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Merck (NYSE:MRK), known as MSD outside the United States and Canada, today provided an update on the development program for MK-8931, a novel investigational oral β-amyloid precursor protein site-cleaving enzyme (BACE) inhibitor. The Data Monitoring Committee (DMC) for the Phase II/III “EPOCH” study in patients with mild to moderate Alzheimer's disease recently completed its planned interim safety analysis and recommended that the trial continue to recruit patients, with no changes to the protocol.
The DMC recommendation was made following a planned analysis of interim safety data that included a safety cohort of 200 patients treated with MK-8931 for at least 3 months. Based upon the DMC’s recommendations, Merck will continue enrollment of the EPOCH study. In addition, Merck will initiate dosing in a new Phase III study (APECS study) evaluating MK-8931 in patients with amnestic mild cognitive impairment due to Alzheimer's disease, also known as prodromal Alzheimer’s disease.
“We are pleased to receive the DMC’s recommendation and look forward to continuing the clinical development program for MK-8931,” said Dr. David Michelson, vice president, Neuroscience, Merck Research Laboratories. “Studies to evaluate potential new treatment options are critical as the global health and financial burden of Alzheimer’s disease grows.”
About the EPOCH StudyEPOCH is a randomized, placebo-controlled, parallel-group, double-blind Phase II/III clinical trial to evaluate the efficacy and safety of two oral doses of MK-8931 (12 and 40 mg) administered daily versus placebo in patients with mild to moderate Alzheimer’s disease. The Phase II portion of the trial also included a 60 mg dose to evaluate safety. The trial is anticipated to enroll up to 1,960 patients. 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 following 78 weeks of treatment.
About the APECS StudyAPECS is a randomized, placebo-controlled, parallel-group, double-blind Phase III clinical trial to evaluate the efficacy and safety of MK-8931 in subjects with prodromal Alzheimer’s disease. The study is designed to enroll 1500 participants. Patients will be randomized to receive placebo, or 12 mg or 40 mg MK-8931, once daily. The primary efficacy outcome of the study is change from baseline in the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) score following 104 weeks of treatment.
About BACE Inhibition and MK-8931
The amyloid hypothesis asserts that the formation of amyloid peptides that lead to amyloid plaque deposits in the brain is a primary contributor to the underlying cause of Alzheimer's disease. BACE is believed to be a key enzyme in the production of amyloid β peptide. Evidence suggests that inhibiting BACE decreases the production of amyloid β peptide and may therefore reduce amyloid plaque formation and modify Alzheimer’s disease progression.