A Merck & Co. Alzheimer's drug under development will advance into late-stage trials upon the recommendation of an independent committee, the Hunterdon County pharmaceutical company said Tuesday.
The federal government's Data Monitoring Committee recommended that studies of the effectiveness of Merck's drug, named MK-8931, on patients with mild to moderate versions of Alzheimer's continue with increased enrollment.
The DMC made its recommendation after analyzing safety data from a mid-stage trial of 200 patients treated with the oral drug for at least three months.
Merck will continue with a late-stage, or Phase III, trial on up to 1,960 patients with mild to moderate Alzheimer's disease. The additional study will take place over 78 weeks.
The pharmaceutical company will also begin a separate late-stage trial on 1,500 patients with mild cognitive impairment caused by Alzheimer's. That early stage is also known as prodromal Alzheimer's disease. That study will take place over two years.
"We are pleased to receive the DMC's recommendation and look forward to continuing the clinical development program for MK-8931," David Michelson, a vice president specializing in neuroscience at Merck Research Laboratories, said in a statement.
"Studies to evaluate potential new treatment options are critical as the global health and financial burden of Alzheimer's disease grows," Michelson said.
About 5.2 million Americans and 44 million people worldwide suffer from Alzheimer's disease, a form of dementia, according to groups that study the disease. Those numbers are expected to grow as the population aged 65 and older increases.
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