CervoMed Announces 32-Week Data from RewinD-LB Trial Extension Phase Showing Neflamapimod's Sustained Effect on Slowing Clinical Progression in Patients with Dementia with Lewy Bodies and Associated Reduction in a Key Plasma Biomarker of Neurodegeneration

Core Insights - CervoMed Inc. announced positive results from the 32-week Extension phase of the Phase 2b RewinD-LB trial, showing that oral neflamapimod led to a 54% risk reduction in clinically significant worsening of dementia symptoms compared to control, improving to 64% for patients with minimal Alzheimer's Disease co-pathology [1][2][11] - The trial results were presented at the Alzheimer's Association International Congress 2025, highlighting the potential of neflamapimod as a treatment for Dementia with Lewy Bodies (DLB) [1][2] Clinical Trial Results - The primary endpoint, Clinical Dementia Rating Sum of Boxes (CDR-SB), showed a significant reduction in disease progression for patients treated with neflamapimod [1][2] - At Week 32, patients receiving neflamapimod demonstrated a statistically significant reduction in plasma levels of glial fibrillary acidic protein (GFAP), indicating a positive effect on neurodegeneration [1][10] - The analysis indicated that patients treated with new capsules of neflamapimod had a statistically significant slower disease progression compared to those treated with older capsules [5][10] Statistical Data - The hazard ratio for patients with ptau181 < 2.4 pg/mL was 0.46 (p=0.0037), and for those with ptau181 < 2.2 pg/mL, it was 0.36 (p=0.0001), indicating a strong correlation between lower ptau181 levels and reduced risk of clinical worsening [4][10] - A mean change in GFAP plasma levels was recorded as -18.4±4.0 pg/mL for all participants and -21.2±4.4 pg/mL for those with ptau181 < 2.2 pg/mL [10] Future Plans - CervoMed is preparing to initiate a Phase 3 trial and plans to meet with the U.S. Food and Drug Administration in Q4 2025 to discuss trial design [2][11] - The company aims to provide a meaningful treatment option for DLB patients, addressing the significant unmet needs in this area [2][11] Company Background - CervoMed is a clinical-stage company focused on developing treatments for age-related neurologic disorders, with neflamapimod being an investigational oral small molecule targeting neurodegenerative processes [12]