Merck Announces Discontinuation of APECS Study Evaluating Verubecestat (MK-8931) for the Treatment of People with Prodromal A...
February 13 2018 - 4:30PM
Business Wire
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 diseases.”
About the APECS StudyAPECS 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 www.clinicaltrials.gov.
About MerckFor 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 more information, visit www.merck.com and connect with
us on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Forward-Looking Statement of Merck & Co., Inc.,
Kenilworth, N.J., USAThis 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 2016
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).
View source
version on businesswire.com: http://www.businesswire.com/news/home/20180213006582/en/
MerckMedia:Pam Eisele, 267-305-3558orIan McConnell,
908-740-1921orInvestors:Teri Loxam, 908-740-1986orAmy Klug,
908-740-1898
Merck (NYSE:MRK)
Historical Stock Chart
From Aug 2024 to Sep 2024
Merck (NYSE:MRK)
Historical Stock Chart
From Sep 2023 to Sep 2024