Amgen and UCB announce positive top-line tesults from phase 3 study evaluating romosozumab In men with osteoporosis

AmgenAmgen (NASDAQ: AMGN) and UCB (Euronext Brussels: UCB) today announced positive top-line results for romosozumab from the pivotal Phase 3 placeBo-contRolled study evaluatIng the efficacy anD safety of romosozumab in treatinG mEn with osteoporosis (BRIDGE). These data showed the BRIDGE study met the primary endpoint, demonstrating a statistically significant increase in bone mineral density (BMD) at the lumbar spine (as assessed by dual energy x-ray absorptiometry) in men with osteoporosis treated with romosozumab compared with placebo at 12 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."

All secondary endpoints comparing romosozumab with placebo were also met. Patients receiving romosozumab experienced a statistically significant increase in BMD at the femoral neck and total hip at 12 months and a statistically significant increase in BMD at the lumbar spine, femoral neck, and total hip at six months, compared with those receiving placebo.

"Although there has been considerable progress in the treatment and management of osteoporosis, a large unmet medical need remains. One in three women and one in five men over the age of 50 will experience an osteoporosis-related fracture in their lives,"3,4 said Professor Dr. Iris Loew-Friedrich, chief medical officer and executive vice president, UCB. "These positive results from BRIDGE add to our growing body of Phase 3 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."

In the BRIDGE study, a total of 245 men were randomized 2:1 to receive either 210 mg romosozumab subcutaneous (SC) every month (QM) or matched placebo SC QM for the duration of the 12-month treatment period.

The overall patient incidence of adverse events and serious adverse events (SAEs) was generally balanced between arms. The most frequently reported adverse events (greater than five percent in the romosozumab arm) were nasopharyngitis, back pain, hypertension, headache and constipation. Injection site reactions were reported in 5.5 percent of patients in the romosozumab treatment group and 3.7 percent in the placebo group during the 12-month period. Most injection site reactions were reported as mild in severity. 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. The patient incidence of positively adjudicated cardiovascular death was 0.6 percent (1/163) in the romosozumab group and 1.2 percent (1/81) in the placebo group. Amgen and UCB recently reported the results of the FRAME study in 7,180 postmenopausal women with osteoporosis in which the overall patient incidences of adjudicated CV SAEs were balanced.

Further analysis of the Phase 3 BRIDGE study data is ongoing and will be submitted to a future medical conference and for publication. UCB and Amgen plan to discuss these results with global regulators.

About Romosozumab
Romosozumab is an investigational bone-forming monoclonal antibody and is not approved by any regulatory authority for the treatment of osteoporosis. It is designed to work by inhibiting the protein sclerostin, and has a dual effect on bone, both increasing bone formation and decreasing bone breakdown. Romosozumab is being studied for its potential to reduce the risk of fractures in an extensive global Phase 3 program. This program includes two large fracture trials comparing romosozumab to either placebo or active comparator in more than 10,000 postmenopausal women with osteoporosis. Amgen and UCB are co-developing romosozumab.

About the BRIDGE study
BRIDGE is a multi-center, international, randomized, double-blind, placebo-controlled study in men with osteoporosis, defined as low bone mineral density (BMD) at the spine, total hip or femoral neck. The study evaluated the effectiveness of romosozumab treatment for 12 months, compared with placebo, in increasing BMD at the lumbar spine, as well as the effect on BMD at the femoral neck and total hip at 12 months and on BMD at the lumbar spine, femoral neck, and total hip at six months.

About Amgen
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

About UCB
UCB, Brussels, Belgium is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With more than 7 700 people in approximately 40 countries, the company generated revenue of € 3.9 billion in 2015. UCB is listed on Euronext Brussels (symbol: UCB).

Most Popular Now

Delivering insulin in a pill

Given the choice of taking a pill or injecting oneself with a needle, most of us would opt to regulate a chronic health condition by swallowing a pill. But for millions o...

Can aspirin treat Alzheimer's?

A regimen of low-dose aspirin potentially may reduce plaques in the brain, which will reduce Alzheimer's disease pathology and protect memory, according to neurological r...

Probiotics can protect the skeletons of older wome…

For the first time in the world, researchers at the University of Gothenburg, Sweden, have demonstrated that probiotics, dietary supplements with health-promoting bacteri...

Alzheimer's breakthrough: Brain metals that may dr…

Alzheimer's disease could be better treated, thanks to a breakthrough discovery of the properties of the metals in the brain involved in the progression of the neurodegen...

FDA approves first drug comprised of an active ing…

The U.S. Food and Drug Administration today approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated with two rare and severe forms o...

Researchers develop a new method for turning skin …

Our bodies consist of many different kinds of cells, each with their own role. The Japanese scientist Shinya Yamanaka had made earlier the discovery, earning the Nobel Pr...

Some existing anti-cancer drugs may act in part by…

Bolstering the notion that RNA should be considered an important drug-discovery target, scientists at Scripps Research have found that several existing, FDA-approved anti...

FDA takes steps to foster greater efficiency in bi…

Today, the agency withdrew the draft guidance, "Statistical Approaches to Evaluate Analytical Similarity," issued in September 2017. The draft guidance, if finalized as w...

Poliovirus therapy for recurrent glioblastoma has …

A genetically modified poliovirus therapy developed at Duke Cancer Institute shows significantly improved long-term survival for patients with recurrent glioblastoma, wit...

Novartis Clear about Psoriasis survey data highlig…

Novartis announced today the publication of global Clear about Psoriasis survey data in the Journal of the European Academy of Dermatology and Venereology[1]. The publica...

Human clinical trial reveals verapamil as an effec…

Researchers at the University of Alabama at Birmingham Comprehensive Diabetes Center have discovered a safe and effective novel therapy to reduce insulin requirements and...

How targeting metabolism can defeat cancer stem ce…

Researchers are the University of Michigan Rogel Cancer are unraveling a crucial thread that explains why cancer so often becomes resistant to treatment. In a breakthroug...