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Amgen and UCB’s Romosozumab Meets Primary and Secondary Endpoints In Phase 3 Study for Male Osteoporosis

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Amgen and UCB have reported and announced positive results for romosozumab. These results were achieved after the Phase III placeBo contRolled study evaluatIng the efficiency anD safety of romosozumab in treatinG mEn with osteoporosis (BRIDGE).

Romosozumab is a humanized monoclonal antibody used for the treatment of osteoporosis by targeting sclerostin (a human protein encoded by the SOST gene ).

Now owned by UCB, romosozumab was first discovered by Celltech (was a leading British-based biotechnology) which entered into partnership with Amgen in 2002 for the research and development of the product and later acquired by UCB in 2004. 

In Phase I, the drug was well tolerated and increased bone density in the hip and the spine of healthy men and postmenopausal women. In Phase II, the drug increased the bone density more than biphosphate and tripartite treatment. The Phase III study was started in January 2014.

The BRIDE study met the primary endpoint of demonstrating a significant increase in the bone mineral density (BMD) at the lumbar spine in men with osteoporosis. The secondary endpoints were also reported to have been met. Secondary endpoints included the comparison of romosozumab and placebo;  the patients taking the drug experienced an increase in the BMD at the femoral neck and a total hip at 12 months and the lumbar spine, femoral neck and total hip at 6 months.

While the focus of managing osteoporosis is often on women, osteoporosis in men is also a serious health issue that poses a significant health risk to millions of men worldwide,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen.

“We are excited that these data showed romosozumab stimulates bone formation, leading to increases in bone mass, in this often overlooked and undertreated patient population.”1

The patient incidence of positively adjudicated cardiovascular (CV) SAEs was 4.9 percent (8/163) in the romosozumab group and 2.5 percent (2/81) in the placebo group, while that of positively adjudicated cardiovascular death was 0.6 percent (1/163) versus 1.2 percent (1/81), respectively.

Iris Loew-Friedrich, UCB’s chief medical officer, said: “One in three women and one in five men over the age of 50 will experience an osteoporosis-related fracture in their lives“.

“These positive results from BRIDGE add to our growing body of phase III data demonstrating romosozumab’s potential to build bone strength and to decrease fracture risk and thus help fill an unmet need for patients with osteoporosis.”

This Amgen and UCB drug is ahead of the other sclerostin antibodies coming through the pipeline for osteoporosis with Eli Lilly’s blosozumab lagging behind in at least the Phase I. Romosozumab is also being developed by Astellas in Japan.

Featured image credit: Human Body © krishnacreations (Stock Photo ID: 5432071)

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