On 10 March, CervoMed, a clinical-stage company focused on developing treatments for age-related neurologic disorders, announced results from the extension phase of its Phase IIb RewinD-LB study of neflamapimod for the treatment of dementia with Lewy bodies (DLB). The RewinD-LB is a randomised, 16-week, double-blind and placebo-controlled clinical study evaluating oral neflamapimod in 159 participants with DLB. The study included 43 sites across the United States, the United Kingdom and the Netherlands. Topline results, released in December 2024, showed that the study did not meet statistical significance for its primary endpoint (change in the Clinical Dementia Rating Sum of Boxes, or CDR-SB) or any of its key secondary endpoints. The extension phase of the study offered participants the opportunity to continue receiving neflamapimod treatment for an additional 32 weeks after completing the 16-week initial phase. Of the 159 participants randomised in the initial 16-week phase study, 152 completed it and 149 entered the extension phase, during which all participants received neflamapimod. Of the 149 participants who entered the extension phase, 55 continued on the same batch of capsules (“old capsules”) and 94 participants transitioning to a new batch (“new capsules”).
The results from the first 16 weeks of the extension phase showed that participants who received the new batch of neflamapimod capsules exhibited increased plasma drug concentrations and demonstrated improvements on the primary endpoint of CDR-SB. Additionally, improvement was also observed on one of the key secondary endpoints, the Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (CGIC). Administration of the new capsules led to an improved CGIC score, indicating less worsening with new capsule administration. Safety profiles for both capsule types were comparable, with no new safety concerns identified during the extension phase. However, a lower incidence of falls was seen in participants receiving study drug from the new batch of capsules during the extension phase.
“Our working hypothesis for the failure of neflamapimod during the initial 16 weeks of the study is that the investigational drug capsules utilized in that phase of the trial delivered lower than expected plasma drug concentrations and effectively underdosed participants. Consistent with this hypothesis, the results announced today demonstrate the new batch of capsules led to both higher plasma drug concentration levels and improvements on the metrics used as the primary endpoint and a key secondary endpoint in the initial phase of the study. We are excited to complete the full 32-weeks of the extension phase of the study and look forward to engaging with regulatory authorities to discuss finalizing our Phase 3 plans after these additional data are available later this year.” said John Alam, MD, co-principal investigator of the RewinD-LB study and CEO of CervoMed.