CervoMed’s Neflamapimod Yields 1.11-Point CDR-SB Benefit in DLB Patients
CervoMed’s Phase 2b trial data show DLB patients with plasma pTau181 under 21 pg/mL achieved a 1.11-point CDR-SB improvement (p=0.005) on neflamapimod batch B. PK/PD analyses establish a 4 ng/mL trough target and endorse a 50 mg TID regimen for the impending Phase 3.
1. Phase 2b Subgroup Analysis
New stratified analyses of the RewinD-LB trial show DLB patients with lower plasma pTau181 levels experienced progressively greater clinical benefit when switched from batch A to batch B neflamapimod. Those below the 21 pg/mL cutoff—estimated to exclude 80%–90% of patients with Alzheimer’s co-pathology—demonstrated a mean CDR-SB improvement of 1.11 points (p=0.005) and corresponding gains on the ADCS-CGIC scale.
2. PK/PD Findings and Phase 3 Design
PK/PD evaluations identify a trough plasma concentration of 4 ng/mL as the threshold for therapeutic activity, consistent with prior studies. These data underpin the selection of a 50 mg TID dosing regimen and the use of a <21 pg/mL pTau181 enrichment criterion in the planned Phase 3 trial, targeting patients most likely to benefit.