Dementia drug neflamapimod shows positive phase 2b trial results

CervoMed’s therapy demonstrates significant improvement in patients

CervoMed has announced positive results from the extension phase 2b RewinD-LB study of neflamapimod for dementia with Lewy bodies (DLB).

A new batch of neflamapimod capsules led to increased plasma drug concentrations and demonstrated improvement on the Clinical Dementia Rating Sum of Boxes (CDR-SB). Improvement was also shown on the Alzheimer’s Disease Cooperative Study – Clinical Global Impression of Change (CGIC).

Compared to old capsules or placebo, a lower incidence of falls was observed in participants receiving the new drug batch. James E. Galvin, MD, MPH, said: “This is a great day for patients and families impacted by DLB, as well as the DLB clinical community.” He added that neflamapimod has the potential to fundamentally change the disease course.

John Alam, MD, CEO of CervoMed, said: “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 utilised in that phase of the trial delivered lower than expected plasma drug concentrations and effectively underdosed participants.”

He stated the new capsules led to higher drug concentration levels and improvements.

John-Paul Taylor, MBBS(hons) MRCPsych PhD, said: “The results from the extension phase of the RewinD-LB study are highly persuasive.”

He added that the findings are similar to the phase 2a clinical study results. CervoMed will complete the 32-week extension p and engage with regulatory authorities to discuss phase 3 plans.