CervoMed Announces New Data at the AD/PD™ 2026 Scientific Conference that Reinforce Neflamapimod's Positive Effects in Dementia with Lewy Bodies (DLB) in Patients without Alzheimer's Disease Co-Pathology

Core Insights - New analyses indicate that dementia with Lewy bodies (DLB) patients with lower plasma pTau181 levels experienced greater clinical benefits from neflamapimod in a Phase 2b clinical trial, suggesting a potential to target the underlying disease biology [1][2][5] - The findings support the company's patient enrichment strategy and dosing regimen for the upcoming Phase 3 trial [1][2] Clinical Trial Details - The RewinD-LB Phase 2b trial included an initial randomized phase comparing neflamapimod to placebo, followed by a neflamapimod-only extension phase [3][10] - In the initial phase, participants did not achieve expected plasma drug concentration levels, resulting in no statistically significant improvement on the primary endpoint [3][4] - The extension phase with a new batch of capsules (DP Batch B) showed statistically significant and clinically meaningful slowing of clinical progression compared to the initial batch [4] Treatment Response and Biomarkers - Treatment response increased progressively across DLB patient subgroups with lower plasma pTau181 levels, indicating a higher likelihood of patients without Alzheimer's disease (AD) co-pathology [2][5] - The analyses revealed a strong association between neflamapimod response and the absence of AD co-pathology, reinforcing confidence in the drug's potential to slow disease progression [2][5] Statistical Findings - Within-participant comparisons showed that at the lowest plasma pTau181 levels (<21 pg/mL), the average change in Clinical Dementia Rating Sum of Boxes (CDR-SB) was -1.11, indicating significant clinical improvement [6][7] - The mean change in the Alzheimer's Disease Cooperative Study — Clinical Global Impression of Change (ADCS-CGIC) score also demonstrated a greater effect at lower pTau181 levels [7][8] Future Plans - The company plans to initiate a global Phase 3 trial in the second half of 2026, focusing on patients with DLB enriched for those without AD co-pathology [16] - The planned trial will utilize a pTau181 cut-off level of <21 pg/mL, estimated to include 80% to 90% of patients without AD co-pathology [8][16]