CervoMed Announces Positive 16-Week Extension Results For Neflamapimod In Dementia With Lewy Bodies

CervoMed Inc. announced positive 16-week results from the extension phase of its Phase 2b RewinD-LB trial for neflamapimod in dementia with Lewy bodies (DLB). The trial initially enrolled 159 participants in a 16-week, double-blind, placebo-controlled phase, with 152 completing it. Of these, 149 patients entered the open-label extension phase, where all participants received neflamapimod. 

James E. Galvin, MD, MPH, Professor of Neurology at the Miller School of Medicine in Miami, Co-Principal Investigator of the RewinD-LB study and member of the Board at the Lewy Body Dementia Association (LBDA), said, “This is a great day for patients and families impacted by DLB, as well as the DLB clinical community. The magnitude of the effect demonstrated on the CDR-SB and the CGIC, both clinically meaningful endpoints, as well as the apparent beneficial effect on the incidence of participant, falls, suggests that neflamapimod has the potential to fundamentally change the disease course of DLB and our approach to treating the disease.” 

He also commented, “To date, there is not a single drug approved in the U.S. for the management of DLB. My colleagues in the DLB clinical community and I look forward to working with CervoMed and regulatory authorities to advance neflamapimod through phase 3 and the regulatory approval process.”

“As presented at the recent International Lewy Body Dementia Conference, 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. Further, the consistency and magnitude of the clinical effect of neflamapimod on the CDR-SB are similar to our Phase 2a study results, and we believe demonstrate proof-of-concept for neflamapimod as a potential treatment for dementia with Lewy bodies. 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. 

The study was blinded to whether participants continued receiving the same batch of capsules or a new batch. Completion rates for the 16-week extension phase were high, with 87.3% of participants who continued with the old batch of capsules completing treatment, compared to 91.5% of those who received the new batch.

John-Paul Taylor, MBBS(Hons) MRCPsych PhD, Professor of Translational Dementia Research at Newcastle University, United Kingdom (UK) and the principal investigator for the UK, commented, “The results from the extension phase of the RewinD-LB study are highly persuasive. It is rare in dementia clinical research to see results with the magnitude of effect and statistical strength as was seen on the CDR-SB. At the same time, the findings are similar to what was seen in the Phase 2a clinical study, and I believe are the result of having utilized a targeted therapy such as neflamapimod as well as aligning the therapy with a DLB patient population that is well suited to respond to its mechanism of action.”