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SEC filingCervoMed announced Phase 2b RewinD-LB trial MRI data at 2026 AAN showing neflamapimod increased basal forebrain volume and functional connectivity in DLB patients.
CervoMed presented novel MRI data from the RewinD-LB Phase 2b trial at the 2026 AAN Annual Meeting, providing the first placebo-controlled evidence that neflamapimod increases basal forebrain (BF) volume and enhances functional connectivity in dementia with Lewy bodies (DLB) patients. At week 16, neflamapimod-treated patients (n=8) showed a statistically significant increase in right BF volume (+10.9 ± 7.3 mm³, p=0.022 vs placebo) compared to placebo (n=10, -13.3 ± 6 mm³), equating to a 3.5% gain versus a 4.2% loss (p=0.028). This right-sided effect aligns with regions most impacted in Lewy body disorders. During the 32-week extension (n=16 neflamapimod), right BF volume remained stable (+1.9 ± 3.8 mm³), and static functional connectivity to the default mode network rose 46% (p=0.014, 95% CI 17.4-69.8%), inversely correlating with CDR-SB improvements (p=0.027, r²=0.43). These findings, validated by blinded analysis at Amsterdam UMC, support neflamapimod's mechanism targeting BF cholinergic dysfunction, consistent with prior preclinical and clinical data including biomarker reductions. CEO Dr. John Alam highlighted this as strong evidence of disease modification, reinforcing prior cognitive/functional benefits and utility of BF MRI as a biomarker. The company plans a pivotal Phase 3 trial in DLB patients without AD co-pathology in H2 2026, subject to financing, positioning neflamapimod as a potential first approved DLB therapy amid no current U.S./EU treatments.