Claims for Patent: 12,453,778

Summary for Patent: 12,453,778

Title:	Incremental dose finding in controlled-release PTH compounds
Abstract:	The present invention relates to pharmaceutical compositions comprising a controlled-release PTH compound or a pharmaceutically acceptable salt, hydrate, or solvate thereof, for use in a method of treating, controlling, delaying or preventing a condition which can be treated, controlled, delayed or prevented with PTH, wherein the pharmaceutical composition comprising the controlled-release PTH compound is administered in accordance with a dosage regimen in which dose adjustment in response to hypocalcemia or hypercalcemia is performed in increments of no more than 25%.
Inventor(s):	David Brian Karpf, Kennett Sprogøe, Lars Holten-Andersen, Felix Cleemann, Guillaume Maitro, Mathias Krusch, Thomas Wegge, Joachim Zettler
Assignee:	Ascendis Pharma Bone Diseases AS
Application Number:	US16/337,803
Patent Claims:	1. A method of treating a patient having hypoparathyroidism, with parathyroid hormone (PTH), wherein the method comprises the step of administering a pharmaceutical composition comprising a controlled-release PTH compound to the patient in accordance with a dosage regimen in which dose adjustment in response to hypocalcemia or hypercalcemia is performed in increments of no more than 25%; wherein the controlled-release PTH compound is of formula (Ia) or a pharmaceutically acceptable salt thereof: Z-(L2-L1-D)x (Ia); wherein —Z comprises a branched PEG polymer with a molecular weight of about 40 kDa, -L2-L1- has the formula: wherein the unmarked dashed line indicates attachment by an amide bond to a nitrogen of -D, and the dashed line marked with an asterisk indicates attachment to —Z, wherein -D is PTH (1-34) (SEQ ID NO: 51) and x is 1. 2. The method of claim 1, wherein the pharmaceutical composition is administered to the patient no more frequently than once every 24 hours. 3. The method of claim 1, wherein the pharmaceutical composition is administered to the patient once every 24 hours. 4. The method of claim 1, wherein the pharmaceutical composition is administered to the patient via subcutaneous administration. 5. The method of claim 1, wherein the pharmaceutical composition is administered to the patient once every 48 hours. 6. The method of claim 1, wherein the pharmaceutical composition is administered to the patient once every week. 7. The method of claim 1, wherein-Z comprises a moiety of formula (b): wherein the dashed line indicates attachment to -L2- or to the remainder of —Z; and m and p are independently of each other an integer ranging from and including 400 to 500. 8. The method of claim 7, wherein -L2-L1- is attached by an amide bond to the N-terminal amine functional group of -D.