CervoMed Inc. issued a press release announcing new analyses from its Phase 2b RewinD-LB trial of neflamapimod in dementia with Lewy bodies patients, showing greater clinical benefits in subgroups with lower plasma pTau181 levels indicating absence of Alzheimer’s co-pathology. These data support neflamapimod’s potential mechanism, patient enrichment strategy using pTau181 <21 pg/mL, and 50mg TID dosing for the planned Phase 3 trial.
Key takeaways
New RewinD-LB analyses presented at AD/PD 2026 Conference on March 21, 2026, in Copenhagen.
In patients with pTau181 <21 pg/mL (80-90% without AD co-pathology), DP Batch B vs placebo CDR-SB difference -1.11 (p=0.005).
Therapeutic threshold for neflamapimod: trough plasma concentration of 4 ng/mL.
DP Batch B achieved C_trough ≥4 ng/mL in 75% of participants vs 50% for DP Batch A (p=0.02).
Planned Phase 3 trial in DLB patients with pTau181 <21 pg/mL, 50mg TID dosing, initiation in second half of 2026 subject to funding.
RewinD-LB trial: 159 participants, funded by $21.3 million NIH grant.