(MENAFN- ProactiveInvestors - Australia) Bone Medical (ASX: BNE) has completed the patient dosing phase of a clinical trial being carried out for the company's oral CaPTHymoneâ„¢ drug for the treatment of osteoporosis.
The company considers the drug its lead candidate in its portfolio, reflecting its clinical stage status, potentially short, low-risk development pathway, and significant market opportunity.
Conducted under a clinical trial agreement with Brisbane-based Q-Pharm, the study began patient dosing late in the December quarter 2012.
This study will provide a robust clinical benchmark for the product compared to injectable parathyroid hormone (PTH), the only form of this medicine that is currently available.
Injectable PTH is a major treatment alternative for osteoporosis that despite being limited by the lack of a convenient oral form that can be taken by mouth achieved $1 billion in global sales in 2011.
Bone Medical's clinical studies to date suggest that CaPTHymoneâ„¢ could become an effective oral alternative to injectable PTH.
The trial currently underway uses a cross-over design in which each patient receives one of two alternative strengths of the oral CaPTHymoneâ„¢, injectable PTH, or placebo at different times, an approach that allows each patient to act as their own control.
The study will compare the blood levels of PTH achieved by each treatment to determine whether Bone Medical's oral formulation can achieve a pharmacokinetic profile similar to that of the injectable product.
If successful, CaPTHymoneâ„¢ could become the first and potentially the only oral form of this therapy, substantially expanding its clinical utility.
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