On 10 December, CervoMed, a clinical-stage company focused on developing treatments for age-related neurologic disorders, announced topline data from its Phase IIb RewinD-LB clinical trial of neflamapimod in people with dementia with Lewy bodies (DLB). The randomised 16-week, double-blind and placebo-controlled trial enrolled 159 participants with early-stage DLB across 43 sites in the US, UK and Netherlands. The trial did not meet statistical significance thresholds for its primary endpoint, a change in the Clinical Dementia Rating Sum of Boxes (CDR-SB), nor did it achieve any of its key secondary endpoints, including the Timed Up and Go (TUG) test, the Neuropsychological Test Battery (NTD) and the Clinician’s Global Impression of Change (CGIC).
Neflamapimod demonstrated a favorable safety and tolerability profile consistent with previous clinical studies, with no new safety signals identified. According to John Alam, Chief Executive Officer of CervoMed, the company is pausing all preparations for the previously planned Phase III trial in early-stage DLB until the full analysis is complete. The full data set from the double-blind phase of the RewinD-LB trial is expected to be available in January 2025. Participants continue to receive neflamapimod during the open-label extension with data anticipated in the second quarter of 2025.