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Merck, known as MSD outside the United States and Canada, today presented Phase I data evaluating the safety and tolerability of its novel, oral β-amyloid precursor protein site cleaving enzyme (BACE) inhibitor, MK-8931, being investigated as a potential treatment for Alzheimer's disease. The results, evaluating MK-8931 in healthy volunteers, were presented during the 64th American Academy of Neurology (AAN) Annual meeting being held today in New Orleans.
"We are currently conducting further studies to support initiation of clinical trials in patients with Alzheimer's disease," said Mark S. Forman, M.D., PhD, director of clinical research, Merck Research Laboratories. "MK-8931 provides a unique opportunity to test the amyloid hypothesis of Alzheimer's disease pathogenesis."
Dr. Forman's presentation entitled "The Novel BACE Inhibitor MK-8931 Dramatically Lowers CSF (cerebral spinal fluid) Amyloid β Peptides in Healthy Subjects: Results from a Rising Single Dose Study" described the results of a twopart randomized, double-blind, placebo-controlled single dose study evaluating the safety and tolerability of MK-8931 in 40 healthy adults 18 to 45 years of age. Single doses of MK-8931 were associated with marked reductions in amyloid beta peptide concentrations levels with a mean reduction from baseline of up to 92 percent. MK-8931 was generally well tolerated in these healthy subjects with no serious adverse events and no study discontinuations. Adverse events were generally mild to moderate in intensity and transient in duration and included headache (57% and 50%), nasal congestion (23% and 30%) and dizziness (20% and 40%, for MK-8931 and placebo respectively).
"We are continuing to advance our BACE inhibitor program and anticipate initiating the next stage of clinical development in 2012," said Darryle D. Schoepp, Ph.D., senior vice president and head of Neuroscience and Ophthalmology franchise, Merck Research Laboratories.
Results of this Phase I study were also featured in the Scientific Highlights Session of the AAN meeting during the Geriatric Neurology Section held on April 25. Initial clinical data for MK-8931 were previously presented by Dr. Schoepp at Merck's R&D and Business Briefing held on November 10, 2011.
The amyloid hypothesis predicts that abnormal accumulation of amyloid-β peptide is a central event in the progression of Alzheimer's disease. The enzyme BACE is a key enzyme in the initiation of synthesis of amyloid β peptide. Inhibition of BACE is therefore believed to provide a promising means for therapeutic intervention in Alzheimer's disease.
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