Core Insights - CervoMed Inc. announced positive results from the first 16 weeks of the extension phase of the Phase 2b RewinD-LB study of neflamapimod for dementia with Lewy bodies (DLB), showing significant improvements in clinical measures compared to both old capsules and placebo [1][2][10] Study Overview - The RewinD-LB study included 159 participants in the initial phase, with 152 completing it and 149 entering the extension phase where all received neflamapimod [3][4] - The study is funded by a $21.3 million grant from the National Institutes of Health's National Institute on Aging [14] Clinical Results - The new batch of neflamapimod capsules led to increased plasma drug concentrations, with a mean trough concentration of 5.1 ng/mL compared to 4.0 ng/mL for old capsules [8] - Significant improvement was observed in the Clinical Dementia Rating Sum of Boxes (CDR-SB) with a difference of -0.73 (p<0.001) between new and old capsules [10] - The Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (CGIC) showed improved scores with new capsules (4.02 vs. 4.46, p=0.035) [10] Safety and Tolerability - Both old and new capsules demonstrated comparable tolerability profiles, with no new safety signals identified during the extension phase [10] - The incidence of falls was lower in participants receiving new capsules (7.4% vs. 14.5% for old capsules, p=0.025) [10] Future Plans - CervoMed plans to engage with regulatory authorities to discuss advancing neflamapimod through Phase 3 and the regulatory approval process [2][10] - The results from the extension phase will be presented at the International Conference on Alzheimer's and Parkinson's Diseases in April 2025 [11]
CervoMed Announces Positive Results from the Extension Phase of its Phase 2b Clinical Study of Neflamapimod in Patients with Dementia with Lewy Bodies