UCB and Amgen’s osteoporosis drug shows promise
pharmafile | April 21, 2011 | News story | Research and Development |Â Â Amgen, UCB, osteoporosisÂ
Amgen and UCB have announced strong results from a phase II study of their new postmenopausal osteoporosis treatment.
Most existing treatments only prevent further bone loss, but CDP7851/AMG785 has been shown to promote re-growth of bones in postmenopausal women with the condition.
The trial also studied the drug in comparison with Forteo (teriparatide) and Fosamax (alendronate), two of the current standard treatments in the market.
Analysts Jeffries International say the drug could be a blockbuster. Results from two further phase II trials, which will look at how well the drug can help fractures to heal, are due next year.
Top line results show CDP7851/AMG785 met its primary endpoint, demonstrating significant increases in lumbar spine bone mineral density (BMD) after 12 months of treatment compared to a placebo arm.
Adverse events were generally balanced between groups, and the greater incidence of injection site reactions in patients receiving CDP7851/AMG785 was as predicted.
“We are encouraged by the results of this study,” said Dr Roger Perlmutter, head of R&D at Amgen. “Despite available osteoporosis therapies, there remains a significant need for additional treatment options that form new bone in women with postmenopausal osteoporosis. We look forward to working with UCB to advance the CDP7851/AMG785 programme into phase III.”
CDP7851/AMG785 is a humanised monoclonal antibody that binds to and inhibits sclerostin, a protein secreted by bone cells that inhibits bone formation. In this way the drug is designed to allow the body to add more bone to the skeleton. The two companies are developing CDP7851/AMG785 for a range of bone problems of bone-related, including postmenopausal osteoporosis and fracture healing.
“The CDP7851/AMG785 project with Amgen is one of the most exciting pipeline programmes in UCB’s immunology disease portfolio. The favourable comparison with established therapies indicates the potential for a change of treatment paradigms with CDP7851/AMG785 in PMO”, said Prof Iris Loew-Friedrich, chief medical officer of UCB and head of global projects and development.
Approximately 400 postmenopausal women with low BMD (T-scores between -2.0 and -3.5) are enrolled in the study. Treatment arms included dosing at 70, 140 and 210 mg subcutaneously once a month, and 140 and 210 mg every three months, against matched placebo for all treatment groups.
The developers will now conduct an in depth analysis of the data to prepare for the phase III programme and detailed results will be submitted for presentation at a future medical congress.
Andrew McConaghie
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