Osteoporosis affects more than 75 million people, with women being four times more at risk of developing the disease than men. Osteoporosis is a chronic, progressive and systemic disease, whereby the bone tissue deteriorates, losing mass and strength, which makes the bones more fragile and increases the risk of fractures. Due to estrogen deficiency, the disease accelerates during and after women’s menopause as ovarian function decreases during menopause, whilst the risk of fracture progressively increases with age.

A phase 3 clinical trial program of the sclerostin antibody (CDP7851/AMG 785) for the treatment of postmenopausal osteoporosis (PMO) has just been announced by UCB and Amgen.

CDP7851/AMG 785 is a humanized monoclonal antibody, which binds to sclerostin and inhibits it. Sclerostin is a protein secreted by bone cells, which inhibits bone formation. By binding to and blocking sclerostin, the antibody is designed to increase the amount of bone in the skeleton. There is a serious need to design an appropriate therapy in the fight against osteoporosis due to the vast worldwide prevalence of the disease, and Amgen and UCB are collaborating to develop CDP7851/AMG 785 for the treatment of bone-related conditions, including PMO and fracture healing.

Sean Harper, M.D., executive vice president of Research and Development at Amgen declared:

“We look forward to working with UCB on the CDP7851/AMG 785 Phase 3 program. Despite available osteoporosis therapies, there remains a significant need for additional treatment options that form new bone in women diagnosed with postmenopausal osteoporosis.”

Prof. Dr. med. Iris Loew-Friedrich, Chief Medical Officer of UCB and Executive Vice-President Global Projects and Development added:

“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 PMO. We are delighted about the start of the phase 3 program. The progress made to date encourages and motivates us as we work toward providing a new treatment option for the millions of women living with postmenopausal osteoporosis.”

The Phase 3 trial will be conducted as a multi center, international, randomized, double blind, placebo-controlled, parallel-group, two-year study that will involve over 5,000 postmenopausal women with osteoporosis. The study’s primary endpoint has been determined to establish the number of incidence of new vertebral fractures at 12 months. First results of the phase 3 trial can be expected by the end of 2015.

Petra Rattue