Neflamapimod - (RewinD-LB)

July 14, 2026: CervoMed Inc. (NASDAQ: CRVO) presented new clinical, plasma biomarker and MRI analyses at AAIC 2026 (London) for neflamapimod in dementia with Lewy bodies (DLB), drawing from the 159-patient Phase 2b RewinD-LB trial (16-week randomized placebo-controlled + 32-week extension) and a separate Phase 2 open-label study of 80 mg BID (n=26, 24 weeks). In the placebo-controlled Phase 2b portion, neflamapimod did not replicate earlier Phase 2a CDR-SB benefit; exploratory analyses attributed this to higher-than-target Alzheimer’s co-pathology (elevated screening plasma pTau181) and lower-than-expected drug exposure from one drug product batch. In “pure” DLB (lower pTau181; cited <21 pg/mL cutoff) and in participants achieving higher trough concentrations, treatment effects favored neflamapimod. During the extension, a higher-exposure capsule batch showed a within-participant CDR-SB change of 0.17 vs 0.95 on placebo (p=0.005).

Imaging analyses reported durable slowing/stabilization of right basal forebrain atrophy and increased right basal forebrain–default mode network connectivity vs placebo.

A PK-PD analysis associated ~4 ng/mL trough with biomarker/clinical improvements; the planned Phase 3 dose is 50 mg TID (targeting ~90% achieving this threshold), with reported alignment on the Phase 3 plan with FDA, EMA, MHRA and PMDA. The 80 mg BID Phase 2 study met primary safety/tolerability/PK objectives with no new safety signals; exploratory clinical/biomarker/MRI analyses are ongoing. Upcoming: interim biomarker data from an ongoing Phase 2a nfvPPA study expected early Q4 2026; first patient dosing in the EXPERTS-ALS Phase 2a trial anticipated in Q4 2026.