Merck Announces EPOCH Study of Verubecestat for the Treatment of People with Mild to Moderate Alzheimer’s Disease to Stop for Lack of Efficacy


February 14, 2017 5:00 pm ET

APECS Study in People with Prodromal Alzheimer’s Disease to Continue

Merck (NYSE: MRK), known as MSD outside the United States and Canada,
today announced that it will be stopping protocol 017, also known as the
EPOCH study, a Phase 2/3 study evaluating verubecestat, an
investigational small molecule inhibitor of the beta-site amyloid
precursor protein cleaving enzyme 1 (BACE1), in people with
mild-to-moderate Alzheimer’s disease (AD). Merck is stopping the study
following the recommendation of the external Data Monitoring Committee
(eDMC), which assessed overall benefit/risk during a recent interim
safety analysis, and determined that there was “virtually no chance of
finding a positive clinical effect.” The eDMC noted that safety signals
observed in the study “are not sufficient to warrant stopping study
017,” and recommended that protocol 019, also known as APECS, which is
evaluating verubecestat in people with prodromal Alzheimer’s disease,
continue unchanged. Results from protocol 019 are expected in February
2019. Results from EPOCH will be analyzed and presented at an upcoming
scientific meeting.

“Alzheimer’s disease is one of the most pressing and daunting medical
issues of our time, with inherent, substantial challenges to developing
an effective disease-modifying therapy for people with mild-to-moderate
disease. Studies such as EPOCH are critical, and we are indebted to the
patients in this study and their caregivers,” said Dr. Roger M.
Perlmutter, president, Merck Research Laboratories. “While we are
disappointed that a benefit was not observed in this study, our work
continues with APECS, which is studying verubecestat in people with less
advanced disease.”

The efficacy and safety of verubecestat was being evaluated in two
pivotal Phase 3 clinical trials: Protocol 017, or EPOCH, in
mild-to-moderate AD, and Protocol 019, or APECS, in prodromal AD.
Patients with mild to moderate AD exhibit detectable and worsening
impairment of cognitive and functional abilities. Patients with
prodromal AD have objective memory problems but relatively normal
functioning in activities of daily living.

About the EPOCH Study

is a Phase 2/3 randomized, placebo-controlled, parallel-group,
double-blind study evaluating the efficacy and safety of two oral doses
of verubecestat (12 mg and 40 mg) administered once-daily versus placebo
in patients with mild-to-moderate AD currently using standard of care
treatment. The primary efficacy outcomes of the study are the change
from baseline in the Alzheimer’s Disease Assessment Scale Cognitive
Subscale (ADAS-Cog) score, as well as the change from baseline in the
Alzheimer’s Disease Cooperative Study – Activities of Daily Living
(ADCS-ADL) score, following 78 weeks of treatment. For more information
about the EPOCH study, visit NCT01739348 at

About the APECS Study

is a randomized, placebo-controlled, parallel-group, double-blind Phase
3 clinical trial evaluating the efficacy and safety of verubecestat in
people with prodromal AD. Subjects are randomized to receive placebo, or
12 mg or 40 mg verubecestat, 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 treatment. In
February 2017, Merck announced that the study was fully enrolled. For
further information please see NCT01953601 at

About Merck

For over a century, Merck has been a global health care 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 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
health care through far-reaching policies, programs, and partnerships.
For more information, visit
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Pamela Eisele, 267-305-3558
Ian McConnell, 908-740-1921
Teri Loxam, 908-740-1986
Amy Klug, 908-740-1898

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