Investigators to Present Clinical Trial Results Showing Neflamapimod Slows Clinical Progression in Dementia with Lewy Bodies in Oral Presentation at AD/PD™ 2025

Core Insights - Neflamapimod has shown a clinically meaningful effect in slowing the progression of dementia with Lewy bodies (DLB) during the Extension phase of the RewinD-LB clinical study [1][2][3] - The study results will be presented at the AD/PD™ 2025 conference, highlighting improvements in cognitive fluctuations and working memory [1][2] - CervoMed Inc. is focused on developing neflamapimod as a transformative therapy for DLB, with plans for pivotal development following the completion of the study [2][7] Study Overview - The RewinD-LB study involved 159 participants, with 152 completing the initial phase and 149 entering the Extension phase where all received neflamapimod [3][6] - The study is a randomized, double-blind, placebo-controlled trial evaluating neflamapimod (40mg TID) over a total of 48 weeks [6][8] - The primary outcome measure is the change in Clinical Dementia Rating Sum of Boxes (CDR-SB), with secondary endpoints including the Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (CGIC) [6][8] Results and Findings - The New Capsules of neflamapimod achieved target plasma drug concentrations, leading to significant clinical outcomes compared to the Old Capsules and placebo [4][9] - Participants receiving New Capsules showed a mean improvement of 0.73 points in CDR-SB compared to Old Capsules, and 0.81 points in those without Alzheimer's disease co-pathology [9] - The incidence of clinically meaningful worsening was 40% lower in New Capsule recipients compared to Old Capsules, and 62% lower in participants without Alzheimer's co-pathology [9] Safety and Tolerability - Both Old and New Capsules exhibited similar safety and tolerability profiles, with no new safety signals identified during the Extension phase [6][9] - The New Capsules resulted in a lower incidence of falls (4% vs. 15.2% with Old Capsules) during the Extension phase [9] Future Plans - CervoMed aims to complete the full 32-week Extension phase and engage with regulatory authorities to finalize Phase 3 plans for neflamapimod [7]