UCB and Amgen have announced the start of a Phase III clinical trial programme for their sclerostin antibody for the treatment of postmenopausal osteoporosis.
The programme includes a two-year study in more than 5,000 postmenopausal women with osteoporosis and its primary endpoint will evaluate the incidence of new vertebral fractures at 12 months. Initial results are expected by the end of 2015.
The investigational monoclonal antibody binds to and inhibits sclerostin, a protein secreted by bone cells that inhibits bone formation. As such, the drug, known as CDP7851/AMG 785 is designed to increase the amount of bone in the skeleton.
Iris Loew-Friedrich, R&D chief at the Belgian drugmaker, said that “our sclerostin antibody project with Amgen is one of the most exciting pipeline programmes in UCB’s portfolio”. She added that data collected so far “indicate the potential for a change of treatment paradigms in postmenopausal osteoporosis”.
Sean Harper, head of R&D at Amgen, added that “despite available osteoporosis therapies, there remains a significant need for additional treatment options that form new bone in women diagnosed with postmenopausal osteoporosis.”
