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

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 imaging studies.

“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 cognitive function.”

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.

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