IP Library › Granted Patent US 12,291,556
Granted Patent B2
US 12,291,556 · App. 18/116,766 · Granted May 6, 2025

Parathyroid hormone variants

Inventors: Clark Pan (Sudbury, MA); Angela Norton (Reading, MA); Kevin Holmes (Belmont, MA); David Lloyd (Leland, NC); Bryan Goodwin (Lexington, MA); Rongxin Shi (Waltham, MA); Sujit Jain (Lexington, MA); Chuan Shen (West Roxbury, MA)
Assignee: TAKEDA PHARMACEUTICAL COMPANY LIMITED
C07K14/635A61K9/0014A61P5/18C07K1/165A61K38/00C07K2319/30
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Quick Facts
Patent No.
US 12,291,556
App. No.
18/116,766
Granted
May 6, 2025
Kind
B2
Abstract

The invention relates to parathyroid hormone (PTH) variants and pharmaceutical compositions comprising same. The invention further relates to PTH compositions with improved serum half-life and peak-trough ratios, and methods of controlling serum calcium levels with the PTH variants and compositions of the invention. The invention further relates to methods of treating hypoparathyroidism and/or hypocalcemia due to hypoparathyroidism with the PTH variants and compositions of the invention.

Claims (17)

1. A method of increasing serum calcium levels in a subject in need thereof comprising administering to the subject an effective amount of a parathyroid hormone (PTH)-Fc fusion protein, wherein the PTH-Fc fusion protein is PTH-66 having the amino acid sequence of SEQ ID NO: 8.

2. The method of claim 1 , wherein the subject has hypoparathyroidism.

3. The method of claim 1 , wherein the PTH-Fc fusion protein is administered subcutaneously.

4. The method of claim 1 , wherein the PTH-Fc fusion protein is administered once daily.

5. The method of claim 1 , wherein the PTH-Fc fusion protein is administered once weekly.

6. The method of claim 1 , wherein the PTH-Fc fusion protein is provided to the subject in an amount from about 20 μg per day to about 100 μg per day of the PTH-Fc fusion protein.

7. The method of claim 1 , wherein the PTH-Fc fusion protein is glycosylated.

8. A method of increasing serum calcium levels in a subject in need thereof comprising administering to the subject an effective amount of a pharmaceutical composition comprising a PTH-Fc fusion protein, wherein the PTH-Fc fusion protein is PTH-66 having the amino acid sequence of SEQ ID NO: 8.

9. The method of claim 8 , wherein the pharmaceutical composition is administered subcutaneously.

10. The method of claim 8 , wherein the pharmaceutical composition is administered once daily.

11. The method of claim 8 , wherein the pharmaceutical composition is administered once weekly.

12. The method of claim 8 , wherein the PTH-Fc fusion protein is glycosylated.

13. A method of increasing serum calcium levels in a subject in need thereof comprising administering to the subject an effective amount of a pharmaceutical dosage form comprising a PTH-Fc fusion protein, wherein the PTH-Fc fusion protein is PTH-66 having the amino acid sequence of SEQ ID NO: 8.

14. The method of claim 13 , wherein the pharmaceutical dosage form is administered subcutaneously.

15. The method of claim 13 , wherein the pharmaceutical dosage form is administered once daily.

16. The method of claim 13 , wherein the pharmaceutical dosage form is administered once weekly.

17. The method of claim 13 , wherein the pharmaceutical dosage form is a liquid dosage form suitable for administration by injection or infusion.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 27, 2023
From: PAN, CLARK; NORTON, ANGELA; HOLMES, KEVIN; LLOYD, DAVID BRUCE; GOODWIN, BRYAN JAMES; SHI, RONGXIN; JAIN, SUJIT; SHEN, CHUAN
To: SHIRE-NPS PHARMACEUTICALS, INC.
Reel/Frame 064126/0011 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 16, 2023
From: TAKEDA PHARMACEUTICALS U.S.A., INC.
To: TAKEDA PHARMACEUTICAL COMPANY LIMITED
Reel/Frame 063977/0474 →
MERGER AND CHANGE OF NAME Recorded Mar 14, 2023
From: SHIRE-NPS PHARMACEUTICALS, INC.; TAKEDA PHARMACEUTICALS U.S.A., INC.
To: TAKEDA PHARMACEUTICALS U.S.A., INC.
Reel/Frame 062980/0041 →
Continuity (5)
Continuation 16776107 · Jan 29, 2020
Provisional Application 62884730 · Aug 9, 2019
Provisional Application 62800744 · Feb 4, 2019
Provisional Application 62798113 · Jan 29, 2019
Related Publication 20230340057A1 · Oct 26, 2023
References Cited (17)
US 6756480B2 · Kostenuik et al. · 2004 [cited by applicant]
US 9579392B2 · Culbertson · 2017 [cited by examiner]
US 11634468B2 · Pan · 2023 [cited by examiner]
US 20030039654A1 · Kostenuik et al. · 2003 [cited by applicant]
US 20030171288A1 · Stewart · 2003 [cited by applicant]
WO 2015057836 · 2015 [cited by applicant]
WO 2017067964A1 · 2017 [cited by applicant]
WO 2017148883 · 2017 [cited by applicant]
WO 2017152090 · 2017 [cited by applicant]
WO 2017218977 · 2017 [cited by applicant]
International Search Report mailed Jun. 23, 2020 in connection with PCT International Application No. PCT/US20/15634. [cited by applicant]
Written Opinion mailed Jun. 23, 2020 in connection with PCT International Application No. PCT/US20/15634. [cited by applicant]
European Search Report mailed Jun. 9, 2023 in connection with European Patent Application No. 20749256.2. [cited by applicant]
Office Action issued Oct. 17, 2023 in connection with Chinese Patent Application No. 202080014922.1. [cited by applicant]
Office Action issued in counterpart Japanese Application No. 2021-544383 dated May 15, 2024 (including English translation). [cited by applicant]
Office Action issued in counterpart Japanese Application No. 2021-544383 dated Dec. 18, 2023 (including English translation). [cited by applicant]
Hezareh et al., “Effector Function Activities of a Panel of Mutants of a Broadly Neutralizing Antibody against Human Immunodeficiency Virus Type 1”, Journal of Virology, Dec. 2001, vol. 75, No. 24, pp. 12161-12168. DOI:… [cited by applicant]