Amgen, Inc. (NASDAQ:AMGN) disclosed today that its Phase III study in postmenopausal women with osteoporosis met all primary endpoints. The company indicated that the new drug romosozumab deceased new vertebral fracture incidence. The late-stage trial also met one secondary endpoint of reducing clinical fracture incidence as well. However, one setback was that its non-vertebral fractures incidence reduction for 12 and 24 months failed to meet the secondary endpoint.
Amgen developed the study together with UC Berkeley, billed Fracture Study in Postmenopausal Women With Osteoporosis (FRAME). The study results indicated that women who were administered subcutaneous romosozumab injections on a monthly basis witnessed a significant 73% reduction in the relative risk through a 12-month period compared to those getting placebo.
The study results suggested that for the full 24 months, romosozumab followed denosumab in reducing the relative risk of fresh vertebral fracture by 75% compared with placebo. Patients getting romosozumab witnessed a 36% reduction in the comparable risk of a clinical fracture throughout the 12-month period compared to placebo.
Amgen’s Executive VP of R&D Sean Harper pointed out that a vertebral fracture could be a life changing event due to osteoporosis. He also said that this kind of risk of fractures would be a growing problem as US society ages. Harper said that the data demonstrated that romosozumab was able to reduce the fresh vertebral fracture risk to a 12-month period.
Amgen said that additional analysis of its late-stage trial on FRAME was ongoing and that the results would be submitted to an upcoming medical conference for publication. The companies believe that a deeper understanding would allow them to sharpen the romosozumab profile. The company expects a potential filing this year and intends to discuss the results with international regulators.