(By Balaseshan) Merck & Co. Inc. (NYSE: MRK) said it has initiated a Phase 2/3 clinical trial designed to evaluate the safety and efficacy of MK-8931 versus placebo in patients with mild-to-moderate Alzheimer's disease.
The global, multi-center study, called EPOCH, is designed to initially evaluate the safety of MK-8931 in a cohort of 200 patients prior to advancing into a larger Phase 3 study.
"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," said Darryle Schoepp, senior vice president and head of Neuroscience and Ophthalmology, Merck Research Laboratories.
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EPOCH is a 78-week, randomized, placebo-controlled, parallel-group, double-blind Phase 2/3 clinical trial to evaluate the efficacy and safety of one of three oral doses of MK-8931 (12, 40 or 60 mg) administered daily versus placebo. The study is expected to eventually enroll up to 1,700 patients in the main Phase 3 cohort.
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.
MK-8931 is Merck's novel investigational oral ß-amyloid precursor protein site-cleaving enzyme (BACE) inhibitor, and is the first with this mechanism to advance to this stage of clinical research.
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MRK closed Friday's regular session down 0.92% at $44.30. The stock has been trading between $34.86 and $48 for the past 52 weeks.