CervoMed Inc. announced key findings regarding neflamapimod's potential as a treatment for dementia with Lewy bodies (DLB) at the Clinical Trials on Alzheimer’s Disease Conference (CTAD). The data, derived from the AscenD-LB Phase 2a trial and insights into the RewinD-LB Phase 2b clinical study, suggest that neflamapimod could address the unmet need in DLB, a condition affecting over 1.4 million individuals in the U.S. and EU with no approved treatments.
Biomarker Analysis Supports Neflamapimod's Mechanism of Action
Data from the AscenD-LB Phase 2a trial confirmed 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 improvements in clinical outcomes. According to CervoMed, this indicates that neflamapimod reduces neurodegenerative disease activity in the basal forebrain cholinergic system, and its clinical activity is mediated by that effect.
Patient Selection Strategy for RewinD-LB Phase 2b Trial
The RewinD-LB Phase 2b clinical study successfully enrolled a DLB patient population optimized to demonstrate the treatment effect of neflamapimod. The trial focused on patients without biomarker evidence of tau pathology. CervoMed believes that excluding patients with high levels of tau pathology focuses the clinical trial on patients with the least amounts of fixed, irreversible neurodegeneration, thereby increasing the magnitude of the clinical effect and probability of success. The clinical profile of the patients enrolled into RewinD-LB has substantial clinical disease burden and is similar to that in the patients without biomarker evidence of tau pathology group in the Phase 2a study, the group that showed the highest magnitude treatment response.
Statistical Power of RewinD-LB Enhanced by Patient Selection
By exclusively enrolling patients without biomarker evidence of tau pathology, the RewinD-LB trial is expected to have greater than 95%, approaching 100% statistical power for meeting its primary endpoint, change in CDR-SB in neflamapimod-treated patients compared to placebo. The sample size for RewinD-LB of 80 per patients per arm was originally chosen to have sufficient statistical power to detect the expected treatment effect in a population including patients both with and without biomarker evidence of tau pathology.
CervoMed's Perspective
John Alam, MD, Chief Executive Officer of CervoMed, stated, “We are excited to share additional results on the effect of neflamapimod treatment on an important biomarker of DLB neurodegenerative disease activity, as well as the baseline characteristics of the patients enrolled into the Phase 2b study. Taken together, we believe the findings further increase the probability of success of the clinical trial.”
Topline data from the RewinD-LB Phase 2b clinical trial are anticipated in December.
