UCB, a global biopharmaceutical based in Brussels, Belgium, and biotech Amgen have initiated their sclerostin antibody (CDP7851/AMG785) phase III clinical trial program for the treatment of postmenopausal osteoporosis.
The international phase III program of CDP7851/AMG785 includes a multicenter, randomized, double-blind, placebo-controlled, parallel-group, two-year study in more than 5,000 postmenopausal women with osteoporosis. The primary endpoint will evaluate the incidence of new vertebral fractures at 12 months. Initial results from the phase III program are expected by the end of 2015.
The study compound, CDP7851/AMG785, 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, CDP7851/AMG785 is designed to increase the amount of bone in the skeleton. With more than 75 million people worldwide suffering from osteoporosis, there is a serious patient need for therapeutics that help build bone. Amgen and UCB hope to use the compound for the treatment of postmenopausal osteoporosis and fracture healing.
"Our sclerostin antibody project with Amgen is one of the most exciting pipeline programs in UCB's portfolio,” said Iris Loew-Friedrich, PhD, chief medical officer and executive vice president of global projects and development, UCB. “Data collected so far indicate the potential for a change of treatment paradigms in postmenopausal osteoporosis.”