THOUSAND OAKS (dpa-AFX) - Amgen (AMGN) and UCB on Monday announced positive results from several exploratory analyses of the Phase 2 study evaluating romosozumab in postmenopausal women with low bone mineral density ('BMD'). Romosozumab is an investigational bone-forming agent that is designed to work by inhibiting the protein sclerostin, thereby increasing bone formation and decreasing bone breakdown.
The data were presented at the American Society for Bone and Mineral Research (ASBMR) 2014 Annual Meeting in Houston.
Results from one analysis showed that treatment with romosozumab led to significant increases in lumbar spine and total hip BMD during the first 12 months, with continued increases through year two. After year two, patients transitioned to either treatment with Prolia (denosumab) for 12 months, which led to further BMD increases, or to placebo, in which case BMD decreased towards initial baseline.
An additional analysis of the Phase 2 study found that women treated with romosozumab had greater improvements in cortical parameters of the vertebrae, including thickness and mass, compared with those taking open-label Forteo (teriparatide) or placebo at 12 months.
In the Phase 2 study, after 12 months of treatment with romosozumab adverse events were similar across groups, except for mild, generally non-recurring injection site reactions observed more frequently with romosozumab compared with placebo. The most frequent adverse events included nasopharyngitis and arthralgia.
The companies look forward to reporting the results of the romosozumab Phase 3 program in 2016.
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