Merck & Co. announced Monday the start of a Phase II/III trial of the experimental BACE inhibitor MK-8931 in patients with mild-to-moderate Alzheimer's disease. Darryle D. Schoepp, head of neuroscience and ophthalmology at Merck Research Laboratories, said "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."
The EPOCH trial will initially evaluate the safety of MK-8931 in 200 patients, before comparing three different doses of the oral drug to placebo in up to 1700 patients. The company noted that the 78-week study has a main goal of change from baseline in two scores of Alzheimer's disease. Merck added that MK-8931 is the first BACE inhibitor to advance to this stage of development.
Schoepp said that if the EPOCH trial is positive, Merck would have one of the two studies needed to apply for regulatory approval of MK-8931. In earlier research, the drug blocked the formation of almost all toxic amyloid plaques, he remarked, adding that "no one's ever done that before. If (amyloid) plaques are the cause, the medicine will work." Schoepp noted that Merck also has other compounds in development and plans additional studies, including some in patients with very early Alzheimer's disease.
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