Merck And GE Healthcare Collaborate On Use Of Imaging Biomarkers For Investigational BACE Inhibitor Clinical Development Program

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 .

About [ ¹⁸ F]Flutemetamol

[ 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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