CervoMed (NASDAQ: CRVO) will share 32-week primary endpoint results from the extension phase of its Phase 2b RewinD-LB study of neflamapimod for dementia with Lewy bodies (DLB) on July 28, 2025. These results follow late-breaking presentations at the Alzheimer’s Association International Conference (AAIC) 2025. The company will host a conference call and webcast at 8:00 AM ET on the same day to discuss the findings.
These results are crucial for the DLB patient community, as there are currently no approved disease-modifying therapies. Positive data could signal a potential breakthrough in treating this debilitating condition, offering new hope for patients and their families. The exclusion of patients with Alzheimer’s disease co-pathology from the RewinD-LB study provides a cleaner assessment of neflamapimod’s efficacy specifically in DLB, addressing a key challenge in developing targeted therapies for this complex disease.
The RewinD-LB study is a randomized, double-blind, placebo-controlled trial involving 159 DLB patients. It includes a 16-week initial phase followed by a 32-week extension phase where all participants receive neflamapimod. The primary endpoint is the change in the Clinical Dementia Rating – Sum of Boxes, with secondary endpoints including the Alzheimer’s Disease Cooperative Study – CGIC, the Timed Up and Go test, and a cognitive test battery. The study is primarily funded by a $21.3 million grant from the National Institute on Aging.
The upcoming data release has significant implications for CervoMed and the DLB landscape. Positive 32-week data could accelerate the development of neflamapimod, potentially leading to a pivotal Phase 3 trial. This could position CervoMed as a leader in the DLB therapeutic space, attracting further investment and partnerships. Conversely, negative or inconclusive results would require a reassessment of the drug’s development strategy.
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.