Methods for treating hypophosphatemic disorders

• US 10,639,360 B2
• Filed: 05/29/2015
• Issued: 05/05/2020
• Est. Priority Date: 06/09/2014
• Status: Active Grant

• Current Assignee: Kyowa Kirin Co., Ltd. (Kirin Holdings Company Limited), Ultragenyx Pharmaceutical Inc.
• Original Assignee: Ultragenyx Pharmaceutical Inc.
• Inventors: Kakkis, Emil D., San Martin, Javier, Sudo, Tomohiro
• Primary Examiner(s): Saoud, Christine J
• Application Number:
  US14/725,320
• Publication Number:
  US 20150353633A1
• Time in Patent Office: 1,803 Days
• Field of Search: None
• CPC Class Codes: A61K 2039/505 comprising antibodies
• CPC Class Codes: A61K 2039/54 characterised by the route of administration
• CPC Class Codes: A61K 2039/545 characterised by the dose, timing or administration schedule
• CPC Class Codes: A61K 39/001132 Fibroblast growth factors [FGF]
• CPC Class Codes: A61P 19/08 for bone diseases, e.g. rachitism, Paget's disease
• CPC Class Codes: C07K 16/22 against growth factors ; against growth regulators
• CPC Class Codes: C07K 2317/21 from primates, e.g. man
• CPC Class Codes: C07K 2317/565 Complementarity determining region [CDR]
• CPC Class Codes: C07K 2317/76 Antagonist effect on antigen, e.g. neutralization or inhibition of binding
• CPC Class Codes: C07K 2317/90 characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin

Abstract

The present invention provides compositions and methods for treating a hypophosphatemic disorder, such as X-linked hypophosphatemia (XLH). The method entails administering to a subject a pharmaceutical composition containing an anti-FGF23 ligand, wherein the dosing regimen of the pharmaceutical is designed to reach effective and efficient control of FGF23 activity.

Claims

1. A method of treating a hypophosphatemic disorder associated with abnormal fibroblast growth factor 23 (FGF23) levels and/or activity, comprising administering to a subject in need of such treatment an effective amount of an anti-FGF23 antibody, wherein the anti-FGF23 antibody is administered about every two weeks, and wherein the anti-FGF23 antibody comprises the CDR sequences of SEQ ID NO:

1, SEQ ID NO;

2, SEQ ID NO;

3, SEQ ID NO;

4, SEQ ID NO;

5, and SEQ ID NO;

6.

2. The method of claim 1, wherein the hypophosphatemic disorder is selected from the group consisting of autosomal dominant hypophosphatemic rickets (ADHR), X-linked hypophosphatemia (XLH), autosomal recessive hypophosphatemic rickets (ARHR), fibrous dysplasia (FD), McCune-Albright syndrome complicated by fibrous dysplasia (MAS/FD), Jansen'"'"'s metaphyseal chondrodysplasia (Jansen'"'"'s Syndrome), autosomal dominant polycystic kidney disease (ADPKD), tumor-induced osteomalacia (TIO), and chronic metabolic acidosis.

3. The method of claim 1, wherein the hypophosphatemic disorder is XLH.

4. The method of claim 1, wherein the hypophosphatemic disorder is TIO.

5. The method of claim 1, wherein the heavy chain of the anti-FGF23 antibody comprises a sequence of SEQ ID NO:

7.

6. The method of claim 1, wherein the light chain of the anti-FGF23 antibody comprises a sequence of SEQ ID NO:

8.

7. The method of claim 1, wherein the heavy chain of the anti-FGF23 antibody comprises a sequence of SEQ ID NO:

7 and the light chain of the anti-FGF23 antibody comprises a sequence of SEQ ID NO;

8.

8. The method of claim 1, wherein the anti-FGF23 antibody is administered parenterally, subcutaneously, intravenously, intramuscularly, or intraperitoneally.

9. The method of claim 8, wherein the anti-FGF23 antibody is administered subcutaneously.

10. The method of claim 1, wherein the anti-FGF23 antibody is administered with a pharmaceutically-acceptable carrier.

11. The method of claim 1, wherein the subject is a human.

12. The method of claim 11, wherein the subject is a pediatric subject.

13. The method of claim 1, wherein the anti-FGF23 antibody is administered at a dose of about 0.8 mg/kg.

14. The method of claim 1, wherein the anti-FGF23 antibody is administered at a dose of about 1.0 mg/kg.