We are committed to improving health and well-being around the world. From developing new therapies that treat and prevent disease to helping people in need, we are guided by a rich legacy and inspired by a shared vision.
Merck, known as MSD outside the United States and Canada, today presented Phase I data evaluating the safety and tolerability of its novel, oral β-amyloid precursor protein site cleaving enzyme (BACE) inhibitor, MK-8931, being investigated as a potential treatment for Alzheimer's disease. The results, evaluating MK-8931 in healthy volunteers, were presented during the 64th American Academy of Neurology (AAN) Annual meeting being held today in New Orleans.
"We are currently conducting further studies to support initiation of clinical trials in patients with Alzheimer's disease," said Mark S. Forman, M.D., PhD, director of clinical research, Merck Research Laboratories. "MK-8931 provides a unique opportunity to test the amyloid hypothesis of Alzheimer's disease pathogenesis."
Dr. Forman's presentation entitled "The Novel BACE Inhibitor MK-8931 Dramatically Lowers CSF (cerebral spinal fluid) Amyloid β Peptides in Healthy Subjects: Results from a Rising Single Dose Study" described the results of a twopart randomized, double-blind, placebo-controlled single dose study evaluating the safety and tolerability of MK-8931 in 40 healthy adults 18 to 45 years of age. Single doses of MK-8931 were associated with marked reductions in amyloid beta peptide concentrations levels with a mean reduction from baseline of up to 92 percent. MK-8931 was generally well tolerated in these healthy subjects with no serious adverse events and no study discontinuations. Adverse events were generally mild to moderate in intensity and transient in duration and included headache (57% and 50%), nasal congestion (23% and 30%) and dizziness (20% and 40%, for MK-8931 and placebo respectively).
"We are continuing to advance our BACE inhibitor program and anticipate initiating the next stage of clinical development in 2012," said Darryle D. Schoepp, Ph.D., senior vice president and head of Neuroscience and Ophthalmology franchise, Merck Research Laboratories.
Results of this Phase I study were also featured in the Scientific Highlights Session of the AAN meeting during the Geriatric Neurology Section held on April 25. Initial clinical data for MK-8931 were previously presented by Dr. Schoepp at Merck's R&D and Business Briefing held on November 10, 2011.
The amyloid hypothesis predicts that abnormal accumulation of amyloid-β peptide is a central event in the progression of Alzheimer's disease. The enzyme BACE is a key enzyme in the initiation of synthesis of amyloid β peptide. Inhibition of BACE is therefore believed to provide a promising means for therapeutic intervention in Alzheimer's disease.
Today's Merck is a global healthcare 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 consumer care 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 healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebook and YouTube.
Merck Forward-Looking Statement
This news release includes "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Such statements may include, but are not limited to, statements about the benefits of the merger between Merck and Schering-Plough, including future financial and operating results, the combined company's plans, objectives, expectations and intentions and other statements that are not historical facts. Such statements are based upon the current beliefs and expectations of Merck's management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements.
The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the possibility that all of the expected synergies from the merger of Merck and Schering-Plough will not be realized, or will not be realized within the expected time period; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; Merck's ability to accurately predict future market conditions; dependence on the effectiveness of Merck's patents and other protections for innovative products; and the exposure to litigation and/or regulatory actions.
Merck 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 Merck's 2011 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).