Amylases for pharmaceutical use
View Patent ↗The pharmaceutical use of amylases related to Bacillus alpha-amylases of SEQ ID NOs: 1-3, optionally in combination with a lipase and/or a protease. Examples of medical indications are: Treatment of digestive disorders, pancreatic exocrine insufficiency (PEI), pancreatitis, cystic fibrosis, diabetes type I, and/or diabetes type II. The amylases of SEQ ID NOs: 1-3 are variants of amylases from Bacillus stearothermophilus, Bacillus licheniformis and Bacillus sp. The amylases of the invention have an improved efficacy in vivo, an improved pH-profile, a high specific activity, and/or an improved starch degradation profile.
1. A method for the treatment of digestive disorders, pancreatic exocrine insufficiency, pancreatitis, cystic fibrosis, diabetes type I, and/or diabetes type II, by administering an effective amount of an amylase having at least 95% identity to (i) amino acids 1-481 of SEQ ID NO: 1, (ii) amino acids 1-481 of SEQ ID NO: 2, and/or (iii) amino acids 1-483 of SEQ ID NO: 3 to an animal in need thereof.
2. The method of claim 1 , further comprising administering an effective amount of a lipase or a protease to the animal.
3. The method of claim 1 , further comprising administering an effective amount of a lipase and a protease to the animal.
4. The method of claim 2 , wherein the protease has at least 95% identity to a protease selected from the group consisting of:
(a) a protease having amino acids 1-274 of SEQ ID NO: 5,
(b) a protease having amino acids 1-188 of SEQ ID NO: 6, and
(c) a protease having amino acids 1-188 of SEQ ID NO: 7.
5. The method of claim 2 , wherein the protease is selected from the group consisting of:
a) a protease comprising amino acids 1-274 of SEQ ID NO: 5,
b) a protease comprising amino acids 1-188 of SEQ ID NO: 6, and
c) a protease comprising amino acids 1-188 of SEQ ID NO: 7.
6. The method of claim 1 , wherein the amylase has an amino acid sequence selected from the group consisting of (i) amino acids 1-481, 1-484, 1-486, or 1-513 of SEQ ID NO: 1, (ii) amino acids 1-481 of SEQ ID NO: 2, and/or (iii) amino acids 1-483 of SEQ ID NO: 3.
7. The method of claim 1 , wherein the amylase has an amino acid sequence consisting of amino acids 1-481, 1-484, 1-486, or 1-513 of SEQ ID NO: 1.
8. The method of claim 1 , wherein the amylase has an amino acid sequence consisting of amino acids 1-481 of SEQ ID NO: 2.
9. The method of claim 1 , wherein the amylase has an amino acid sequence consisting of amino acids amino acids 1-483 of SEQ ID NO: 3.
10. A method of treating pancreatic exocrine insufficiency comprising administering an effective amount of an amylase having at least 95% identity to (i) amino acids 1-481 of SEQ ID NO: 1, (ii) amino acids 1-481 of SEQ ID NO: 2, and/or (iii) amino acids 1-483 of SEQ ID NO: 3 to an animal in need thereof.
11. The method of claim 10 , wherein the amylase has an amino acid sequence selected from the group consisting of (i) amino acids 1-481, 1-484, 1-486, or 1-513 of SEQ ID NO: 1, (ii) amino acids 1-481 of SEQ ID NO: 2, and/or (iii) amino acids 1-483 of SEQ ID NO: 3.
12. The method of claim 10 , wherein the amylase has an amino acid sequence consisting of amino acids 1-481, 1-484, 1-486, or 1-513 of SEQ ID NO: 1.
13. The method of claim 10 , wherein the amylase has an amino acid sequence consisting of amino acids 1-481 of SEQ ID NO: 2.
14. The method of claim 10 , wherein the amylase has an amino acid sequence consisting of amino acids amino acids 1-483 of SEQ ID NO: 3.
15. The method of claim 10 , further comprising administering an effective amount of a lipase or a protease.
16. The method of claim 15 , wherein the protease has at least 95% identity to a protease selected from the group consisting of:
(a) a protease having amino acids 1-274 of SEQ ID NO: 5,
(b) a protease having amino acids 1-188 of SEQ ID NO: 6, and
(c) a protease having amino acids 1-188 of SEQ ID NO: 7.
17. The method of claim 15 , wherein the protease is selected from the group consisting of:
a) a protease comprising amino acids 1-274 of SEQ ID NO: 5,
b) a protease comprising amino acids 1-188 of SEQ ID NO: 6, and
c) a protease comprising amino acids 1-188 of SEQ ID NO: 7.
18. The method of claim 1 , wherein the animal is human.
19. The method of claim 10 , wherein the animal is human.
20. The method of claim 10 , further comprising administering an effective amount of a lipase and a protease to the animal.