CervoMed Inc. (NASDAQ: CRVO) announced topline data from its Phase 2b RewinD-LB clinical trial evaluating neflamapimod for the treatment of patients with dementia with Lewy bodies (DLB). The trial, a randomized, 16-week, double-blind, placebo-controlled study, did not meet statistical significance for its primary endpoint, change in the Clinical Dementia Rating Sum of Boxes (CDR-SB), or any key secondary endpoints. These included the Timed Up and Go (TUG) test, a Neuropsychological Test Battery (NTD), and the Clinician’s Global Impression of Change (CGIC).
Lower Than Expected Drug Concentrations
An initial analysis indicated that target plasma drug concentrations were not achieved during the double-blind phase of the trial, potentially influencing the results. According to CervoMed, retrospective analysis suggested that lower-than-expected bioavailability may be related primarily to the age of the drug batch utilized during the double-blind phase of the study.
"Obviously, we are disappointed with these results, particularly given our prior clinical experience with neflamapimod in patients with early-stage DLB, and we are investigating the reasons for the lower-than-expected plasma drug concentrations," said John Alam, MD, Chief Executive Officer of CervoMed.
Next Steps for CervoMed
CervoMed is currently analyzing the clinical and pharmacokinetic data from the trial to better understand the outcome and potential future development paths for neflamapimod. Data from the first 16 weeks of the open-label extension (OLE) phase of the RewinD-LB trial are expected in late Q2 2025. These data will include results from participants who received capsules from a more recently manufactured batch of neflamapimod, which pharmacokinetic data suggests achieved targeted mean plasma concentrations.
The company has paused all preparations for its previously planned Phase 3 trial in early-stage DLB until the full analysis is complete.
Safety and Tolerability
In the RewinD-LB Phase 2b trial, neflamapimod demonstrated a favorable safety and tolerability profile consistent with prior clinical studies, with no new safety signals identified.
About the RewinD-LB Trial
The RewinD-LB trial enrolled 159 participants with early-stage DLB across 43 sites in the United States, the United Kingdom, and the Netherlands. The trial was funded by a $21.3 million grant from the National Institutes of Health’s National Institute on Aging.
About Dementia with Lewy Bodies
DLB is the third most common degenerative brain disease, affecting approximately 700,000 individuals in both the U.S. and the European Union. It is characterized by the accumulation of Lewy bodies, protein deposits, in the brain's nerve cells, leading to cognitive and motor function decline. There are currently no FDA or EMA-approved treatments specifically for DLB.
