Merck Advances Neuroscience Pipeline With Novel Therapies in Phase 2 Studies for Treatment of Alzheimer’s Disease 

Merck, known as MSD outside of the US and Canada, a premier research-intensive biopharmaceutical company, is initiating two Phase 2 clinical studies for MK-2214 and MK-1167, respectively, which are investigational therapies being evaluated for the treatment of Alzheimer’s disease (AD). Both pipeline programs support improved memory and cognitive function and are based on innovative science that is advancing the field forward.

At the Alzheimer’s Association International Conference (AAIC) July 27-31, Merck scientists including lead study author Jonathan Sugam, PhD, principal scientist, neuroscience discovery at Merck & Co. will present a Poster (#102913) showing preclinical data evaluating MK-2214, an investigational novel antibody targeting pathological tau (via pS413) in the brain, revealing robust reductions in tau pathology and spreading of tau seeds.

• Tau pS413 is associated with accumulation of misfolded and hyperphosphorylated tau in the brain, and is a defining feature of Alzheimer’s disease
• Antibodies targeting extracellular tau have been proposed as a therapeutic strategy to reduce the spread of pathology and slow the disease progression
• Poster #102913, entitled Preclinical development of MK-2214 a novel antibody targeting pS413 tau for the treatment of Alzheimer’s disease, supports clinical development of the drug candidate as an optimal tau antibody to slow the progression of Alzheimer’s disease

The data also demonstrates that the extended half-life of MK-2214 supports a favorable therapeutic profile for future ease of administration, enabling the potential for widespread access. MK-2214 is currently being evaluated in a Phase 2 clinical trial for the treatment of early mild cognitive impairment (MCI) or mild Alzheimer’s disease.

“The pre-clinical data we presented at AAIC is exciting because growing evidence suggests that antibodies targeting accumulated, hyperphosphorylated, extracellular tau could potentially reduce the spread of pathology and slow the progression of Alzheimer’s disease,” said Jason Uslaner, Vice President, Head of Discovery Neuroscience, Merck & Co. “Extended half-life antibodies represent a promising advancement for the management of neuroimmune-mediated diseases, including AD. We look forward to learning more and reporting future results.”

Complementing the Merck pipeline of innovative AD treatments, the company simultaneously is advancing MK-1167, an investigational alpha-7 positive allosteric modulator (PAM) drug being evaluated in a Phase 2a/2b trial as an adjunctive treatment for cognitive deficits associated with mild-to-moderate Alzheimer’s disease dementia. It is the leading compound with next-gen pharmacodynamics, designed to specifically target and facilitate the activity of a key neurotransmitter, acetylcholine, to compensate for its loss of function in AD dementia, and to show efficacy when added to stable acetylcholinesterase inhibitors (AChEI) therapy. Acetylcholine is essential for various bodily functions including memory, muscle movement, attention, arousal and even the immune response.

“We are excited to progress research that has the potential to improve patients’ lives by impacting Alzheimer’s symptoms and disease progression,” said Mike Egan, Vice President, Head of Clinical Neuroscience, Merck & Co.  “What makes these two investigational candidates differentiated is the targeting of core pathologies in Alzheimer’s disease. ​ These two clinical trials are examples of Merck’s commitment to building on our legacy of neuroscience treatments with an innovative pipeline of investigational, research-backed treatments, medicines and therapies that support our science-led strategy.”

It is estimated that one in three people will develop a neurological disorder at some point in their lives, making neurological disorders one of the leading causes of disability and one of the top ten leading causes of death worldwide–with the burden of these diseases increasing as the world population ages. AD affects approximately seven million people in the US, and it is estimated that this number will rise to nearly 14 million by 2060.

We are committed to investing in neurology research, with the goal of advancing the ability to treat, slow progression or prevent devastating central nervous system and peripheral system disorders. The world class Merck neuroscience team is collaborating with scientists and investigators worldwide to advance innovations and find solutions for complex and debilitating neurological diseases including Alzheimer’s disease, chronic and acute pain and Parkinson’s disease.  To learn more about Merck neuroscience visit www.merck.com/research/neuroscience.