Background

MK-2214 is an anti-tau monoclonal antibody. This is likely an antibody to phosphorylated tau created at Teijin Pharma in Japan, and licensed by Merck in 2017 (press release).

Teijin earlier published preclinical work on an anti-pSer413 tau antibody in mouse tauopathy models (Umeda et al., 2015). The antibody recognized pathological tau in AD brain, but not tau in healthy brain. In mice, the antibody improved memory, while reducing hyperphosphorylated tau, tau oligomers, tangle formation, and synapse loss.

Findings

In September 2022, MK-2214 entered Phase 1 with a multiple-ascending-dose trial to assess safety, pharmacokinetics, and pharmacodynamics in adults with MCI or mild-to moderate AD dementia. In the trial, a total of 48 participants, at nine sites in the U.S., will receive three escalating doses by IV infusion approximately 30 days apart, or a placebo. Adverse events, pharmacokinetics, and concentrations of CSF free phospho-tau are the endpoints. Completion is expected in May 2025.

In March 2023, a Phase 1 trial will begin in Japan to test the safety and pharmacokinetics of single 700, 2,100, or 4,200 mg doses in 48 healthy adults.

For details on MK-2214 trials, see clinicaltrials.gov.