Biomarker-driven Patient SelectionUse of a refined plasma biomarker cutoff to enroll patients with low likelihood of Alzheimer pathology is designed to enrich for 'pure' DLB patients and improve the likelihood of detecting drug benefit in Phase 3.
Clinical EfficacyPhase 2b data demonstrated over seventy-five percent slowing of cognitive decline on CDR‑SB in a biomarker-selected DLB subgroup, indicating a potentially meaningful treatment effect.
Regulatory PathwayFDA alignment on a single randomized pivotal Phase 3 trial for neflamapimod establishes a clear regulatory path that could support eventual approval in dementia with Lewy bodies.