CervoMed Inc. announced that data from the AscenD-LB Phase 2a trial evaluating treatment with neflamapimod in patients with dementia with Lewy bodies (DLB) were published online in the Journal of Prevention of Alzheimer's Disease (JPAD). The published manuscript titled "Phase 2a learnings incorporated into RewinD-LB, a Phase 2b clinical trial of neflamapimod In dementia with Lewy bodies," is available online. Results published for the first time in the JPAD manuscript are as follows: An integrated summary of the effects of neflamapimOD 40mg three-times-a-day (TID) compared to placebo in the AscenD-LB phase 2a clinical trial across all endpoints in (1) the overall patient population that contains a mixed population of patients with DLB with evidence of AD (i.e., with pre-treatment plasma ptau181 level above the pre-defined cutoff for AD co-pathology) and patients with pure DLB (i.e., with Pre-treatment plasma ptau181 below cutoff); and (2) in the pure DLB patient population alone.

As evident in the table, compared to the response in the overall patient population, the magnitude of the neflamapimod treatment effect vs. placebo is substantially higher in the pure DLB patient populations. In addition, the pure DLB patients show significant improvement on working memory, assessed by the International Shopping List Test (ISLT) recognition, that is not evident in the overall patient population.

Difference between neflamapimod 40mg TID and placebo from mixed model for repeated measures (MMRM) analysis. Improvement reflected by negative sign for CDR-SB and TUG and positive sign for other measures. Abbreviations: NFMD ?

neflamapimod; NTB ? Neuropsychological Test Battery; CDR-SB ? Clinical Dementia Rating Sum of Boxes; TUG ?

Time Up and Go test; ISLT ? International Shopping List Test; RECOG ?Recognition EEG results from the AscenD-LB Phase 2a trial, which demonstrated that neflamapimod 40mg TID treatment led to improvement (p=0.01 vs. placebo TID) in beta functional connectivity assessed by EEG.

Deficits in beta band functional connectivity may be a key differentiator between DLB and Alzheimer?s disease (AD). In a prior Phase 2a study in AD, neflamapimod treatment led to an increased volume and functional connectivity of the basal forebrain by MRI. Specifically, the analysis demonstrated that the volume of the nucleus basalis of meynert (NbM, the major cholinergic neuronal cluster in the basal forebrain) was higher at the end of 12 weeks neflamapimod treatment (EOT, mean 3.1% higher vs.

baseline, p=0.03). Treatment with neflamapimod was also associated with higher functional dynamic connectivity between the NbM and deep grey matter (DGM) at EOT (mean 11% higher vs. baseline, p=0.04).

Key learnings from AscenD-LB have been incorporated into the ongoing RewinD-LB Phase 2b trial of neflamapimod, including the use of a single dose regimen of neflamapimod 40mg TID, enrolling patients with pure DLB and selecting CDR-SB as the primary endpoint. To further evaluate potential effects on the underlying disease process, structural and functional MRI will be evaluated in a 40-patient subgroup to assess treatment effects on atrophy of the basal forebrain, as well its functional connectivity.