IP Library Granted Patent US 11,072,640
Granted Patent B2
US 11,072,640 · App. 15/996,232 · Granted Jul 27, 2021

Methods of treating non-alcoholic steatohepatitis using FGF21 mutants

Inventors: Edward John Belouski (Thousand Oaks, CA); Murielle Marie Ellison (Thousand Oaks, CA); Agnes Eva Hamburger (Newbury Park, CA); Randy Ira Hecht (Raleigh, NC); Yue-Sheng Li (Cambridge, MA); Mark Leo Michaels (Encino, CA); Jeonghoon Sun (San Diego, CA); Jing Xu (Thousand Oaks, CA)
Assignee: AMGEN INC.
C07K14/50A61K38/1825A61K38/00A61K2039/505C07K16/18C07K2319/30
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Quick Facts
Patent No.
US 11,072,640
App. No.
15/996,232
Granted
Jul 27, 2021
Kind
B2
Abstract

The invention provides methods for treating non-alcoholic steatohepatitis (NASH) using FGF21 mutant polypeptides.

Claims (15)

1. A method of treating non-alcoholic steatohepatitis (NASH) comprising administering to a human patient in need thereof a therapeutically effective amount of a pharmaceutical composition comprising a polypeptide comprising the amino acid sequence of SEQ ID NO:4 comprising:

(a) a substitution of an arginine residue for the leucine residue at position 98;

(b) a substitution of a glycine residue for the proline residue at position 171; and

(c) a substitution of a glutamic acid residue for the alanine residue at position 180.

2. The method of claim 1 , wherein the polypeptide comprises 1 to 10 amino acid residues fused to the C-terminus of the polypeptide.

3. The method of claim 1 , wherein the polypeptide is covalently linked to one or more polymers.

4. The method of claim 3 , wherein the polypeptide is covalently linked to PEG.

5. The method of claim 1 , wherein the polypeptide is fused to a heterologous amino acid sequence.

6. The method of claim 5 , wherein the polypeptide is fused to the heterologous amino acid sequence via a linker.

7. The method of claim 6 , wherein the linker comprises GGGGGSGGGSGGGGS (SEQ ID NO: 23).

8. The method of claim 6 , wherein the linker comprises GGGGSGGGGSGGGGS (SEQ ID NO: 31).

9. The method of claim 8 , wherein the heterologous amino acid sequence is an IgG constant domain or fragment thereof.

10. The method of claim 9 , wherein the IgG constant domain comprises the amino acid sequence of SEQ ID NO:13.

11. The method of claim 6 , wherein the heterologous amino acid sequence is an IgG constant domain or fragment thereof.

12. The method of claim 11 , wherein the IgG constant domain comprises the amino acid sequence of SEQ ID NO:13.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 26, 2018
From: BELOUSKI, EDWARD JOHN; ELLISON, MURIELLE MARIE; HAMBURGER, AGNES EVA; HECHT, RANDY IRA; LI, YUE-SHENG; MICHAELS, MARK LEO; SUN, JEONGHOON; XU, JING
To: AMGEN INC.
Reel/Frame 047853/0751 →
Continuity (10)
Continuation 15004281 · Jan 22, 2016
Continuation 14134482 · Dec 19, 2013
Division 13327504 · Dec 15, 2011
Division 13196544 · Aug 2, 2011
Continuation 12455610 · Jun 3, 2009
Provisional Application 61175736 · May 5, 2009
Provisional Application 61164364 · Mar 27, 2009
Provisional Application 61058861 · Jun 4, 2008
Provisional Application 61058919 · Jun 4, 2008
Related Publication 20190023757A1 · Jan 24, 2019
Cited By (2)
US 12,668,774 US 12,686,847