CervoMed Inc. (NASDAQ: CRVO) has announced key findings regarding neflamapimod, an investigational treatment for dementia with Lewy bodies (DLB), presented at the Clinical Trials on Alzheimer’s Disease Conference (CTAD). The data suggest that neflamapimod may improve clinical outcomes by targeting neurodegenerative activity in the basal forebrain cholinergic system.
AscenD-LB Phase 2a Trial Results
Data from the AscenD-LB Phase 2a trial in DLB confirms that plasma glial fibrillary acidic protein (GFAP) is a reliable measure of neurodegenerative disease activity in DLB. Notably, neflamapimod treatment led to a significant reduction in plasma GFAP levels (p=0.015 versus placebo), and these reductions correlated with improved clinical outcomes. This suggests that neflamapimod's clinical activity is mediated by reducing neurodegenerative disease activity in the basal forebrain cholinergic system.
RewinD-LB Phase 2b Clinical Study
The RewinD-LB Phase 2b clinical study has successfully enrolled a DLB patient population optimized to show the treatment effect of neflamapimod. The study design focuses on patients without biomarker evidence of tau pathology, aiming to increase the probability of observing a significant clinical effect. Topline data from this trial are expected in December.
Targeting the Right Patient Population
According to John Alam, MD, Chief Executive Officer of CervoMed, DLB affects over 1.4 million patients in the U.S. and EU and currently has no approved treatments. CervoMed's approach involves utilizing imaging and blood testing to exclude patients with high levels of tau pathology, focusing clinical trials on patients with less irreversible neurodegeneration. This strategy aims to enhance the magnitude of the clinical effect and increase the probability of success.
Statistical Power and Clinical Significance
The RewinD-LB trial, with 80 patients per arm, was initially designed to detect the expected treatment effect in a population including patients both with and without biomarker evidence of tau pathology. By exclusively enrolling patients without tau pathology, the study now has greater than 95% statistical power to meet its primary endpoint, which is the change in Clinical Dementia Rating Sum of Boxes (CDR-SB) in neflamapimod-treated patients compared to placebo.
