Merck Initiates Phase II/III Study of Investigational BACE Inhibitor, MK-8931, for Treatment of Alzheimer’s Disease


December 3, 2012 6:30 am ET

Phased study to evaluate safety and efficacy of MK-8931 in patients with mild-to-moderate Alzheimer’s disease

Merck (NYSE: MRK), known as MSD outside the United States and Canada,
announced it has started a Phase II/III clinical trial designed to
evaluate the safety and efficacy of MK-8931 versus placebo in patients
with mild-to-moderate Alzheimer’s disease. MK-8931 is Merck’s novel
investigational oral β-amyloid precursor protein site-cleaving enzyme
(BACE) inhibitor, and is the first with this mechanism to advance to
this stage of clinical research. The global, multi-center study, called
EPOCH, is designed to initially evaluate the safety of MK-8931 in a
cohort of 200 patients prior to advancing into a larger Phase III study.

“Merck is committed to advancing the understanding and treatment of
Alzheimer’s disease,” said Darryle D. Schoepp, Ph.D., senior vice
president and head of Neuroscience and Ophthalmology, Merck Research
Laboratories. “As the global health and financial burden of Alzheimer’s
disease grows, innovative research is critically needed, and we need to
accelerate this research wherever possible. 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.”

About the EPOCH study

EPOCH is a 78-week, randomized, placebo-controlled, parallel-group,
double-blind Phase II/III clinical trial to evaluate the efficacy and
safety of one of three oral doses of MK-8931 (12, 40 or 60 mg)
administered daily versus placebo. The study is anticipated to
eventually enroll up to 1,700 patients in the main Phase III cohort. The
primary efficacy outcomes of the study are the change from baseline in
Alzheimer’s Disease Assessment Scale Cognitive Subscale (ADAS-Cog) score
and the change from baseline in the Alzheimer’s Disease Cooperative
Study – Activities of Daily Living (ADCS-ADL) score.

For more information about the EPOCH study, please visit
or call 1-855-55-EPOCH (37624).

About BACE Inhibition and MK-8931

The amyloid hypothesis asserts that the formation of amyloid peptides
that lead to amyloid plaque deposits in the brain is the underlying
cause of Alzheimer’s disease. BACE is believed to be a key enzyme in the
production of amyloid β peptide. Evidence suggests that inhibiting BACE
decreases the production of amyloid β peptide and may therefore reduce
amyloid plaque formation and modify disease progression.

Earlier this year, Merck researchers presented findings of a multiple
dose Phase I study which demonstrated that MK-8931 can reduce cerebral
spinal fluid (CSF) β-amyloid by greater than 90 percent in healthy
volunteers, without dose limiting side effects.

Merck is advancing several innovative mechanisms in Alzheimer’s disease,
including candidates designed to modify disease progression and improve
symptom control. Merck’s major effort in disease modification is our
lead BACE inhibitor, MK-8931, and Merck is continuing to develop other
BACE inhibitor candidates.

About Merck

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
and connect with us on Twitter, Facebook and YouTube.

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
forward-looking statements.

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 (

Caroline Lappetito, 908-423-3046
Carol Ferguson, 908-423-4465
Justin Holko, 908-423-5088

Unsubscribe from email alerts