又一折戟沉沙！默沙东宣布停止APECS研究。该研究旨在评估Verubecestat（MK-8931）治疗前驱期阿尔茨海默病患者

美国东部时间2018年2月13日下午4点半，即中国2018年2月14日（情人节）凌晨5点半，世界制药巨头默沙东公司发布了一篇新闻稿，宣布停止APECS研究。该研究旨在评估Verubecestat（MK-8931）治疗前驱期阿尔茨海默病患者的安全性和有效性。

在美国和加拿大以外被称为默沙东（MSD）的美国默克公司（纽约证券交易所股票代码：MRK）今天宣布，将停止019号临床试验方案，亦被称为APECS研究，这是一项评估verubecestat（MK-8931）的3期研究。

Verubecestat（MK-8931）是处于临床试验阶段的β位点淀粉样蛋白前体蛋白裂解酶1（BACE1）小分子抑制剂，用于治疗前驱期阿尔茨海默病（AD）患者。 停止研究的决定是遵循外部数据监测委员会（eDMC）的建议，该委员会在最近举办的中期安全性分析会议期间评估了整体获益/风险。eDMC认为，如果试验继续进行，确定正面的获益/风险的可能性不大。APECS研究的数据将在即将召开的医学会议上展示。

Roger Perlmutter博士

默沙东研究实验室（Merck Research Laboratories）总裁Roger M. Perlmutter博士表示：“我们对这一结果感到失望，尤其是考虑到当下阿尔茨海默病患者缺乏可选择的疗法。我们非常感谢参与这项研究的患者和护理人员，纵然结果如此，默沙东将继续致力于开发治疗阿尔茨海默氏病和其它神经退行性疾病的新疗法。”

（图片来源：网络）

医药研发，困难重重！为了攻克影响全人类的阿尔茨海默病，众多跨国药企前赴后继，接二连三折戟沉沙，耗费了大量的资本，用尽了无数的芳华！我们在此向他们致以最崇高的敬礼！情人节之际，请允许我们再次献上这两首歌曲，表达我们此刻的心情！

欢迎感兴趣的朋友们阅读关于阿尔兹海默药物研发的其它文章和这篇新闻稿，了解详情！

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

Tuesday, February 13, 2018 4:30 pm EST

KENILWORTH, N.J.--(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 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 www.clinicaltrials.gov.

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 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., 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 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).

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