IP Library Granted Patent US 9,987,262
Granted Patent B2
US 9,987,262 · App. 15/608,186 · Granted Jun 5, 2018

Solid forms of {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid, compositions, and uses thereof

Inventors: James Densmore Copp (Silverthorne, CO); Ann W. Newman (Lafayette, IN); Anne Luong (Mississauga, CA)
Assignee: Akebia Therapeutics, Inc.
A61K31/444A61K9/14A61K9/48C07D213/803C07D213/81C07D221/00
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Quick Facts
Patent No.
US 9,987,262
App. No.
15/608,186
Granted
Jun 5, 2018
Kind
B2
Abstract

Provided herein are solid forms comprising {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid, compositions comprising the solid forms, methods of making the solid forms and methods of their use for the treatment of various diseases and/or disorders.

Claims (23)

1. A method for treating anemia, comprising administering a therapeutically effective amount of a crystalline Compound (I):

which has an X-ray powder diffraction pattern comprising peaks at 18.1, 20.3, 22.9, 24.0, and 26.3±0.2 °2θ;

to a patient having anemia.

2. A method for treating anemia, comprising administering a pharmaceutical composition comprising a therapeutically effective amount of a crystalline Compound (I):

which has an X-ray powder diffraction pattern comprising peaks at 18.1, 20.3, 22.9, 24.0, and 26.3±0.2 °2θ;

to a patient having anemia.

3. The method of claim 1 , wherein the anemia is anemia secondary to or associated with chronic kidney disease.

4. The method of claim 2 , wherein the anemia is anemia secondary to or associated with chronic kidney disease.

5. The method of claim 1 , wherein the crystalline compound comprises less than 5% by weight of any other crystalline form of Compound (I).

6. The method of claim 2 , wherein the pharmaceutical composition comprises less than 5% by weight of any other crystalline form of Compound (I).

7. The method of claim 5 , wherein the anemia is anemia secondary to or associated with chronic kidney disease.

8. The method of claim 6 , wherein the anemia is anemia secondary to or associated with chronic kidney disease.

9. The method of claim 1 , wherein the crystalline Compound (I) is at least 99.5% pure as measured by HPLC.

10. The method of claim 1 , wherein the therapeutically effective amount of the crystalline Compound (I) comprises less than 100 ppm of a compound of Formula (II):

as determined by GC/MS.

11. The method of claim 1 , wherein the therapeutically effective amount of the crystalline Compound (I) comprises less than 5% by weight of any amorphous form of Compound (I).

12. The method of claim 2 , wherein the crystalline Compound (I) is at least 99.5% pure as measured by HPLC.

13. The method of claim 2 , wherein the pharmaceutical composition comprises less than 100 ppm of a compound of Formula (II):

as determined by GC/MS.

14. The method of claim 2 , wherein the pharmaceutical composition comprises less than 5% by weight of amorphous form of Compound (I).

15. A method for treating anemia, comprising administering a therapeutically effective amount of a crystalline Compound (I):

which has an X-ray powder diffraction pattern as shown in FIG. 1 ,

to a patient having anemia.

Assignments (2)
SECURITY INTEREST Recorded Jan 29, 2024
From: AKEBIA THERAPEUTICS, INC.; KERYX BIOPHARMACEUTICALS, INC.
To: KREOS CAPITAL VII (UK) LIMITED
Reel/Frame 066377/0654 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 31, 2017
From: COPP, JAMES DENSMORE; NEWMAN, ANN W.; LUONG, ANNE
To: AKEBIA THERAPEUTICS, INC.
Reel/Frame 042537/0118 →
Continuity (3)
Division 14541284 · Nov 14, 2014
Provisional Application 61904803 · Nov 15, 2013
Related Publication 20170258773A1 · Sep 14, 2017