Merck initiates phase 2 / 3 clinical trials of Alzheimer’s drug

Hannah Blake

pharmaphorum

Merck has begun phase 2 and 3 clinical trials to evaluate the safety and efficacy of MK-8931 versus placebo in patients with mild-to-moderate Alzheimer’s disease.

MK-8931 is Merck's novel investigational oral ?-amyloid precursor protein site-cleaving enzyme (BACE) inhibitor. This is the first drug with this mechanism to advance to this stage of clinical research.

"Merck is committed to advancing the understanding and treatment of Alzheimer's disease. As the global health and financial burden of Alzheimer's disease grows, innovative research is critically needed, and we need to accelerate this research wherever possible. This new study is an important step in our overall strategy to understand the potential of the BACE inhibitor mechanism and MK-8931, our lead compound, in multiple stages of Alzheimer's disease."

Darryle D. Schoepp, Ph.D., senior vice president and head of Neuroscience and Ophthalmology, Merck Research Laboratories.

MK-8931 will be tested in a global, 78-week, multi-center study, called EPOCH, which is designed to initially evaluate the safety of MK-8931 in a group of 200 patients prior to advancing into a larger Phase 3 study. The initial study is anticipated to eventually enroll up to 1,700 patients in the main Phase 3 group.

The primary efficacy outcomes of the study are the change from baseline in Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog) score and the change from baseline in the Alzheimer's Disease Cooperative Study – Activities of Daily Living (ADCS-ADL) score.

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