CervoMed's Neflamapimod Advances in DLB and ALS Clinical Programs

CervoMed Inc. is advancing its investigational drug neflamapimod in multiple neurodegenerative disease programs, with new clinical data in dementia with Lewy bodies (DLB) and inclusion in a UK platform trial for amyotrophic lateral sclerosis (ALS). The company will present new MRI analyses from its Phase 2b RewinD-LB clinical trial in DLB, demonstrating neflamapimod's potential positive impact on basal forebrain atrophy and functional connectivity.

The clinical update includes new findings from an analysis of structural and functional MRI exams from patients in the Phase 2b RewinD-LB clinical trial, which evaluated the impact of neflamapimod treatment on basal forebrain atrophy – a structural change that has been correlated with cognitive decline in DLB in natural history studies. The analysis provides preliminary evidence that neflamapimod may reduce basal forebrain atrophy in DLB, supports MRI as a tool to assess treatment effects in future DLB studies, and reinforces the potential of neflamapimod to slow disease progression by acting on the underlying disease biology.

Additional data from this first ever MRI analysis of DLB patients treated with neflamapimod will be presented later this month in a poster session at the 2026 American Academy of Neurology Annual Meeting. The company has also finalized its Phase 3 trial design in DLB and achieved alignment with global regulatory authorities on the planned neflamapimod Phase 3 trial.

Separately, neflamapimod has been selected for inclusion in EXPERTS-ALS, a platform funded by the United Kingdom National Institute for Health and Care Research and leading motor neuron disease charities that facilitates rapid testing of potential treatments for amyotrophic lateral sclerosis. This will be the first evaluation of neflamapimod in ALS, with the first person with ALS expected to be dosed by the end of 2026.

The randomized, multicenter, open-label trial will measure neurofilament light chain (NfL) in blood, with initial evaluation targeting approximately 35 patients for 18–24 weeks and potential expansion to 80. Trial costs in EXPERTS-ALS are funded by the UK National Institute for Health and Care Research and leading motor neuron disease charities, reducing CervoMed's cost exposure.

Neflamapimod is an investigational, orally administered small-molecule drug that readily crosses the blood-brain barrier and selectively inhibits the alpha isoform of p38 MAP kinase, a key driver of neuroinflammation and synaptic dysfunction. By targeting the critical disease processes underlying degenerative disorders of the brain, neflamapimod has the potential to reverse synaptic dysfunction, improve neuron health, and slow or prevent disease progression.

In non-clinical studies, neflamapimod restored synaptic function within the basal forebrain cholinergic system, the brain region most affected in DLB. Across Phase 1 and 2 clinical trials involving more than 800 participants, the drug has been generally well tolerated and demonstrated consistent signals of efficacy. In the 91-patient Phase 2a AscenD-LB trial, neflamapimod significantly improved dementia severity and functional mobility in patients with DLB.

Results from the 159-patient Phase 2b RewinD-LB trial, a 16-week randomized, double-blind, placebo-controlled trial followed by a 32-week open-label extension, further supported neflamapimod's potential to deliver meaningful clinical benefit, improving both cognitive and functional outcomes and showing a positive effect on a key blood biomarker of neurodegeneration during the extension phase.

Dementia with Lewy bodies is the second most common progressive dementia, affecting millions worldwide, and has no approved treatments in the United States or European Union. In the absence of Alzheimer's disease co-pathology, disease expression and progression in DLB is largely driven by synaptic dysfunction, rather than neurodegeneration and neuronal loss.