Merck Announces EPOCH Study of Verubecestat for the Treatment of People with Mild to Moderate Alzheimer’s Disease to Stop f...
February 14 2017 - 05:00PM
Business Wire
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 and connect with us on Twitter, Facebook, YouTube and
LinkedIn.
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
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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
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MerckMedia:Pamela Eisele, 267-305-3558Ian McConnell,
908-740-1921orInvestors:Teri Loxam, 908-740-1986Amy Klug,
908-740-1898
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