IP Library › Granted Patent US 12,295,989
Granted Patent B2
US 12,295,989 · App. 18/421,786 · Granted May 13, 2025

Controlled-release PTH compound

Inventors: Kennett Sprogøe (Holte, DK); Guillaume Maitro (Mannheim, DE); Mathias Krusch (Hirschhorn, DE); Thomas Wegge (Heidelberg, DE); Joachim Zettler (Heidelberg, DE); Lars Holten-Andersen (Vanløse, DK); David Brian Karpf (Mountain View, CA)
Assignee: ASCENDIS PHARMA BONE DISEASES A/S
A61K38/29A61K9/0019A61K9/1647A61K47/54A61K47/545A61K47/60A61K47/34
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Quick Facts
Patent No.
US 12,295,989
App. No.
18/421,786
Granted
May 13, 2025
Kind
B2
Abstract

The invention provides a method of treating or controlling hypoparathyroidism in a human patient by administering to the human patient a pharmaceutical composition comprising a controlled-release PTH compound or a pharmaceutically acceptable salt thereof. The controlled-release PTH compound comprises a PTH moiety reversibly conjugated to a branched polyethylene glycol carrier. The composition is administered by subcutaneous injection no more frequently than once every 24 hours with a dosage of the controlled-release PTH compound that corresponds to no more than 70% of the molar equivalent dose of PTH 1-84 administered by subcutaneous injection at the same dosing frequency required to maintain a serum albumin-adjusted calcium level in serum of above 8.5 mg/dL over a 24 hour period.

Claims (10)

1. A method of treating or controlling hypoparathyroidism in a human patient, comprising the step of administering to the human patient a pharmaceutical composition comprising at least one controlled-release PTH compound or a pharmaceutically acceptable salt thereof by subcutaneous injection no more frequently than once every 24 hours with a dosage of the controlled-release PTH compound that corresponds to no more than 70% of the molar equivalent dose of PTH 1-84 administered by subcutaneous injection at the same dosing frequency required to maintain a serum albumin-adjusted calcium level in serum of above 8.5 mg/dL over a 24 hour period and wherein the controlled-release PTH compound is of formula:

wherein

the unmarked dashed line indicates the attachment to the N-terminal amine group of -D, which is a PTH moiety having the amino sequence of SEQ ID NO:51, by an amide bond; and

the dashed line marked with the asterisk indicates attachment to a moiety

wherein

each of m and p is independently an integer from 400 to 500.

2. The method of claim 1 , wherein the pharmaceutical composition is administered once every 24 hours.

3. The method of claim 1 , wherein the pharmaceutical composition is administered with a pen injector.

4. The method of claim 1 , wherein the pharmaceutical composition is administered no more frequently than once every 24 hours with a dosage of the controlled-release PTH compound that corresponds to no more than 60% of the molar equivalent dose of PTH 1-84 administered by subcutaneous injection at the same dosing frequency required to maintain the serum albumin-adjusted calcium level in serum of above 8.5 mg/dL over a 24 hour period.

5. The method of claim 1 , wherein the pharmaceutical composition has a pH ranging from and including pH 3 to pH 8.

Priority Claims (2)
EP 16191451 · Sep 29, 2016 · regional
EP 17155843 · Feb 13, 2017 · regional
Continuity (4)
Continuation 18355223 · Jul 19, 2023
Continuation 18063294 · Dec 8, 2022
Continuation 16337713
Related Publication 20240245755A1 · Jul 25, 2024
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