Ascendis Pharma has been granted a patent for a pharmaceutical composition that includes a parathyroid hormone (PTH) compound. The composition is suitable for subcutaneous administration and has a pharmacokinetic profile with a peak to trough ratio of less than 4 within one daily injection interval. The PTH compound is a water-soluble controlled-release PTH compound. GlobalData’s report on Ascendis Pharma gives a 360-degree view of the company including its patenting strategy. Buy the report here.
According to GlobalData’s company profile on Ascendis Pharma, Nanoparticle drug conjugates was a key innovation area identified from patents. Ascendis Pharma's grant share as of September 2023 was 36%. Grant share is based on the ratio of number of grants to total number of patents.
A recently granted patent (Publication Number: US11759504B2) discloses a pharmaceutical composition comprising a parathyroid hormone (PTH) compound. The composition is suitable for subcutaneous administration and exhibits a specific pharmacokinetic profile. After subcutaneous administration to a mammal, the PTH compound has a peak to trough ratio of free PTH of less than 4 in plasma within one daily injection interval at steady state. The PTH compound is a water-soluble controlled-release PTH compound of formula (Ia) or a pharmaceutically acceptable salt thereof.
The patent claims also specify various aspects of the pharmaceutical composition. It mentions that the subcutaneous administration is via subcutaneous injection and can be done using a pen device. The peak to trough ratio of the PTH compound is less than 3, indicating a controlled release of the compound. The administration can be to a non-human primate, specifically a cynomolgus monkey, or to a human. The pharmaceutical composition has a pH ranging from and including pH 3 to pH 8, or more specifically, ranging from and including pH 4 to pH 5. Additionally, the patent claims describe the use of a branched polyethylene glycol polymer (-Z) in the composition and specify that it may have one branching point. Furthermore, the patent claims mention the attachment of -L2-L1 to the N-terminal amine functional group of -D in the composition.
This patent provides valuable information about a pharmaceutical composition comprising a PTH compound with specific pharmacokinetic properties. The controlled-release nature of the composition allows for a peak to trough ratio of free PTH of less than 4, indicating a sustained release of the compound. The subcutaneous administration via injection, potentially using a pen device, offers a convenient and efficient method of delivery. The patent also highlights the potential use of the composition in non-human primates, specifically cynomolgus monkeys, and in humans. The specified pH range of the composition ensures its stability and compatibility with biological systems. The incorporation of a branched polyethylene glycol polymer in the composition adds to its controlled-release properties. Overall, this patent presents a novel pharmaceutical composition with potential applications in the field of PTH therapy.