CervoMed to Host Virtual KOL Event on Neflamapimod for Lewy Body Dementia on July 23, 2024

15 July 2024
CervoMed Inc. has announced that its Phase 2b RewinD-LB trial for neflamapimod, aimed at treating dementia with Lewy bodies (DLB), has reached full enrollment, with topline data expected by December 2024. This announcement highlights a significant milestone in the development of potential treatments for age-related neurological disorders by the Boston-based clinical-stage company.

The company plans to host a virtual Key Opinion Leader (KOL) event on July 23, 2024, at 10:00 AM ET. This event will feature discussions led by distinguished experts in the field. John-Paul Taylor, a professor at Newcastle University, will address the unmet needs in DLB and the role of the cholinergic system's integrity loss in the disease. Ralph A. Nixon from New York University Grossman School of Medicine will present mechanistic and preclinical data on neflamapimod, an oral p38α inhibitor, which targets the underlying molecular mechanisms of degeneration and dysfunction in the basal forebrain cholinergic system.

The agenda will cover several key topics:
- An overview of the DLB disease state, current treatment landscape, and unmet needs,
- The role of the basal forebrain cholinergic system in DLB progression,
- Neflamapimod's mechanism of action and its potential to reverse disease progression,
- The significance of plasma phosphorylated tau in selecting patients for DLB clinical trials,
- Detailed insights into the design of CervoMed’s Phase 2b RewinD-LB trial, which aims to pave a clear path to market approval if successful.

John-Paul Taylor, a renowned expert, has an extensive background in dementia research, particularly in DLB. He has published over 200 peer-reviewed articles and led significant research efforts focusing on neuroimaging and neurophysiological approaches to understanding symptoms and developing management strategies for Lewy body diseases.

Ralph A. Nixon, another prominent figure, has also made substantial contributions to understanding neurodegenerative diseases. His research focuses on the biological mechanisms of protein clearance and molecular defects related to Alzheimer's disease and other dementias. He has over 300 scientific publications and numerous patents and has received several prestigious awards for his work.

The RewinD-LB Phase 2b study is a randomized, 16-week, double-blind, placebo-controlled clinical trial evaluating oral neflamapimod (40mg TID) in up to 160 patients with very mild or mild DLB. Following the initial study period, patients can continue with an open-label neflamapimod treatment for an additional 32 weeks. The study excludes patients with Alzheimer’s Disease-related co-pathology, assessed via a blood biomarker (plasma ptau181).

The primary endpoint for the trial is the change in the Clinical Dementia Rating Sum of Boxes, with secondary endpoints including the Timed Up and Go test, a cognitive test battery, and the Clinician’s Global Impression of Change. Funded by a $21 million grant from the National Institutes of Health’s National Institute on Aging, the study is being conducted across 43 sites in the US, UK, and the Netherlands.

CervoMed Inc. is dedicated to developing treatments for neurological disorders, with neflamapimod being a promising candidate currently under evaluation. This investigational drug aims to treat synaptic dysfunction, a reversible aspect of neurodegenerative processes in DLB and other neurological disorders.

The virtual KOL event will also include a live question and answer session moderated by John Alam, CEO of CervoMed, following the formal presentation. Attendees are required to register in advance, and a replay will be available on CervoMed’s website for those unable to attend.

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