Granted Patent B2

US 12,453,778 · App. 16/337,803 · Granted Oct 28, 2025

Inventors: David Brian Karpf (Mountain View, CA); Kennett Sprogøe (Holte, DK); Lars Holten-Andersen (Vanløse, DK); Felix Cleemann (Mainz, DE); Guillaume Maitro (Mannheim, DE); Mathias Krusch (Hirschhorn, DE); Thomas Wegge (Heidelberg, DE); Joachim Zettler (Heidelberg, DE)

Assignee: ASCENDIS PHARMA BONE DISEASES A/S

A61K47/593A61K9/0019A61K38/29A61K47/10A61K47/18A61K47/22A61K47/60A61P5/18

Abstract

Claims (16)

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-(L 2 -L 1 -D) x   (Ia);

wherein —Z comprises a branched PEG polymer with a molecular weight of about 40 kDa,

-L 2 -L 1 - 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 -L 2 - 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 -L 2 -L 1 - is attached by an amide bond to the N-terminal amine functional group of -D.

Assignments (5)

Priority Claims (1)

Continuity (1)

References Cited (285)