Compositions and methods of use for treating metabolic disorders

Patent metadata

Field	Value
Publication number	US-9550819-B2
Application number	US-201314373617-A
Country	US
Kind code	B2
Filing date	Mar 8, 2013
Priority date	Mar 27, 2012
Publication date	Jan 24, 2017
Grant date	Jan 24, 2017

Abstract

Methods of treating individuals with a glucose metabolism disorder and/or a body weight disorder, and compositions associated therewith, are provided.

First claim

What is claimed is:

1. A polypeptide comprising:
the amino acid sequence of SEQ ID NO: 10.

2. The polypeptide of claim 1 , wherein the polypeptide comprises an albumin fusion, Fc-fusion, or fusion with a PEG mimetic.

3. The polypeptide of claim 1 , wherein the polypeptide is pegylated.

4. The polypeptide of claim 3 , wherein the pegylation increases the solubility of the peptide.

5. The polypeptide of claim 1 , wherein the polypeptide is produced recombinantly.

6. A nucleic acid molecule encoding the polypeptide of claim 1 .

7. The nucleic acid molecule of claim 6 , wherein the nucleic acid molecule is operably linked to an expression control element that confers expression of the nucleic acid molecule encoding the polypeptide in vitro, in a cell, or in vivo.

8. A vector comprising the nucleic acid molecule of claim 6 .

9. The vector of claim 8 , wherein the vector comprises a viral vector.

10. A transformed host cell that expresses the polypeptide of claim 1 .

11. A pharmaceutical composition, comprising the polypeptide of claim 1 , and a pharmaceutically acceptable diluent, carrier or excipient.

12. The pharmaceutical composition of claim 11 , further comprising at least one additional prophylactic or therapeutic agent.

13. A sterile container comprising the pharmaceutical composition of claim 11 .

14. The sterile container of claim 13 , wherein the sterile container is a syringe.

15. A kit comprising the sterile container of claim 13 .

16. The kit of claim 15 , further comprising a second sterile container comprising at least one additional prophylactic or therapeutic agent.

17. A method of treating obesity or hyperglycemia in a mammalian subject, comprising administering to the subject a therapeutically effective amount of the polypeptide of claim 1 .

18. The method of claim 17 , wherein the polypeptide comprises an albumin fusion, Fc-fusion, or fusion with a PEG mimetic.

19. The method of claim 17 , wherein the polypeptide is pegylated.

20. The method of claim 19 , wherein the pegylation increases solubility.

21. The method of claim 17 , wherein the method comprises treating hyperglycemia in a mammalian subject and wherein the administering results in a reduction in blood glucose in the subject.

22. The method of claim 17 , wherein the treating comprises a reduction in body weight in the subject.

23. The method of claim 17 , wherein the treating comprises a reduction in food intake in the subject.

24. The method of claim 17 , wherein the subject has diabetes mellitus.

25. The method of claim 17 , wherein the subject is human.

26. The method of claim 25 , wherein the subject is obese.

27. The method of claim 17 , wherein the administering is by parenteral injection.

28. The method of claim 27 , wherein the parenteral injection is subcutaneous.

29. The method of claim 21 , wherein the polypeptide is pegylated.

30. The method of claim 22 , wherein the polypeptide is pegylated.

31. The method of claim 23 , wherein the polypeptide is pegylated.

32. The method of claim 24 , wherein the polypeptide is pegylated.

33. The method of claim 26 , wherein the polypeptide is pegylated.

Assignees

• Ngm Biopharmaceuticals Inc

Inventors

• Lindhout Darrin Anthony
• Zhang Peng
• Parsons Thomas Frederick

Classifications

• A61P3/08

  for glucose homeostasis (pancreatic hormones A61P5/48) · CPC title

• A61P3/10

  for hyperglycaemia, e.g. antidiabetics · CPC title

• A61K38/38

  Albumins · CPC title

• A61K39/3955

  against proteinaceous materials, e.g. enzymes, hormones, lymphokines · CPC title

• A61K45/06

  Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca · CPC title