IP Library › Granted Patent US 12,358,976
Granted Patent B2
US 12,358,976 · App. 18/366,447 · Granted Jul 15, 2025

Methods for increasing serum concentration of phosphorous and/or 1,25-hydroxy vitamin d

Inventors: Emil D. Kakkis (Novato, CA); Javier San Martin (Novato, CA); Tomohiro Sudo (Tokyo, JP)
Assignees: Ultragenyx Pharmaceutical Inc.; Kyowa Kirin Co., Ltd.
C07K16/22A61K39/001132A61K2039/505A61K2039/54A61K2039/545C07K2317/21C07K2317/565C07K2317/76C07K2317/90
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Quick Facts
Patent No.
US 12,358,976
App. No.
18/366,447
Granted
Jul 15, 2025
Kind
B2
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 (20)

1. A method of increasing serum phosphorus levels in a subject having a hypophosphatemic disorder, said method comprising administering to the subject 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 heavy chain of the anti-FGF23 antibody comprises a sequence of SEQ ID NO: 7.

3. The method of claim 1 , wherein the light chain of the anti-FGF23 antibody comprises a sequence of SEQ ID NO: 8.

4. 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.

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

6. The method of claim 1 , wherein the subject is a pediatric subject.

7. The method of claim 1 , wherein the anti-FGF23 antibody is administered subcutaneously.

8. The method of claim 1 , wherein the anti-FGF23 antibody is administered at a dose from about 0.05 mg/kg to about 1.0 mg/kg.

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

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

11. 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.

12. The method of claim 11 , wherein the hypophosphatemic disorder is XLH.

13. The method of claim 11 , wherein the hypophosphatemic disorder is TIO.

14. A method of increasing serum 1,25-dihydroxy vitamin D levels in a subject having a hypophosphatemic disorder, said method comprising administering to the subject 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.

15. The method of claim 14 , 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.

16. The method of claim 14 , wherein the subject is a pediatric subject.

17. The method of claim 14 , wherein the anti-FGF23 antibody is administered subcutaneously.

18. The method of claim 14 , 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.

19. The method of claim 18 , wherein the hypophosphatemic disorder is selected from XLH and TIO.

20. A method of increasing serum concentrations of phosphorus and/or 1,25-dihydroxy vitamin D in a subject having a hypophosphatemic disorder, said method comprising administering to the subject 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.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 9, 2023
From: SUDO, TOMOHIRO
To: KYOWA HAKKO KIRIN CO., LTD.
Reel/Frame 065161/0233 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 9, 2023
From: KAKKIS, EMIL D.; MARTIN, JAVIER SAN
To: ULTRAGENYX PHARMACEUTICAL INC.
Reel/Frame 065161/0459 →
CHANGE OF NAME Recorded Oct 9, 2023
From: KYOWA HAKKO KIRIN CO., LTD.
To: KYOWA KIRIN CO., LTD.
Reel/Frame 065190/0403 →
Continuity (5)
Continuation 17525738 · Nov 12, 2021
Continuation 16831179 · Mar 26, 2020
Continuation 14725320 · May 29, 2015
Provisional Application 62009474 · Jun 9, 2014
Related Publication 20240115683A1 · Apr 11, 2024
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