Dec. 10, 2013 8:08 a.m. ET
Merck & Co. said it received approval to continue recruiting patients for a trial of its Alzheimer's treatment currently in development.
The Data Monitoring Committee completed its planned interim safety analysis of Merck's Phase II/III EPOCH study. Merck initially agreed to a deal with Luminex Corp. in March to develop a device that could help screen patients for the study of its drug.
The DMC investigated data collected from the Phase II/III study, which treated 200 patients with mild to moderate Alzheimer's with Merck's MK-8931 drug, a novel oral beta amyloid precursor protein site cleaving enzyme inhibitor, for at least three months.
The accumulation of beta amyloid in the brain is considered a key pathological characteristic related to Alzheimer's, according to Merck.
Based on the DMC's recommendations, Merck may continue enrolling patients in the study. Merck will also begin a new Phase III, APEC, study to evaluate how MK-8931 affects patients with prodromal Alzheimer's disease—when the patient has mild cognitive impairment.
"We are pleased to receive the DMC's recommendation and look forward to continuing the clinical development program for MK-8931," said David Michelson, vice president of neuroscience. "Studies to evaluate potential new treatment options are critical as the global health and financial burden of Alzheimer's disease grows."
Merck and other drug manufacturers have increased their focus on Alzheimer's treatments but have faced numerous setbacks.
Peer Eli Lilly & Co. terminated a mid-stage clinical trial of an experimental Alzheimer's disease drug in June after four patients had abnormal liver biochemical tests.
Other companies have experienced setbacks in developing new Alzheimer's therapies, including Pfizer Inc., Johnson & Johnson and Baxter International Inc.
Write to Everdeen Mason at Everdeen.Mason@wsj.com[1]
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