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



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

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

Business Wire

WHITEHOUSE STATION, N.J. -- December 03, 2012

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 www.ADstudyinfo.com
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 www.merck.com 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
(www.sec.gov).

Contact:

Media:
Merck
Caroline Lappetito, 908-423-3046
or
Investors:
Merck
Carol Ferguson, 908-423-4465
Justin Holko, 908-423-5088
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