Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced plans to present first-in-human data for MK-2214 and MK-1167 at Clinical Trials on Alzheimer's Disease (CTAD) 2025 in San Diego, California from Dec. 1-4. In addition, the company announced that MK-2214, a novel candidate targeting the abnormal accumulation and aggregation of tau in the brain, has been granted Fast Track Designation by the U.S. Food and Drug Administration for the treatment of Alzheimer's disease. Fast Track is a process designed to facilitate the development and expedite the review of drug candidates to treat serious conditions and address an unmet medical need.
Key data being presented:
- MK-2214, an investigational novel antibody targeting phosphorylated serine 413 (pS413) tau: First presentation of data from three Phase 1 studies evaluating MK-2214. Two studies assessed the safety, tolerability and pharmacokinetics of a single ascending dose of MK-2214 in healthy volunteers, while a third assessed the safety, tolerability and pharmacokinetics of a multiple ascending dose regimen in individuals with mild cognitive impairment and mild-to-moderate Alzheimer's disease. The results from these studies helped inform an ongoing Phase 2 trial of MK-2214 evaluating safety and efficacy, including its effect on certain changes in the brains of people with early Alzheimer's disease ( NCT07033494).
- MK-1167, an investigational oral positive allosteric modulator of the alpha-7 (α7) nicotinic acetylcholine receptor: First presentation of data from a Phase 1 first-in-human study evaluating MK-1167. The trial assessed the effect of single doses of MK-1167 on glutamate metabolism in the prefrontal cortex of healthy adult male volunteers, as measured by 13C-magnetic resonance spectroscopy. The results from this study helped inform dose selection for an ongoing Phase 2 trial of MK-1167 evaluating safety and efficacy, including its effect on memory and mental activity, in people with mild-to-moderate Alzheimer's disease dementia taking stable donepezil treatment ( NCT06721156).
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced plans to present first-in-human data for MK-2214 and MK-1167 at Clinical Trials on Alzheimer's Disease (CTAD) 2025 in San Diego, California from Dec. 1-4. In addition, the company announced that MK-2214, a novel candidate targeting the abnormal accumulation and aggregation of tau in the brain, has been granted Fast Track Designation by the U.S. Food and Drug Administration for the treatment of Alzheimer's disease. Fast Track is a process designed to facilitate the development and expedite the review of drug candidates to treat serious conditions and address an unmet medical need.
**Key data being presented:**
- **MK-2214, an investigational novel antibody targeting phosphorylated serine 413 (pS413) tau:** First presentation of data from three Phase 1 studies evaluating MK-2214. Two studies assessed the safety, tolerability and pharmacokinetics of a single ascending dose of MK-2214 in healthy volunteers, while a third assessed the safety, tolerability and pharmacokinetics of a multiple ascending dose regimen in individuals with mild cognitive impairment and mild-to-moderate Alzheimer's disease. The results from these studies helped inform an ongoing Phase 2 trial of MK-2214 evaluating safety and efficacy, including its effect on certain changes in the brains of people with early Alzheimer's disease ( [NCT07033494](https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.clinicaltrials.gov%2Fstudy%2FNCT07033494&esheet=54364249&newsitemid=20251201813248&lan=en-US&anchor=NCT07033494&index=1&md5=9ad711c22eeb6113cf5e7c1669e66a42)).
- **MK-1167, an investigational oral positive allosteric modulator of the alpha-7 (α7) nicotinic acetylcholine receptor:** First presentation of data from a Phase 1 first-in-human study evaluating MK-1167. The trial assessed the effect of single doses of MK-1167 on glutamate metabolism in the prefrontal cortex of healthy adult male volunteers, as measured by 13C-magnetic resonance spectroscopy. The results from this study helped inform dose selection for an ongoing Phase 2 trial of MK-1167 evaluating safety and efficacy, including its effect on memory and mental activity, in people with mild-to-moderate Alzheimer's disease dementia taking stable donepezil treatment ( [NCT06721156](https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT06721156&esheet=54364249&newsitemid=20251201813248&lan=en-US&anchor=NCT06721156&index=2&md5=d5486842a4d5d8edecf506979659c052)).
<p>Merck (NYSE:<a class="ticker" href="https://www.benzinga.com/quote/MRK">MRK</a>), known as MSD outside of the United States and Canada, today announced plans to present first-in-human data for MK-2214 and MK-1167 at Clinical Trials on Alzheimer's Disease (CTAD) 2025 in San Diego, California from Dec. 1-4. In addition, the company announced that MK-2214, a novel candidate targeting the abnormal accumulation and aggregation of tau in the brain, has been granted Fast Track Designation by the U.S. Food and Drug Administration for the treatment of Alzheimer's disease. Fast Track is a process designed to facilitate the development and expedite the review of drug candidates to treat serious conditions and address an unmet medical need.</p><p><strong>Key data being presented:</strong></p><ul><li><strong>MK-2214, an investigational novel antibody targeting phosphorylated serine 413 (pS413) tau:</strong> First presentation of data from three Phase 1 studies evaluating MK-2214. Two studies assessed the safety, tolerability and pharmacokinetics of a single ascending dose of MK-2214 in healthy volunteers, while a third assessed the safety, tolerability and pharmacokinetics of a multiple ascending dose regimen in individuals with mild cognitive impairment and mild-to-moderate Alzheimer's disease. The results from these studies helped inform an ongoing Phase 2 trial of MK-2214 evaluating safety and efficacy, including its effect on certain changes in the brains of people with early Alzheimer's disease (<a href="https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.clinicaltrials.gov%2Fstudy%2FNCT07033494&esheet=54364249&newsitemid=20251201813248&lan=en-US&anchor=NCT07033494&index=1&md5=9ad711c22eeb6113cf5e7c1669e66a42">NCT07033494</a>).</li><li><strong>MK-1167, an investigational oral positive allosteric modulator of the alpha-7 (α7) nicotinic acetylcholine receptor:</strong> First presentation of data from a Phase 1 first-in-human study evaluating MK-1167. The trial assessed the effect of single doses of MK-1167 on glutamate metabolism in the prefrontal cortex of healthy adult male volunteers, as measured by 13C-magnetic resonance spectroscopy. The results from this study helped inform dose selection for an ongoing Phase 2 trial of MK-1167 evaluating safety and efficacy, including its effect on memory and mental activity, in people with mild-to-moderate Alzheimer's disease dementia taking stable donepezil treatment (<a href="https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT06721156&esheet=54364249&newsitemid=20251201813248&lan=en-US&anchor=NCT06721156&index=2&md5=d5486842a4d5d8edecf506979659c052">NCT06721156</a>).</li></ul>