Amgen (NASDAQ: AMGN) and UCB (Euronext Brussels: UCB) announced today positive top-line results from their Phase 2 clinical study comparing sclerostin-antibody AMG 785/CDP7851 to placebo in postmenopausal women with low bone mineral density (BMD) for the treatment of postmenopausal osteoporosis (PMO).
This Phase 2 study met its primary endpoint, demonstrating significant increases in lumbar spine bone mineral density at month 12 for the AMG 785/CDP7851 active arms versus the placebo arm. In addition, AMG 785/CDP7851 compared positively with the two active comparators, teriparatide and alendronate.
The overall incidence of adverse events was generally balanced between groups. Consistent with previous studies, injection site reactions were reported more frequently in those patients receiving AMG 785/CDP7851.
"We are very encouraged by the results of this study," said Roger M. Perlmutter, M.D., Ph.D., executive vice president of Research and Development 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 AMG 785/CDP7851 program into Phase 3."
"The AMG 785/CDP7851 project with Amgen is one of the most exciting pipeline programs in UCB's immunology disease portfolio. The favorable comparison with established therapies indicates the potential for a change of treatment paradigms with AMG 785/CDP7851 in PMO," said Prof. Dr. med. Iris Loew-Friedrich, chief medical officer of UCB and executive vice-president Global Projects and Development. "We will now begin the in depth analysis of the data to prepare for the Phase 3 program. The results fuel our energy working towards providing a new treatment option for the millions of women living with PMO."
The 12-month Phase 2 study is a multi-center, international, randomized, placebo-controlled, parallel-group study designed to evaluate the effect of AMG 785/CDP7851 compared to placebo in women with low BMD, and to characterize the safety and tolerability of AMG 785/CDP7851. 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.
Detailed results will be submitted for presentation at a future medical congress.
AMG 785/CDP7851 is a humanized monoclonal antibody that binds to and inhibits sclerostin, a protein secreted by bone cells that inhibits bone formation. By binding to and blocking sclerostin, AMG 785/CDP7851 is designed to allow the body to add more bone to the skeleton. Amgen and UCB have collaborated for the development of AMG 785/CDP7851 for the treatment of bone-related conditions, including PMO and fracture healing.
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