UCB, Amgen Advance Sclerostin Program

UCB and Amgen initiated their sclerostin antibody (CDP7851/AMG 785) Phase III program for the treatment of postmenopausal osteoporosis. The program includes a multicenter, randomized, double-blind, placebo-controlled study in more than 5,000 postmenopausal women with osteoporosis. The primary endpoint will evaluate the incidence of new vertebral fractures at 12 months. CDP7851/AMG 785 is a humanized monoclonal antibody that binds to and inhibits sclerostin, a protein secreted by bone cells that inhibits bone formation.

“We look forward to working with UCB on the CDP7851/AMG 785 Phase III program,” said Sean E. Harper, M.D., executive vice president of R&D at Amgen. “Despite available osteoporosis therapies, there remains a significant need for additional treatment options that form new bone in women diagnosed with postmenopausal osteoporosis.”

“Our sclerostin antibody project with Amgen is one of the most exciting pipeline programs in UCB’s portfolio. Data collected so far indicate the potential for a change of treatment paradigms in postmenopausal osteoporosis,” said Prof. Dr. Iris Loew-Friedrich, chief medical officer of UCB and executive vice president of Global Projects and Development. “We are delighted about the start of the Phase III program. The progress made to date encourages and motivates us as we work toward providing a new treatment option for women living with postmenopausal osteoporosis.”