Merck Advances Development Program for Investigational Alzheimer’s Disease Therapy, MK-8931


December 10, 2013 7:00 am ET

Data Monitoring Committee recommends continuation of Phase II/III EPOCH study in mild to moderate disease patients

Merck also plans to initiate dosing in Phase III study of prodromal disease patients

Merck (NYSE:MRK), known as MSD outside the United States and Canada,
today provided an update on the development program for MK-8931, a novel
investigational oral β-amyloid precursor protein site-cleaving enzyme
(BACE) inhibitor. The Data Monitoring Committee (DMC) for the Phase
II/III “EPOCH” study in patients with mild to moderate Alzheimer’s
disease recently completed its planned interim safety analysis and
recommended that the trial continue to recruit patients, with no changes
to the protocol.

The DMC recommendation was made following a planned analysis of interim
safety data that included a safety cohort of 200 patients treated with
MK-8931 for at least 3 months. Based upon the DMC’s recommendations,
Merck will continue enrollment of the EPOCH study. In addition, Merck
will initiate dosing in a new Phase III study (APECS study) evaluating
MK-8931 in patients with amnestic mild cognitive impairment due to
Alzheimer’s disease, also known as prodromal Alzheimer’s disease.

“We are pleased to receive the DMC’s recommendation and look forward to
continuing the clinical development program for MK-8931,” said Dr. David
Michelson, vice president, Neuroscience, Merck Research Laboratories.
“Studies to evaluate potential new treatment options are critical as the
global health and financial burden of Alzheimer’s disease grows.”

About the EPOCH Study

is a randomized, placebo-controlled, parallel-group, double-blind Phase
II/III clinical trial to evaluate the efficacy and safety of two oral
doses of MK-8931 (12 and 40 mg) administered daily versus placebo in
patients with mild to moderate Alzheimer’s disease. The Phase II portion
of the trial also included a 60 mg dose to evaluate safety. The trial is
anticipated to enroll up to 1,960 patients. 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 following 78 weeks of

About the APECS Study

is a randomized, placebo-controlled, parallel-group, double-blind Phase
III clinical trial to evaluate the efficacy and safety of MK-8931 in
subjects with prodromal Alzheimer’s disease. The study is designed to
enroll 1500 participants. Patients will be randomized to receive
placebo, or 12 mg or 40 mg MK-8931, once daily. The primary efficacy
outcome of the study is change from baseline in the Clinical Dementia
Rating Scale-Sum of Boxes (CDR-SB) score following 104 weeks of

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 a primary
contributor to 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 Alzheimer’s disease progression.

Merck’s Commitment to Patients Suffering from Alzheimer’s Disease

Merck is committed to advancing the understanding and treatment of
Alzheimer’s disease. We are currently evaluating 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 investigational BACE
inhibitor, MK-8931, that is being evaluated in late stage clinical
trials for mild to moderate and prodromal Alzheimer’s disease. In
addition, Merck is conducting a Phase II clinical trial for MK-7622, an
investigational adjunctive therapy to donepezil for the symptomatic
treatment of participants with mild to moderate disease.

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
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Caroline Lappetito, 267-305-7639
Justine O’Malley, 908-423-2021
Carol Ferguson, 908-423-4465
Justin Holko, 908-423-5088

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