Bone-Forming Agent Shows Promise

Romosozumab, a bone-forming agent currently under study by Amgen, Inc. and Belgium’s UCB, has shown promise in several new analyses. The work, which concentrates on evaluating the drug’s efficacy in postmenopausal women with low bone mineral density (BMD), found that romosozumab led to increases in lumbar spine and total hip BMD. The mechanism of action with romosozumab is such that it inhibits the protein sclerostin, thereby increasing bone formation and decreasing bone breakdown.

“Fractures or broken bones due to osteoporosis are very common and often have a life altering impact on an older woman and her family, ” said Michael McClung, M.D., director of the Oregon Osteoporosis Center, in the September 15, 2014 news release. “It is encouraging to see that treatment with romosozumab for a second year provided additional increases in bone mineral density beyond what was seen during the first 12 months of treatment.”

Dr. McClung told OTW, “Romosozumab, an anti-sclerostin antibody being developed as a treatment for postmenopausal osteoporosis, leads to substantial and continued BMD increases over two years through an increase in bone formation and a simultaneous reduction in bone resorption. The effects of romosozumab on bone mineral density and markers of bone remodeling disappear within one year of stopping therapy. The effects on BMD are further augmented by follow-on therapy with a potent anti-remodeling drug like denosumab. Also, romosozumab therapy is well-tolerated over a two year period.”

He added, “Romosozumab is currently being evaluated in Phase 3 studies as a one year treatment followed by anti-remodeling therapy. The results of those studies will inform us of the ability of romosozumab to protect postmenopausal women with osteoporosis from fractures.”

“We are very excited about the potential of romosozumab to significantly build bone for people at high risk for fracture, in particular those who have already fractured, given the impact this can have on a patient, ” said Sean E. Harper, M.D., Amgen’s executive vice president of Research and Development in the news release. “We look forward to continued investigation of romosozumab in our extensive global Phase 3 program, which includes two large fracture trials comparing the treatment to either placebo or active comparators in more than 10, 000 patients with osteoporosis.”