Merck and GE Healthcare Collaborate on Use of Imaging Biomarkers for Investigational BACE inhibitor Clinical Development Program
December 18, 2012 7:30 am ET
Merck (NYSE: MRK), known as MSD outside the United States and Canada,
and GE Healthcare today announced a clinical study collaboration,
license and supply agreement for use of [18F]Flutemetamol, an
investigational positron emission tomography (PET) imaging agent, to
support Merck’s development of MK-8931, a novel oral beta amyloid
precursor protein site cleaving enzyme (BACE) inhibitor and Merck’s lead
investigational candidate for Alzheimer’s disease (AD).
Accumulation of beta amyloid in the brain is a pathological
characteristic related to Alzheimer’s disease. Currently, AD is
diagnosed by clinical examination (i.e., medical history, physical,
neurological, psychiatric and neuropsychological exams, laboratory tests
and Magnetic Resonance Imaging [MRI] or Computed Tomography [CT] scan).
An AD diagnosis can only be confirmed through histopathological
identification of characteristic features, including beta amyloid
plaques, in post-mortem brain samples.
“There is a serious unmet need for a reliable method for measuring beta
amyloid deposits to help physicians diagnose Alzheimer’s disease at its
different stages and study its progression,” said Darryle Schoepp,
Ph.D., senior vice president, head of neuroscience and ophthalmology,
Merck Research Laboratories. “This agreement will allow us to employ an
investigational imaging agent to help identify patients who might
benefit from an anti-amyloid therapy and enable clinical evaluation of
our lead BACE inhibitor candidate for Alzheimer’s disease, MK-8931.”
Under the agreement, GE Healthcare will supply [18F]Flutemetamol
to help select patients for clinical trials and evaluate this
investigational agent as a companion diagnostic tool. A joint Merck and
GE Healthcare Imaging Advisory Committee will oversee the planned
“In clinical trials, [18F]Flutemetamol demonstrated
consistent performance in the visual detection of beta amyloid in the
brain when compared with histopathology data,” said Jonathan Allis,
general manager, PET, GE Healthcare Medical Diagnostics. “[18F]Flutemetamol
imaging has the potential to be part of a larger diagnostic workup that
may help doctors rule out Alzheimer’s disease by reliably showing the
absence of amyloid deposits in patients with unexplained loss of
About Merck’s BACE Inhibitor Development Program and MK-8931
Merck is advancing several innovative programs in Alzheimer’s disease,
including candidates designed to modify disease progression as well as
improve symptom control. Merck’s lead candidate in disease modification
is MK-8931, an investigational oral BACE inhibitor.
Results of Phase I clinical studies demonstrated that MK-8931 can reduce
cerebral spinal fluid (CSF) beta amyloid by greater than 90 percent in
healthy volunteers without dose limiting side effects. Based on these
results, Merck is moving forward with a global, multi-center Phase
II/III clinical trial, called EPOCH, to evaluate the safety and efficacy
of MK-8931 versus placebo in patients with mild-to-moderate AD. For more
information about the EPOCH study please visit www.ADstudyinfo.com
or call 1-855-55-EPOCH (37624). Information is also available at www.clinicaltrials.gov.
[18F]Flutemetamol is an investigational PET imaging agent
being developed by GE Healthcare for the detection of beta amyloid
deposits in the brain. Pooled results from Phase III brain autopsy and
biopsy studies showed a strong concordance between [18F]Flutemetamol
images and AD-associated beta amyloid brain pathology. Phase III studies
demonstrated [18F]Flutemetamol visual detection of beta amyloid with a
majority read sensitivity of 86 percent and specificity of 92 percent.
About Alzheimer’s Disease and Amyloid Hypothesis
Alzheimer’s disease (AD) is a devastating, irreversible and ultimately
fatal disease that progressively destroys neurons in the brain, leading
to a deterioration of cognitive function. The symptoms include loss of
memory that progresses into behavioral changes, alterations in thinking
and reasoning skills that interfere with daily activities, and dementia.
AD is the most common cause of dementia, accounting for approximately
50-75 percent of the estimated 35 million dementia cases globally.1,2
About 5.4 million people in the United States are currently living with
AD.3 There are currently no disease-modifying treatments
available for AD, and current treatment options are limited to providing
symptomatic improvements with only modest and short-term effects.
While the exact cause of AD remains unknown, a current prevailing theory
asserts that AD occurs due to the accumulation of beta amyloid proteins
in the brain. Beta amyloid precursor protein site cleaving enzyme (BACE)
is believed to be a key enzyme in the production of beta amyloid
peptide. Evidence suggests that inhibiting BACE decreases the production
of beta amyloid and may therefore reduce amyloid plaque formation and
modify disease progression.
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1 Alzheimer’s Disease International. Types of Dementia:
Alzheimer’s Disease. Available at: http://www.alz.co.uk/info/alzheimers-disease.
2 Alzheimer’s Disease International. Dementia Statistics.
Available at: http://www.alz.co.uk/research/statistics.
3 Alzheimer’s Association. Alzheimer’s Fact and Figures.
Available at: http://www.alz.org/alzheimers_disease_facts_and_figures.asp
Caroline Lappetito, 267-305-7639
Aleisia Gibson, 201-289-3832
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