UCB and Amgen initiate sclerostin antibody Phase 3 program in patients with Postmenopausal Osteoporosis

UCB (Euronext Brussels: UCB) and Amgen (NASDAQ:AMGN) announced today the start of their sclerostin antibody (CDP7851/AMG 785) Phase 3 clinical trial program for the treatment of postmenopausal osteoporosis.

“We look forward to working with UCB on the CDP7851/AMG 785 Phase 3 program,” said Sean E. Harper, M.D., executive vice president of Research and Development 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. med. Iris Loew-Friedrich, Chief Medical Officer of UCB and Executive Vice-President Global Projects and Development. “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 women living with postmenopausal osteoporosis.”

The Phase 3 program includes a multicenter, international, 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 3 program are expected by the end of 2015.

CDP7851/AMG 785 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/AMG 785 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 are collaborating on the development of CDP7851/AMG 785 for the treatment of bone-related conditions, including postmenopausal osteoporosis and fracture healing.

About Postmenopausal Osteoporosis

Osteoporosis is the most common disorder of bone metabolism. Osteoporosis, or porous bone, is a chronic, progressive and systemic disease marked by low bone mass, deterioration of bone tissue and low bone strength, leading to bone fragility and an increased risk of fractures. The rate of bone loss is accelerated in women during and after the menopause as a result of estrogen deficiency associated with the loss of ovarian function at menopause. The risk of fracture increases exponentially with age. The prevalence of osteoporosis is estimated to be 64.6 million people in the seven major markets; women are four times more likely than men to develop osteoporosis.