IP Library Granted Patent US 9,072,708
Granted Patent B2
US 9,072,708 · App. 14/526,058 · Granted Jul 7, 2015

Methods for treating metabolic disorders using FGF

Inventors: Johan W. Jonker (Gronigen, NL); Michael Downes (San Diego, CA); Ronald M. Evans (La Jolla, CA); Jae Myoung Suh (San Diego, CA)
Assignee: Salk Institute for Biological Studies
A61K38/1825A61K45/06
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Quick Facts
Patent No.
US 9,072,708
App. No.
14/526,058
Granted
Jul 7, 2015
Kind
B2
Abstract

The method provides methods and compositions for treating metabolic disorders such as impaired glucose tolerance, elevated blood glucose, insulin resistance, dyslipidaemia, obesity, and fatty liver.

Claims (44)

1. A method for treating a diabetic, hyperglycemic, and/or insulin resistant individual who has a body mass index (BMI) of 25 or higher, comprising systemically administering an FGF-1 compound having at least 80% identity to human FGF-1 to the individual in an amount effective to reduce body fat in the individual and/or increase lean muscle mass in the individual.

2. The method of claim 1 , wherein the FGF-1 compound is administered intravenously.

3. The method of claim 1 , wherein the FGF-1 compound is administered subcutaneously.

4. The method of claim 1 , wherein the FGF-1 compound is administered in combination with an additional therapeutic compound.

5. The method of claim 4 , wherein the additional therapeutic compound is an alpha-glucosidase inhibitor, amylin agonist, dipeptidyl-peptidase 4 (DPP-4) inhibitor, meglitinide, sulfonylurea, or a peroxisome proliferator-activated receptor (PPAR)-gamma agonist.

6. The method of claim 5 , wherein the PPAR-gamma agonist is a thiazolidinedione (TZD), aleglitazar, farglitazar, muraglitazar, or tesaglitazar.

7. The method of claim 6 , wherein the TZD is pioglitazone, rosiglitazone, rivoglitazone, or troglitazone.

8. The method of claim 1 , wherein the FGF-1 compound is a functional fragment of FGF-1 comprising at least 80% of human FGF-1.

9. The method of claim 8 , wherein the functional fragment of FGF-1 comprising at least 80% of human FGF-1 comprises at least 80% sequence identity to amino acids 1-140, amino acids 1-141, amino acids 14-135, or amino acids 13-135 of FGF1.

10. The method of claim 8 , wherein the functional fragment of FGF-1 comprising at least 80% of human FGF-1 comprises amino acids 1-140, amino acids 1-141, amino acids 14-135, or amino acids 13-135 of FGF-1.

11. The method of claim 8 , wherein the functional fragment of FGF-1 comprising at least 80% of human FGF-1 consists of amino acids 1-140, amino acids 1-141, amino acids 14-135, or amino acids 13-135 of FGF-1.

12. The method of claim 8 , wherein the functional fragment of FGF-1 comprising at least 80% of human FGF-1 comprises at least 80% sequence identity to amino acids 14-135 of FGF-1.

13. The method of claim 8 , wherein the functional fragment of FGF-1 comprising at least 80% of human FGF-1 comprises amino acids 14-135 of FGF-1.

14. The method of claim 8 , wherein the functional fragment of FGF-1 comprising at least 80% of human FGF-1 consists of amino acids 14-135 of FGF-1.

15. The method of claim 8 , wherein the functional fragment of FGF-1 comprising at least 80% of human FGF-1 comprises at least 90% sequence identity to amino acids 1-141 of FGF-1.

16. The method of claim 8 , wherein the functional fragment of FGF-1 comprising at least 80% of human FGF-1 comprises at least 95% sequence identity to amino acids 1-141 of FGF-1.

17. The method of claim 8 , wherein the functional fragment of FGF-1 comprising at least 80% of human FGF-1 comprises at least 98% sequence identity to amino acids 1-141 of FGF-1.

18. The method of claim 1 , wherein the FGF-1 compound is administered daily, twice daily, every other day, bi-weekly, weekly, or monthly.

19. The method of claim 1 , wherein the FGF-1 compound is at least 90% identical to mature human FGF-1.

20. The method of claim 1 , wherein the FGF-1 compound is a functional fragment of FGF-1 consisting of at least 90% of mature human FGF-1.

21. The method of claim 1 , wherein the individual has a BMI of greater than 30.

22. The method of claim 1 , wherein the individual has a BMI of 35 to 40.

23. The method of claim 1 , wherein the individual has a BMI of 40 or greater.

24. A method for treating a diabetic, hyperglycemic, and/or insulin resistant individual who has a fatty liver disease, comprising systemically administering an FGF-1 compound having at least 80% identity to human FGF-1 to the individual in an amount effective to reduce liver steatosis.

25. The method of claim 24 , wherein the fatty liver disease is nonalcoholic steatohepatitis (NASH), nonalcoholic fatty liver disease (NAFLD), or simple fatty liver (steatosis).

26. The method of claim 24 , wherein the FGF-1 compound is administered intravenously.

27. The method of claim 24 , wherein the FGF-1 compound is administered subcutaneously.

28. The method of claim 24 , wherein the FGF-1 compound is administered in combination with an additional therapeutic compound.

29. The method of claim 28 , wherein the additional therapeutic compound is an alpha-glucosidase inhibitor, amylin agonist, dipeptidyl-peptidase 4 (DPP-4) inhibitor, meglitinide, sulfonylurea, or a peroxisome proliferator-activated receptor (PPAR)-gamma agonist.

30. The method of claim 29 , wherein the PPAR-gamma agonist is a thiazolidinedione (TZD), aleglitazar, farglitazar, muraglitazar, or tesaglitazar.

31. The method of claim 30 , wherein the TZD is pioglitazone, rosiglitazone, rivoglitazone, or troglitazone.

32. The method of claim 24 , wherein the FGF-1 compound is a functional fragment of FGF-1 comprising at least 80% of human FGF-1.

33. The method of claim 32 , wherein the functional fragment of FGF-1 comprising at least 80% of human FGF-1 comprises at least 80% sequence identity to amino acids 1-140, amino acids 1-141, amino acids 14-135, or amino acids 13-135 of FGF1.

34. The method of claim 32 , wherein the functional fragment of FGF-1 comprising at least 80% of human FGF-1 comprises amino acids 1-140, amino acids 1-141, amino acids 14-135, or amino acids 13-135 of FGF-1.

35. The method of claim 32 , wherein the functional fragment of FGF-1 comprising at least 80% of human FGF-1 consists of amino acids 1-140, amino acids 1-141, amino acids 14-135, or amino acids 13-135 of FGF-1.

36. The method of claim 32 , wherein the functional fragment of FGF-1 comprising at least 80% of human FGF-1 comprises at least 80% sequence identity to amino acids 14-135 of FGF-1.

37. The method of claim 32 , wherein the functional fragment of FGF-1 comprising at least 80% of human FGF-1 comprises amino acids 14-135 of FGF-1.

38. The method of claim 32 , wherein the functional fragment of FGF-1 comprising at least 80% of human FGF-1 consists of amino acids 14-135 of FGF-1.

39. The method of claim 32 , wherein the functional fragment of FGF-1 comprising at least 80% of human FGF-1 comprises at least 90% sequence identity to amino acids 1-141 of FGF-1.

40. The method of claim 32 , wherein the functional fragment of FGF-1 comprising at least 80% of human FGF-1 comprises at least 95% sequence identity to amino acids 1-141 of FGF-1.

41. The method of claim 32 , wherein the functional fragment of FGF-1 comprising at least 80% of human FGF-1 comprises at least 98% sequence identity to amino acids 1-141 of FGF-1.

42. The method of claim 24 , wherein the FGF-1 compound is administered daily, twice daily, every other day, bi-weekly, weekly, or monthly.

43. The method of claim 24 , wherein the FGF-1 compound is at least 90% identical to mature human FGF-1.

44. The method of claim 24 , wherein the FGF-1 compound is a functional fragment of FGF-1 consisting of at least 90% of mature human FGF-1.

Assignments (4)
CONFIRMATORY LICENSE Recorded Mar 17, 2015
From: SALK INSTITUTE FOR BIOLOGICAL STUDIES
To: NATIONAL INSTITUTES OF HEALTH (NIH), U.S. DEPT. OF HEALTH AND HUMAN SERVICES (DHHS), U.S. GOVERNMENT
Reel/Frame 035220/0972 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 29, 2014
From: JONKER, JOHAN W.; DOWNES, MICHAEL; SUH, JAE MYOUNG
To: SALK INSTITUTE FOR BIOLOGICAL STUDIES
Reel/Frame 034061/0446 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 29, 2014
From: EVANS, RONALD M.
To: HOWARD HUGHES MEDICAL INSTITUTE
Reel/Frame 034061/0467 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 29, 2014
From: HOWARD HUGHES MEDICAL INSTITUTE
To: SALK INSTITUTE FOR BIOLOGICAL STUDIES
Reel/Frame 034061/0517 →
Continuity (6)
Division 14184621 · Feb 19, 2014
Division 13641451
Provisional Application 61325255 · Apr 16, 2010
Provisional Application 61325261 · Apr 16, 2010
Provisional Application 61325253 · Apr 16, 2010
Related Publication 20150065419A1 · Mar 5, 2015