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news.Amgen and UCB's 12-month Phase 2 multi-center, international, randomized, placebo-controlled 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) met primary endpoint.
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The study results showed increase in lumbar spine bone mineral density at month 12 for the AMG 785/CDP7851 active arms versus the placebo arm.
The study was planned to investigate the effect of AMG 785/CDP7851 as compare to placebo in women with low BMD, and to find out the safety and tolerability of AMG 785/CDP7851.
Both companies are now planning to start the in depth analysis of the data to prepare for the Phase 3 program.
Amgen Research and Development executive vice president Roger Perlmutter said they look forward to working with UCB to advance the AMG 785/CDP7851 program into Phase 3.
UCB chief medical officer Iris Loew-Friedrich said the favorable comparison with established therapies indicates the potential for a change of treatment paradigms with AMG 785/CDP7851 in PMO.