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.
Amgen discovers, develops, manufactures, and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe, effective medicines from lab to manufacturing plant to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, bone disease, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. To learn more about our pioneering science and vital medicines, visit www.amgen.com.
UCB, Brussels, Belgium (www.ucb.co
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