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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

EPOCH
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 www.clinicaltrials.gov.

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. In
February 2017, Merck announced that the study was fully enrolled. For
further information please see NCT01953601 at www.clinicaltrials.gov.

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 www.merck.com
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Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA

This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the
“company”) includes “forward-looking statements” within the meaning of
the safe harbor provisions of the U.S. Private Securities Litigation
Reform Act of 1995. These statements are based upon the current beliefs
and expectations of the company’s management and are subject to
significant risks and uncertainties. There can be no guarantees with
respect to pipeline products that the products will receive the
necessary regulatory approvals or that they will prove to be
commercially successful. If underlying assumptions prove inaccurate or
risks or uncertainties materialize, actual results may differ materially
from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry
conditions and competition; general economic factors, including interest
rate and currency exchange rate fluctuations; the impact of
pharmaceutical industry regulation and health care legislation in the
United States and internationally; global trends toward health care cost
containment; technological advances, new products and patents attained
by competitors; challenges inherent in new product development,
including obtaining regulatory approval; the company’s ability to
accurately predict future market conditions; manufacturing difficulties
or delays; financial instability of international economies and
sovereign risk; dependence on the effectiveness of the company’s patents
and other protections for innovative products; and the exposure to
litigation, including patent litigation, and/or regulatory actions.

The company 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 the company’s 2015 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).

Merck
Media:
Pamela Eisele, 267-305-3558
Ian McConnell, 908-740-1921
or
Investors:
Teri Loxam, 908-740-1986
Amy Klug, 908-740-1898