Pharmaceutical major Aurobindo Pharma Ltd, on 10 April, announced that its subsidiary, CuraTeQ Biologics, has successfully completed the phase 1 Trial of its new bone treatment medicine, BP16. 

The new medicine, BP16, was tested on 204 health volunteers and compared with Prolia, which is the original drug that is being sold in the United States and Europe. 

The drug functions by inhibiting a protein called RANKL, which is responsible for the breakdown of bone tissue. This mechanism makes it effective in treating:

• Osteoporosis in postmenopausal women
• Bone complications resulting from cancer spreading to the bones
• Bone weakening due to cancer treatments

The Phase 1 study involved 204 participants from Australia and New Zealand and successfully achieved all of its primary endpoints. The successful completion of the trial is an important step toward introducing a more affordable version of this medication to patients. 

According to CuraTeQ Biologics, the study demonstrated that BP16 closely replicates the pharmacokinetic (PK) profile of the reference drugs. It met key bioequivalence standards, such as peak serum concentration and total drug exposure, falling within the accepted range of 80–125%.

The company also reported that BP16 showed similar pharmacodynamic behaviour, safety profile, and immune response when compared to both the EU and US reference versions. 

Dr Disha Dadke, Head of R&D and Regulatory Sciences at CuraTeQ Biologics, said that the company is also very confident in its ongoing Phase 3 trial, which is currently underway across multiple locations in the EU. This study focuses on postmenopausal women with osteoporosis and is expected to conclude by May or June 2025.

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