CervoMed Announces Presentation at AAIC 2024 on Plasma Biomarker Data That Are Consistent with Neflamapimod Impacting the Underlying Disease Process in Patients with Dementia with Lewy bodies (DLB)

Core Insights - CervoMed Inc. announced significant findings from the AscenD-LB Phase 2a trial, indicating that plasma GFAP levels correlate with dementia severity in patients with dementia with Lewy bodies (DLB) and that neflamapimod treatment significantly reduces plasma GFAP levels compared to placebo [1][2][3] Group 1: Trial Results - The AscenD-LB Phase 2a trial demonstrated that neflamapimod treatment led to a significant reduction in plasma GFAP levels in DLB patients, which was associated with improvements in clinical outcomes measured by the Clinical Dementia Rating Sum of Boxes (CDR-SB) [1][2] - In early-stage DLB patients, the placebo group experienced a mean increase of 14.1 pg/mL in plasma GFAP, while the neflamapimod group saw a mean reduction of 10.6 pg/mL, with a statistically significant difference (p=0.04) [3] - In advanced DLB patients, the neflamapimod treatment resulted in a mean reduction of 14.0 pg/mL in plasma GFAP, although the difference compared to placebo was not statistically significant [3] Group 2: Biomarker Significance - Plasma GFAP has been validated as a biomarker for evaluating therapeutic effects on DLB-specific disease processes, with baseline GFAP levels correlating with dementia severity [2][4] - Recent studies indicate that plasma GFAP is elevated in prodromal DLB patients compared to healthy controls, suggesting its potential as a marker for early disease processes [4][5] Group 3: Ongoing Studies - The RewinD-LB Phase 2b study is currently underway, evaluating the efficacy of neflamapimod in up to 160 patients with very mild or mild DLB, with topline data expected in December 2024 [6] - The study is funded by a $21 million grant from the National Institutes of Health's National Institute on Aging and aims to assess changes in CDR-SB as the primary endpoint [6]