Merck Presents Results of a Phase I Clinical Trial Evaluating Investigational BACE inhibitor MK-8931 at American Academy of Neurology
April 27, 2012 7:08 am ET
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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