Claims for Patent: 12,295,989

Summary for Patent: 12,295,989

Title:	Controlled-release PTH compound
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.
Inventor(s):	Kennett Sprogøe, Guillaume Maitro, Mathias Krusch, Thomas Wegge, Joachim Zettler, Lars Holten-Andersen, David Brian Karpf
Assignee:	Ascendis Pharma Bone Diseases AS
Application Number:	US18/421,786
Patent Claims:	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.