"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"
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.
Today's Merck is a global healthcare leader working to help the world be
well. Merck is known as MSD outside the United States and Canada.
Through our prescription medicines, vaccines, biologic therapies, and
consumer care and animal health products, we work with customers and
operate in more than 140 countries to deliver innovative health
solutions. We also demonstrate our commitment to increasing access to
healthcare through far-reaching policies, programs and partnerships. For
more information, visit www.merck.com
and connect with us on Twitter, Facebook and YouTube.
Merck Forward-Looking Statement
This news release includes "forward-looking statements" within the
meaning of the safe harbor provisions of the United States Private
Securities Litigation Reform Act of 1995. Such statements may include,
but are not limited to, statements about the benefits of the merger
between Merck and Schering-Plough, including future financial and
operating results, the combined company's plans, objectives,
expectations and intentions and other statements that are not historical
facts. Such statements are based upon the current beliefs and
expectations of Merck's management and are subject to significant risks
and uncertainties. Actual results may differ from those set forth in the
The following factors, among others, could cause actual results to
differ from those set forth in the forward-looking statements: the
possibility that all of the expected synergies from the merger of Merck
and Schering-Plough will not be realized, or will not be realized within
the expected time period; the impact of pharmaceutical industry
regulation and health care legislation in the United States and
internationally; Merck's ability to accurately predict future market
conditions; dependence on the effectiveness of Merck's patents and other
protections for innovative products; and the exposure to litigation
and/or regulatory actions.
Merck undertakes no obligation to publicly update any forward-looking
statement, whether as a result of new information, future events or
otherwise. Additional factors that could cause results to differ
materially from those described in the forward-looking statements can be
found in Merck's 2011 Annual Report on Form 10-K and the company's other
filings with the Securities and Exchange Commission (SEC) available at
the SEC's Internet site (www.sec.gov).