BOSTON, July 14, 2026
CervoMed presented new clinical, plasma biomarker, pharmacokinetic, and imaging analyses at the Alzheimer’s Association International Conference (AAIC) 2026, providing additional evidence supporting the development of neflamapimod for Dementia with Lewy Bodies (DLB). The findings reinforce treatment benefits observed in patients with “pure” DLB, demonstrate durable effects on brain structure and connectivity, and support selection of a 50 mg three-times-daily (TID) dose for the company’s planned Phase 3 trial.
New Analyses Strengthen Evidence in Patients Without Alzheimer’s Co-Pathology
Updated analyses from the 159-patient Phase 2b RewinD-LB trial indicated that treatment benefits were most pronounced in patients without Alzheimer’s disease co-pathology, identified by lower plasma pTau181 levels. Investigators also found that patients achieving higher plasma concentrations of neflamapimod experienced greater slowing of disease progression, with improvements on the Clinical Dementia Rating–Sum of Boxes (CDR-SB) compared with placebo. The findings support the patient selection strategy and dosing approach agreed upon with regulatory agencies for the planned global Phase 3 study.
MRI and Biomarker Findings Demonstrate Disease-Modifying Potential
Imaging analyses showed that neflamapimod slowed basal forebrain atrophy and increased functional connectivity between the basal forebrain and the brain’s default mode network compared with placebo. These MRI findings suggest the investigational therapy may influence key neurodegenerative processes underlying DLB rather than only treating symptoms. Additional pharmacokinetic analyses identified a plasma drug concentration threshold associated with clinical and biomarker improvements, further supporting the planned 50 mg TID regimen expected to achieve therapeutic exposure in approximately 90% of patients.
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Additional Phase 2 Study Supports Safety and Future Phase 3 Development
A separate Phase 2 study evaluating an 80 mg twice-daily (BID) dose of neflamapimod met its primary objectives for safety, tolerability, and pharmacokinetics in patients with DLB, with no new safety concerns identified over 24 weeks. Exploratory assessments also suggested stabilization of executive function, global cognition, functional outcomes, and neuropsychiatric symptoms. CervoMed stated that the combined clinical, biomarker, pharmacokinetic, and imaging data strengthen confidence in neflamapimod’s disease-modifying potential and provide important guidance for advancing the therapy into Phase 3 development for patients with Dementia with Lewy Bodies.
Source: CervoMed press release
