Core Insights - CervoMed Inc. has reported significant improvements in the Phase 2b RewinD-LB trial for neflamapimod, particularly in participants with low likelihood of Alzheimer's disease co-pathology, as measured by the Clinical Dementia Rating Sum of Boxes (CDR-SB) [1][2][3] - The company anticipates feedback from the U.S. Food and Drug Administration (FDA) regarding the Phase 3 trial design in Q4 2025 [1][2] Trial Results - The RewinD-LB trial included a 16-week placebo-controlled phase followed by a 32-week extension phase, with a focus on participants whose plasma ptau181 levels were below 21 pg/mL, indicating a low likelihood of Alzheimer's disease co-pathology [3][4][8] - In the initial phase, there was a trend towards improvement in CDR-SB for the drug product batch that did not achieve targeted plasma concentrations compared to placebo [6] - The extension phase showed significant improvement in CDR-SB and other cognitive measures for participants receiving the new drug product batch that achieved targeted plasma concentrations [6][10] Biomarker Analysis - Neflamapimod significantly reduced plasma GFAP levels, a biomarker of neurodegeneration, in participants who received the new drug product batch for 12 or more weeks [7][11] - In participants with low likelihood of Alzheimer's co-pathology, changes in plasma GFAP levels correlated significantly with changes in CDR-SB scores, indicating a relationship between biomarker effects and clinical outcomes [11] Company Background - CervoMed is focused on developing treatments for age-related neurologic disorders, with neflamapimod being an investigational small molecule aimed at treating synaptic dysfunction in dementia with Lewy bodies [9]