CervoMed announced positive 16-week results from the extension phase of its Phase 2b RewinD-LB study of neflamapimod for dementia with Lewy bodies (DLB). Neflamapimod slowed clinical progression compared to controls, measured by the Clinical Dementia Rating Sum of Boxes (CDR-SB) and Clinical Global Impression of Change (CGIC), and was linked to fewer falls. New data also suggests improvements in cognitive fluctuations and working memory.
These findings are particularly important because they offer potential hope for DLB patients, a population with limited treatment options. The observed improvements in CDR-SB exceed the threshold considered clinically meaningful, suggesting a real-world impact on patients’ daily lives. The reduced fall incidence further enhances the potential value of neflamapimod, as falls are a significant concern for this patient population. Demonstrating efficacy in a “pure” DLB population (excluding patients with Alzheimer’s diseaseAlzheimer’s disease co-pathology) is strategically important, as this clarifies the drug’s effect and potential target population.
The study involved 149 participants who completed the initial 16-week double-blind phase and entered the extension phase where all received neflamapimod. A key aspect of the study involved comparing a new batch of capsules achieving target plasma drug concentrations (New Capsules) with the original batch which did not (Old Capsules, acting as a control). The New Capsules demonstrated a statistically significant improvement on the CDR-SB compared to both Old Capsules and placebo. Improvements were also observed on other endpoints including ADCS-CGIC, Dementia Cognitive Fluctuation Scale, and International Shopping List Test-Recognition. Both Old and New Capsules showed similar safety and tolerability profiles. The study is primarily funded by a $21.3 million grant from the National Institute on Aging.
These positive results pave the way for CervoMed to potentially advance neflamapimod to Phase 3 trials. Further data from the ongoing 32-week extension phase will be crucial to finalize these plans and discussions with regulatory authorities. The positive data strengthens the possibility of neflamapimod becoming a valuable treatment option for DLB, addressing an unmet medical need.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
