected from the group consisting of CONH 2  and alkyl amide groups;  
         or a cyclic disulfide thereof or an organic or inorganic acid addition salt thereof.  
       
     
     
         23 . A pharmaceutical composition for use in the treatment of obesity in an animal, which comprises an effective amount of the peptide of  claim 14 , together with one or more pharmaceutically acceptable carriers and/or diluents  
     
     
         24 . A peptide analogue of amino acid residues 177-191 of human growth hormone, of the formula;  
       
         
           
                 
                 
               
                     
                 
                   X 0 -X 1 -X 2 -Arg-X 3 -X 4 -X 5 -Cys-Arg-X 6 -X 7 -Glu-X 8 -X 9 -Cys-X 10 -X 11 -X 12   
                     
                 
                     
                 
             
                
                
                
               
            
           
         
         wherein X 0  is des-X 0  or any number of one to ten amino acids; X 1  is des-X 1  or any amino acid, X 2  is des-X 2  or any amino acid; X 3  is des-X 3  or any number of one to three amino acids, X 4  is any amino acid; X 5  is any amino acid; X 6  is des-X 6  or any number of one to three amino acids; X 7  is any amino acid; X 8  is des-X 8  or any number of one to three amino acids; X 9  is any amino acid; X 10  is any amino acid; X 11  is any amino acid; X 12  is des-X 12 , or any number of one to ten amino acids, but excludes hGH177-191, hGH176-191 and hGH172-191.  
       
     
     
         25 . The peptide analogue of  claim 24  wherein X 0  is des-X 0  or Lys; X 1  is des-X 1 , CH 3 CO, H, Tyr, or Lys; X 2  is Leu or Ala; X 3  is Ile, Lys, or Ala; X 4  is Val or Ala; X 5  is Gln or Ala; X 6  is Ser or Ala; X 7  is Val or Ala; X 8  is Gly, Ala, or D-Ala; X 9  is Ser or Ala; X 10  Gly, Ala, or D-Ala; X 11  is Phe or Ala; X 12  is des-X 12 , or any amino acid.  
     
     
         26 . A peptide analogue of amino acid residues 177-191 of human growth hormone, of the formula;  
         
     
     
         27 . The peptide analogue of 26 wherein X 0  is des-X 0  or Lys; X 1  is des-X 1 , CH 3 CO, H, Tyr, or Lys; X 2  is Leu or Ala; X 3  is Ile, Lys, or Ala; X 4  is Val or Ala; X 5  is Gln or Ala; X 6  is Ser or Ala; X 7  is Val or Ala; X 8  is Gly, Ala, or D-Ala; X 9  is Ser or Ala; X 10  Gly, Ala, or D-Ala; X 11  is Phe or Ala; X 12  is des-X 12 , or any amino acid.  
     
     
         28 . A peptide analogue of amino acid residues 177-191 of human growth hormone, of the formula;  
       
         
           
                 
                 
               
                     
                 
                   X 0 -X 1 -X 2 -Lys-X 3 -X 4 -X 5 -Cys-Arg-X 6 -X 7 -Glu-X 8 -X 9 -Cys-X 10 -X 11 -X 12   
                     
                 
                     
                 
             
                
                
                
               
            
           
         
         wherein X 0  is des-X 0  or any number of one to ten amino acids; X 1  is des-X 1  or any amino acid, X 2  is des-X 2  or any amino acid; X 3  is des-X 3  or any number of one to three amino acids, X 4  is any amino acid; X 5  is any amino acid; X 6  is des-X 6  or any number of one to three amino acids; X 7  is any amino acid; X 8  is des-X 8  or any number of one to three amino acids; X 9  is any amino acid; X 10  is any amino acid; X 11  is any amino acid; X 12  is des-X 12 , or any number of one to ten amino acids, but excludes hGH177-191, hGHI76-191 and hGH172-191.  
       
     
     
         29 . The peptide analogue of  claim 28  wherein X 0  is des-X 0  or Lys; X 1  is des-X 1 , CH 3 CO, H, Tyr, or Lys; X 2  is Leu or Ala; X 3  is Ile, Lys, or Ala; X 4  is Val or Ala; X 5  is Gln or Ala; X 6  is Ser or Ala; X 7  is Val or Ala; X 8  is Gly, Ala, or D-Ala; X 9  is Ser or Ala; X 10  Gly, Ala, or D-Ala; X 11  is Phe or Ala; X 12  is des-X 12 , or any amino acid.  
     
     
         30 . A peptide analogue of amino acid residues 177-191 of human growth hormone, of the formula;  
       
         
           
                 
                 
               
                     
                 
                   X 0 -X 1 -X 2 -Arg-X 3 -X 4 -X 5 -Cys-Lys-X 6 -X 7 -Glu-X 8 -X 9 -Cys-X 10 -X 11 -X 12   
                     
                 
                     
                 
             
                
                
                
               
            
           
         
         wherein X 0  is des-X 0  or any number of one to ten amino acids; X 1  is des-X 1  or any amino acid, X 2  is des-X 2  or any amino acid; X 3  is des-X 3  or any number of one to three amino acids, X 4  is any amino acid; X 5  is any amino acid; X 6  is des-X 6  or any number of one to three amino acids; X 7  is any amino acid; X 8  is des-X 8  or any number of one to three amino acids; X 9  is any amino acid; X 10  is any amino acid; X 11  is any amino acid; X 12  is des-X 12 , or any number of one to ten amino acids, but excludes hGH177-191, hGH176-191 and hGH172-191.  
       
     
     
         31 . The peptide analogue of  claim 30  wherein X 0  is des-X 0  or Lys; X 1  is des-X 1 , CH 3 CO, H, Tyr, or Lys; X 2  is Leu or Ala; X 3  is Ile, Lys, or Ala; X 4  is Val or Ala; X 5  is Gln or Ala; X 6  is Ser or Ala; X 7  is Val or Ala; X 8  is Gly, Ala, or D-Ala; X 9  is Ser or Ala; X 10  Gly, Ala, or D-Ala; X 11  is Phe or Ala; X 12  is des-X 12 , or any amino acid.

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