Claims for Patent: 11,890,326

Summary for Patent: 11,890,326

Title:	Controlled-release PTH compound
Abstract:	The present invention relates to a controlled-release parathyroid hormone (PTH) compound in which PTH(1-34) is reversibly conjugated to a branched polyethylene glycol. The invention further relates to a pharmaceutical composition of the compound. The compound or pharmaceutical composition is useful for treatment, control, delay or prevention of a condition that can be treated, controlled, delayed or prevented with PTH.
Inventor(s):	Kennett Sprogøe, Felix Cleemann, Guillaume Maitro, Mathias Krusch, Thomas Wegge, Joachim Zettler
Assignee:	Ascendis Pharma Bone Diseases AS
Application Number:	US18/063,294
Patent Claims:	1. A parathyroid hormone (PTH) conjugate of formula: or a pharmaceutically acceptable salt thereof, wherein the unmarked dashed line indicates the attachment by an amide bond to the N-terminal nitrogen of a PTH moiety, the amino acid sequence of which consists of the sequence of SEQ ID NO:51; and the dashed line marked with the asterisk indicates attachment to a moiety wherein m and p are independently an integer ranging from and including 400 to 500. 2. The PTH conjugate or pharmacologically acceptable salt thereof of claim 1, wherein the moiety has a molecular weight of about 40 kDa. 3. The PTH conjugate or pharmacologically acceptable salt thereof of claim 1, wherein m and p are the same integer. 4. The PTH conjugate or a pharmacologically acceptable salt thereof of claim 1, wherein m and p are about 450. 5. A pharmaceutical composition comprising the PTH conjugate or pharmaceutically acceptable salt thereof of claim 1 and at least one excipient. 6. The pharmaceutical composition of claim 5, wherein the pharmaceutical composition has a pH of 4-6. 7. A liquid pharmaceutical composition comprising a parathyroid hormone (PTH) conjugate of formula: or a pharmaceutically acceptable salt thereof, and a solvent, wherein the unmarked dashed line indicates the attachment by an amide bond to the N-terminal nitrogen of a PTH moiety, the amino acid sequence of which consists of the sequence of SEQ ID NO:51; and the dashed line marked with the asterisk indicates attachment to a moiety wherein m and p are independently an integer ranging from and including 400 to 500. 8. The liquid pharmaceutical composition of claim 7, wherein the moiety has a molecular weight of about 40 kDa. 9. The liquid pharmaceutical composition of claim 7, wherein m and p are the same integer. 10. The liquid pharmaceutical composition of claim 7, wherein m and p are about 450. 11. The liquid pharmaceutical composition of claim 7, wherein the solvent is water.