Belgium’s UCB and Amgen have started the sclerostin antibody (CDP7851/AMG 785) Phase 3 clinical trial programme for the treatment of postmenopausal osteoporosis.
CDP7851/AMG 785 is a humanised monoclonal antibody that binds to and inhibits sclerostin, a protein secreted by bone cells that inhibits bone formation.
The Phase 3 programme includes a multicentre, international, randomised, double-blind, placebo-controlled, parallel-group, two-year study in more than 5,000 postmenopausal women with osteoporosis, and was designed to investigate the incidence of new vertebral fractures at 12 months.
Amgen research and development executive vice president Sean Harper said despite available osteoporosis therapies, there remains a need for additional treatment options that form new bone in women diagnosed with postmenopausal osteoporosis.
UCB chief medical officer and global projects and development executive vice-president Iris Loew-Friedrich said data collected to date indicate the potential for a change of treatment paradigms in postmenopausal osteoporosis.
“The progress made to date encourages and motivates us as we work toward providing a new treatment option for women living with postmenopausal osteoporosis,” Loew-Friedrich added.
Initial results from the Phase 3 programme are likely to be reported by the end of 2015.
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.
UCB is focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. Amgen discovers, develops, manufactures, and delivers human therapeutics against cancer, kidney disease, rheumatoid arthritis, bone disease, and other serious illnesses.