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Merck Completes Enrollment in Pivotal Phase 3 “EPOCH” Trial Investigating the Efficacy and Safety of Verubecestat in Patients with Mild-to-Moderate Alzheimer’s Disease

KENILWORTH, N.J. -- Merck (NYSE: MRK), known as MSD outside the United States and Canada, today confirmed the completion of enrollment for the EPOCH trial, a Phase 2/3 randomized, placebo-controlled, parallel-group, double-blind study of verubecestat, formerly known as MK-8931, the company’s investigational oral small molecule selective beta secretase (BACE1) inhibitor, in patients with mild-to-moderate Alzheimer’s disease (AD). The ongoing study commenced in November 2012, completed enrollment in the fourth quarter of 2015 and is estimated to reach primary trial completion in July 2017.

“Alzheimer’s disease is a devastating disease for which there are limited available treatments,” said Dr. David Michelson, vice president clinical research, neuroscience, Merck Research Laboratories. “This is an important milestone as we evaluate the efficacy and safety of verubecestat, and understand its potential to help address the significant unmet medical need in this progressive and debilitating disease.”

For more than 10 years, Merck has been researching ways to treat AD across the continuum of the disease—investigating ways to modify disease progression and improve management of symptoms in later stages.

The ongoing EPOCH study is designed to evaluate the safety and efficacy 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. Merck is also investigating the safety and efficacy of verubecestat in the earlier, prodromal phase of AD in an additional Phase 3 clinical trial called APECS. 

About the APECS Study

APECS is a randomized, placebo-controlled, parallel-group, double-blind Phase 3 clinical trial to evaluate the efficacy and safety of MK-8931 in subjects with prodromal Alzheimer’s disease. The study is designed to enroll 1,500 participants. Patients will be randomized to receive placebo, or 12 mg or 40 mg MK-8931, 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 more information about the APECS study, visit www.apecsstudy.com

About BACE Inhibition

The amyloid cascade hypothesis proposes that accumulation of toxic amyloid beta peptides lead to amyloid plaque deposits in the brain. This triggers neurodegeneration in the brain leading to the progressive decline in cognition and function in patients with AD. BACE1 performs the initial step in the amyloid cascade and is believed to be central to the pathology of AD. Evidence suggests that inhibiting BACE1 decreases the production of toxic amyloid β peptide and may therefore reduce amyloid plaque formation and modify AD progression. 

About Merck

Today's Merck is 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

This news release of Merck & Co., Inc., Kenilworth, NJ, USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States 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 healthcare legislation in the United States and internationally; global trends toward healthcare 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 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 2014 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).  

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