Claims for Patent: 11,590,207

Summary for Patent: 11,590,207

Title:	Dosage regimen for a controlled-release PTH compound
Abstract:	The present invention relates to a pharmaceutical composition comprising at least one controlled-release PTH compound or a pharmaceutically acceptable salt, hydrate or solvate thereof, for use in the treatment, control, delay or prevention of a condition that can be treated, controlled, delayed or prevented with PTH, pharmaceutical composition comprising at least one controlled-release PTH compound or a pharmaceutically acceptable salt, hydrate or solvate thereof, for use in the treatment, control, delay or prevention of a condition that can be treated, controlled, delayed or prevented with PTH, wherein said 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 70% of the molar equivalent dose of PTH 1-84 administered every 24 hours required to maintain serum calcium within normal levels over said 24 hour period in humans.
Inventor(s):	Lars Holten-Andersen, Kennett Sprogøe, David Brian Karpf
Assignee:	Ascendis Pharma Bone Diseases AS
Application Number:	US16/337,713
Patent Claims:	1. A method of treating or controlling hypoparathyroidism in a mammalian patient, comprising the step of administering a pharmaceutical composition comprising at least one controlled-release parathyroid hormone (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 20-40% of the molar equivalent dose of PTH 1-84 administered subcutaneously every 24 hours, which is required to maintain a serum albumin-adjusted calcium level in serum of above 8.5 mg/dL over a 24 hour period in humans and wherein the controlled release PTH compound is of formula: wherein the unmarked dashed line indicates the attachment to an 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 ranging from and including 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 has a pH ranging from and including pH 3 to pH 8. 4. The method of claim 1, wherein the mammalian patient is a human patient. 5. The method of claim 1, wherein the dosage of the controlled-release PTH compound corresponds to no more than 30% of the molar equivalent dose of PTH 1-84.