The most recent monoclonal antibody against the N-terminal region to enter clinical trials is LY3303560, but the specific epitope has not been released. In the only publicly available data, LY3303560 was shown to preferentially bind tau aggregates over monomers and had acceptable pharmacokinetic properties in preclinical animal models. [110] A Phase 1/2 trial in 110 healthy controls and patients with mild AD concluded in July 2018, but results have not yet been reported (NCT02754830). A second early Phase 1 study started in January 2017, and enrolled 24 patients with MCI for six months of treatment, with concurrent administration of treatment plus amyloid and tau PET tracers (NCT03019536). Lilly’s Phase 2 trial in 285 early AD patients will treat for 80 weeks with a primary clinical endpoint, but tau PET has been included as a secondary endpoint, marking the first use of this imaging biomarker for a tau therapeutic (NCT03518073). The trial is expected to conclude in late 2021.
