CervoMed Inc. (NASDAQ: CRVO) announced key findings regarding neflamapimod's potential in treating dementia with Lewy bodies (DLB) at the Clinical Trials on Alzheimer's Disease Conference (CTAD). The presentations highlighted a significant reduction in plasma GFAP levels (p=0.015 vs placebo) in Phase 2a trials, indicating reduced neurodegenerative disease activity. The ongoing RewinD-LB Phase 2b study has successfully enrolled DLB patients without tau pathology, optimizing the potential treatment effect. Topline results are expected in December.
Biomarker Data and Clinical Activity
Data from the AscenD-LB Phase 2a trial confirmed that plasma glial fibrillary acidic protein (GFAP) is a robust measure of neurodegenerative disease activity in DLB. Neflamapimod treatment previously led to a significant reduction in plasma GFAP levels (p=0.015 versus placebo), and these reductions were associated with an improvement in clinical outcomes. These findings suggest that neflamapimod reduces neurodegenerative disease activity in the basal forebrain cholinergic system, mediating its clinical activity.
RewinD-LB Phase 2b Study Design and Patient Population
The RewinD-LB Phase 2b clinical study successfully enrolled a DLB patient population optimized to show the treatment effect of neflamapimod when topline data are reported in December. By exclusively enrolling patients without biomarker evidence of tau pathology, the sample size of RewinD-LB provides high statistical power to detect a statistically significant and clinically meaningful difference between neflamapimod and placebo. The study's sample size of 80 patients per arm provides greater than 95%, approaching 100% statistical power for meeting its primary endpoint, change in CDR-SB in neflamapimod-treated patients compared to placebo.
Market Opportunity and Unmet Need
DLB affects over 1.4 million patients in the U.S. and EU, and there are currently no approved treatments. Positive results from the RewinD-LB Phase 2b trial could position neflamapimod as a first-in-class therapy for this significant unmet medical need.
Executive Commentary
"DLB is a rapidly debilitating condition affecting over 1.4 million patients in the U.S. and EU that has no approved treatment," said John Alam, MD, Chief Executive Officer of CervoMed. "As we approach the December topline results for our innovative proof-of-concept RewinD-LB Phase 2b clinical trial of neflamapimod, 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."
