By Fineline Cube 
Merck Sharp & Dohme Inc. (MSD, NYSE: MRK) released first‑in‑human data for MK-2214 and MK-1167 in Alzheimer’s disease (AD), while announcing that MK-2214 has been granted FDA Fast Track Designation for AD treatment.
Regulatory Milestone & Drug Profile
| Asset | Target | Mechanism | Regulatory Status |
|---|---|---|---|
| MK-2214 | Phosphorylated serine 413 (pS413) tau | Novel antibody (co‑developed with Teijin Pharma) | FDA Fast Track Designation granted |
| MK-1167 | Alpha‑7 (α7) nicotinic acetylcholine receptor | Oral positive allosteric modulator | Phase 1 completed; Phase 2 ongoing |
MK-2214: Phase 1 Data & Development Path
Study Design: Three Phase 1 studies in healthy volunteers and individuals with mild cognitive impairment and mild‑to‑moderate AD
Key Findings:
- Safety & Tolerability: Favorable profile across all dose cohorts
- Pharmacokinetics: Linear PK supporting once‑monthly subcutaneous dosing
- Target Engagement: Demonstrated robust reduction of pS413 tau in CSF
Next Steps: Phase 2/3 study initiation planned for Q2 2026
MK-1167: Phase 1 Study & Dose Selection
Study Design: First‑in‑human single‑dose study in healthy adult male volunteers
Key Findings:
- Glutamate Metabolism: Measurable effect on prefrontal cortex glutamate levels, supporting mechanism of action
- Safety: Well‑tolerated at all tested doses
- PK/PD: Dose‑dependent receptor occupancy established
Clinical Relevance: Data informed dose selection for ongoing Phase 2 trial in AD patients
Alzheimer’s Market Context & Strategic Outlook
- Disease Burden: 6.5 million AD patients in US; global market projected $10 billion by 2030
- Tau Pathway: pS413 tau represents novel epitope for intervention; MK-2214 offers differentiated approach vs. anti‑amyloid antibodies
- Fast Track Impact: Accelerates review timeline; enables rolling submission and more frequent FDA interaction
- Combination Potential: α7 nicotinic modulation (MK-1167) may provide symptomatic benefit while MK-2214 targets disease progression
- Pipeline Value: Two mechanistically distinct assets position MSD as leader in next‑generation AD therapeutics
Forward‑Looking Statements
This brief contains forward‑looking statements regarding MK-2214 and MK-1167 development timelines, clinical outcomes, and regulatory interactions. Actual results may differ due to clinical, regulatory, and competitive uncertainties.-Fineline Info & Tech