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Publication Number
US-12611447-B2
Publication Date
2026-04-28
Expiration Date
Abstract
Featured are compositions and methods for treating bone mineralization disorders, such as hypophosphatasia (HPP). In some embodiments, the methods described herein are useful for treating adult subjects with HPP and/or treating or preventing bone fractures.
Core Innovation
The disclosure concerns treating a mild phenotype of hypophosphatasia (HPP) in a human subject using soluble alkaline phosphatase (sALP). The regimen includes administering at least one dose of sALP in a first treatment phase, where the sALP has at least 90% sequence identity to SEQ ID NO: 1.
During the first treatment phase, the subject is intermittently or continuously monitored for changes in at least one physical metric that identifies the subject as needing treatment for HPP. The physical metric is monitored using a wearable device, and the monitoring is used to evaluate whether improvement occurs above a predetermined threshold.
When improvement in the at least one physical metric is detected above the predetermined threshold, the method enters a first non-treatment phase in which the subject is not administered the sALP. The disclosure describes a phase-based therapy concept in which administration and non-administration phases are determined by monitored changes in the physical metric.
Claims Coverage
The provided content includes one independent claim. It comprises two inventive features: sALP treatment of mild HPP defined by sequence identity to SEQ ID NO: 1, and wearable-device monitoring of physical metrics to trigger transition from treatment to non-treatment after improvement above a predetermined threshold.
SALP treatment of mild hypophosphatasia
A method of treating a mild phenotype of hypophosphatasia (HPP) in a human subject by administering at least one dose of a soluble alkaline phosphatase (sALP) having at least 90% sequence identity to SEQ ID NO: 1 in a first treatment phase.
Wearable-device monitoring and threshold-based non-treatment phase
Intermittently or continuously monitoring the subject during the first treatment phase for changes in at least one physical metric using a wearable device, detecting improvement above a predetermined threshold, and entering a first non-treatment phase during which the subject is not administered the sALP.
Overall, the claim coverage centers on a mild-HPP sALP regimen that uses wearable-device monitoring of physical metrics to determine when treatment stops by entering a non-treatment phase after improvement above a predetermined threshold.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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