US pharma giant Merck, known as MSD outside the US and Canada, has announced that it will present first-in-human data for two Alzheimer’s drug candidates, MK-2214 and MK-1167, at the Clinical Trials on Alzheimer’s Disease (CTAD) 2025 conference in San Diego from Dec. 1-4.

 

The company also revealed that MK-2214, a novel antibody targeting abnormal tau accumulation in the brain, has received Fast Track Designation from the U.S. Food and Drug Administration. The designation is designed to accelerate the development and review of treatments for serious conditions that address unmet medical needs.

 

MK-2214: Merck will share results from three Phase 1 studies evaluating safety, tolerability, and pharmacokinetics of MK-2214. Two trials involved single ascending doses in healthy volunteers, while a third tested multiple ascending doses in patients with mild cognitive impairment and mild-to-moderate Alzheimer’s disease. These early studies are informing an ongoing Phase 2 trial assessing safety, efficacy, and brain changes in people with early Alzheimer’s disease.

 

MK-1167: Data from a Phase 1 first-in-human study of MK-1167, an oral modulator of the alpha-7 nicotinic acetylcholine receptor, will also be presented. The trial measured the impact of single doses on glutamate metabolism in the prefrontal cortex of healthy male volunteers, using 13C-magnetic resonance spectroscopy. Results are guiding dose selection for a Phase 2 study investigating effects on memory and cognitive function in patients with mild-to-moderate Alzheimer’s disease taking donepezil.

 

“Alzheimer’s disease remains one of the greatest neurological challenges of our time and yet new insights are providing important new paths to evaluate potential new therapeutic approaches,” said Dr Mike Egan, vice president, neuroscience, global clinical development, Merck Research Laboratories. “We are pleased to share data showing progress in our pipeline of candidates targeting Alzheimer’s disease at CTAD 2025.”