US 12,295,989 B2
Controlled-release PTH compound
Kennett Sprogøe, Holte (DK); Guillaume Maitro, Mannheim (DE); Mathias Krusch, Hirschhorn (DE); Thomas Wegge, Heidelberg (DE); Joachim Zettler, Heidelberg (DE); Lars Holten-Andersen, Vanløse (DK); and David Brian Karpf, Mountain View, CA (US)
Assigned to ASCENDIS PHARMA BONE DISEASES A/S, Hellerup (DK)
Filed by ASCENDIS PHARMA BONE DISEASES A/S, Hellerup (DK)
Filed on Jan. 24, 2024, as Appl. No. 18/421,786.
Application 18/421,786 is a continuation of application No. 18/355,223, filed on Jul. 19, 2023, granted, now 11,918,628.
Application 18/355,223 is a continuation of application No. 18/063,294, filed on Dec. 8, 2022, granted, now 11,890,326, issued on Feb. 6, 2024.
Application 18/063,294 is a continuation of application No. 16/337,713, granted, now 11,590,207, issued on Feb. 28, 2023, previously published as PCT/EP2017/074592, filed on Sep. 28, 2017.
Claims priority of application No. 16191451 (EP), filed on Sep. 29, 2016; and application No. 17155843 (EP), filed on Feb. 13, 2017.
Prior Publication US 2024/0245755 A1, Jul. 25, 2024
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 38/29 (2006.01); A61K 9/00 (2006.01); A61K 9/16 (2006.01); A61K 47/54 (2017.01); A61K 47/60 (2017.01); A61K 47/34 (2017.01)
CPC A61K 38/29 (2013.01) [A61K 9/0019 (2013.01); A61K 9/1647 (2013.01); A61K 47/54 (2017.08); A61K 47/545 (2017.08); A61K 47/60 (2017.08); A61K 47/34 (2013.01)] 5 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:

OG Complex Work Unit Chemistry
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

OG Complex Work Unit Chemistry
wherein
each of m and p is independently an integer from 400 to 500.