UCB and Amgen Launch Phase 3 Clinical Program for Sclerostin Antibodies to Treat Postmenopausal Osteoporosis
24.04.2012 11:36
Biopharmaceutical company UCB and biotechnology company Amgen have announced the initiation of the Phase 3 clinical program for their sclerostin antibody (CDP7851/AMG 785) for the treatment of postmenopausal osteoporosis.
The Phase 3 program involves a two-year, multicenter, international, randomized, double-blind, placebo-controlled, parallel-group study in over 5,000 postmenopausal women suffering from osteoporosis. The primary endpoint assesses the incidence of new vertebral fractures at 12 months. Initial results from the Phase 3 program are expected at the end of 2015.
CDP7851/AMG 785 is a humanized monoclonal antibody that binds and blocks sclerostin, a protein produced by bone cells that inhibits bone formation. By binding sclerostin and inhibiting it, CDP7851/AMG 785 can support the body in building bone. With over 75 million people suffering from osteoporosis worldwide, there is a strong patient need for bone-forming therapeutics. Amgen and UCB are collaborating to develop CDP7851/AMG 785 to treat bone disorders such as postmenopausal osteoporosis and fracture healing.
“We look forward to collaborating with UCB on the CDP7851/AMG 785 Phase 3 program,” said Sean E. Harper, MD, executive vice president of research and development at Amgen. “Despite existing osteoporosis therapies, there remains a significant need for additional therapeutic options that lead to new bone formation in women with postmenopausal osteoporosis.”
“Our sclerostin antibody project in collaboration with Amgen is one of the most exciting pipeline projects in UCB's portfolio. The data collected so far shows the potential for a paradigm shift in the treatment of postmenopausal osteoporosis,” says Prof. Dr. med. Iris Loew-Friedrich, UCB Chief Medical Officer and Executive Vice-President Global Projects and Development. “We are very excited about the start of the Phase 3 program. The progress made to date motivates us to develop a new treatment option for women suffering from postmenopausal osteoporosis.”