Merck Alzheimer’s drug granted FDA fast-track designation

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Merck’s investigational antibody MK-2214 has received fast-track designation from the FDA for the treatment of Alzheimer’s disease.

MK-2214 targets phosphorylated serine 413 tau (pS413), a marker of abnormal protein accumulation in the brain, according to a Dec. 1 news release from the company. The designation was announced alongside the first-in-human phase 1 trial data to be presented at the Dec. 1-4 Clinical Trials on Alzheimer’s Disease 2025 event in San Diego. The data supported dose selection for an ongoing phase 2 trial.

Merck also shared early clinical results for MK-1167, a separate Alzheimer’s drug candidate that modulates the alpha-7 nicotinic acetylcholine receptor. That drug is being studied in a phase 2 trial.

MK-2214 is being developed in collaboration with Teijin Pharma.

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