Amgen
AMGN and UCB (Euronext Brussels: UCB) today presented additional
findings from an exploratory sub-study of the previously reported
romosozumab Phase 2 trial.(1) The findings were presented today in an oral
plenary session at the American Society for Bone and Mineral Research
(ASBMR) 2015 Annual Meeting in Seattle.
The small exploratory sub-study data showed that, at month 12, the
investigational bone-forming agent romosozumab increased estimated bone
strength (percent change from baseline) at the spine and hip more than
open-label teriparatide in postmenopausal women with low bone mass. These
results were measured by a validated method called finite element analysis
(FEA), which utilized quantitative computed tomography (QCT) scans to
simulate compression overload to estimate vertebral strength, and a sideways
fall to estimate femoral strength.(2)
"Engineers and physicists have long used finite element analysis to better
understand the structural integrity and failure of physical objects when
subjected to load," said lead investigator Tony M. Keaveny, Ph.D., professor
of Mechanical Engineering and Bioengineering at the University of
California, Berkeley. "By applying this analysis to bone scans of
postmenopausal women with low bone mass, we were able to integrate the
information we had on bone mineral density and structure to estimate bone
strength in those treated with romosozumab."
The FEA showed that, at the spine, women in the romosozumab group (210 mg
once monthly, n=24) increased estimated strength compared to baseline by
27.3 percent at month 12, which was greater than placebo (--3.9 percent,
n=27) and teriparatide (18.5 percent, n=28).(2) At the hip, the estimated
strength increased from baseline by 3.6 percent with romosozumab (n=9),
compared with placebo (-0.1 percent, n=18) or teriparatide (-0.7 percent,
n=19).(2)
These data are from a small exploratory sub-study (n=79) of a Phase 2 trial
(NCT00896532) that included a total of 419 patients. A subset of these women
underwent spine and hip QCT imaging to measure bone mineral density (BMD)
gains.(3) To investigate the effects of romosozumab on bone strength an FEA
was performed on these QCT scans.
"The strength improvements observed with romosozumab in this trial -- and
documented using a validated method for assessing fracture risk and
monitoring treatment -- further support its potential as a treatment option
for patients at high risk for fracture," said Sean E. Harper, M.D.,
executive vice president of Research and Development at Amgen. "These
important new data support our extensive global Phase 3 program of
romosozumab, and we look forward to advancing this research to help provide
a potential new treatment option for appropriate patients."
Adverse events in the original Phase 2 study were similar across groups,
except for mild, generally non-recurring injection site reactions observed
more frequently with romosozumab compared to placebo, but with no observed
dose-related relationship. The most common adverse events included mild
upper respiratory tract infection, pain in the back and joints, and
headache. These reactions did not lead to study drug discontinuation or
study withdrawal; the safety of romosozumab will be further addressed in
subsequent larger studies.
"These data illustrate the potential impact of building bone through both
increasing bone formation and decreasing bone resorption as romosozumab has
demonstrated in skeletal regions of interest. These sub-study results
reinforce our confidence in the ability of romosozumab to build bone
strength as well as density and we look forward to reporting the outcomes of
the first fracture study in 2016," said Professor Dr. Iris Loew-Friedrich,
chief medical officer and executive vice president at UCB.
About Finite Element Analysis
Finite element analysis (FEA) is a computer model of a material or design
that is stressed and analyzed and tested for specific results. This involves
breaking down an object into a large number of finite elements (e.g., small
cubes), and using mathematical equations to help predict the behavior of
each element. These behaviors are then calculated by a computer to predict
the behavior of the object as a whole.
FEA has been applied for the past 40 years to simulate the mechanical
behavior of bone, helping to predict strength at major fracture sites, like
the lumbar spine and femoral hip.
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, thereby
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 evaluating the safety and
efficacy of romosozumab includes two large fracture trials comparing
romosozumab to either placebo or active comparator in more than 10,000
postmenopausal patients with osteoporosis. Primary results from the Phase 3
study FRAME are expected in the first half of 2016. Romosozumab is being
co-developed by Amgen and UCB.
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