Bone Medical Ltd announced today the completion of a Phase I trial of its oral parathyroid hormone (PTH) product Perthoxal™ under development for the treatment of osteoporosis.
The trial involving 18 post-menopausal women was conducted at the Clinical Trials Centre at St Vincent’s Hospital in Sydney. The final report is expected to be completed by October.
The primary aim of the study is to assess the safety and tolerability of Perthoxal™ oral PTH in two different formulations. A secondary aim is to determine whether Perthoxal™ oral PTH has the desired result of increasing the concentration of calcium in the bloodstream and the levels of PTH in the blood.
Each participant received a placebo and two of the possible three PTH forms – two Perthoxal test formulations and Eli Lilly’s FORTEO®, an injectable dosage form of PTH as a positive control. For each subject, blood samples were taken over a 10-hour post-treatment period for the subsequent measurement of calcium, PTH and a biological marker of bone turnover.
“Our goal is to develop a patient-friendly dosage form of PTH treatment which could replace an injectable product that requires daily dosing. We believe that Perthoxal™ as an oral capsule could compete directly with injectable forms of PTH and also has the potential to compete with or be complimentary to the US$4 billion bisphosphonate market,” said Michael Redman, Chief Executive Officer of Bone Medical.
Perthoxal™ oral calcitonin is the second product in Bone Medical’s portfolio to commence human clinical testing, following a successful first-in-human study using Capsitonin™ oral calcitonin last year.
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