Claims for Patent: 11,857,603

Summary for Patent: 11,857,603

Title:	PTH compounds with low peak-to-trough ratios
Abstract:	The present invention relates to a pharmaceutical composition comprising a PTH compound, wherein after subcutaneous administration the pharmacokinetic profile of the PTH compound exhibits a peak to trough ratio of less than 4 within one injection interval.
Inventor(s):	Kennett Sprogøe, Lars Holten-Andersen, David Brian Karpf, Felix Cleemann, Guillaume Maitro, Mathias Krusch, Thomas Wegge, Joachim Zettler
Assignee:	Ascendis Pharma Bone Diseases AS
Application Number:	US18/053,701
Patent Claims:	1. A method of treating a human patient having hypoparathyroidism comprising subcutaneously administering to the subject a PTH compound, wherein the pharmacokinetic profile of the PTH compound exhibits a peak to trough ratio of less than 4 within one administration interval at a steady state, wherein the PTH compound is a water-soluble controlled-release PTH compound of formula (Ia) or a pharmaceutically acceptable salt thereof: wherein -D is a PTH moiety, which has the sequence of SEQ ID NO: 51; -L2-L1- has the formula: wherein the unmarked dashed line indicates the attachment to a nitrogen of -D by an amide bond; and the dashed line marked with an asterisk indicates attachment to —Z; x is 1; —Z comprises a moiety of formula (b): wherein the dashed line indicates attachment to -L2 and m and p are independently of each other an integer ranging from 150-1000; and the PTH moiety is released with a release half-life of at least 12 hours. 2. The method composition of claim 1, wherein the administration interval is at least 24 hours. 3. The method of claim 1, wherein the administration interval is 24 hours. 4. The method of claim 1, wherein the administration interval is one week. 5. The method of claim 1, wherein the subcutaneous administration is via subcutaneous injection. 6. The method of claim 1, wherein the subcutaneous administration occurs with a pen device. 7. The method of claim 1, wherein the peak to trough ratio is less than 3. 8. The method of claim 1, wherein the PTH compound is administered as a pharmaceutical composition having a pH ranging from and including pH 3 to pH 8. 9. The method of claim 8, wherein the pharmaceutical composition has a pH ranging from and including pH 4 to pH 5. 10. The method of claim 1, wherein m and p are independently of each other an integer ranging from 400 to 500. 11. The method of claim 10, wherein -L2-L1 is attached to the N-terminal amine functional group of -D. 12. The method of claim 1, wherein -L2-L1 is attached to the N-terminal amine functional group of -D.