Merck Announces Discontinuation of APECS Study Evaluating Verubecestat (MK-8931) for the Treatment of People with Prodromal Alzheimer’s Disease


February 13, 2018 4:30 pm ET

Merck (NYSE: MRK), known as MSD outside the United States and Canada,
today announced that it will be stopping protocol 019, also known as the
APECS study, a Phase 3 study evaluating verubecestat (MK-8931), an
investigational small molecule inhibitor of the beta-site amyloid
precursor protein cleaving enzyme 1 (BACE1), in people with prodromal
Alzheimer’s disease (AD). The decision to stop the study follows a
recommendation by the external Data Monitoring Committee (eDMC), which
assessed overall benefit/risk during a recent interim safety analysis.
The eDMC concluded that it was unlikely that positive benefit/risk could
be established if the trial continued. Data from the APECS study
will be presented at an upcoming medical meeting.

“We are disappointed with this outcome, especially given the lack of
treatment options for patients suffering from Alzheimer’s disease,” said
Dr. Roger M. Perlmutter, president, Merck Research Laboratories. “We are
grateful to the patients and caregivers who participated in this study,
and despite this outcome, Merck remains committed to developing novel
therapies for the treatment of Alzheimer’s and other neurodegenerative

About the APECS Study

APECS 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. For further
information please see NCT01953601 at

About Merck

For more than a century, Merck, a leading global
biopharmaceutical company known as MSD outside of the United States and
Canada, has been inventing for life, bringing forward medicines and
vaccines for many of the world’s most challenging diseases. 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. Today, Merck continues to be at the
forefront of research to advance the prevention and treatment of
diseases that threaten people and communities around the world –
including cancer, cardio-metabolic diseases, emerging animal diseases,
Alzheimer’s disease and infectious diseases including HIV and Ebola. For
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Pam Eisele, 267-305-3558
Ian McConnell, 908-740-1921
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