CervoMed Inc. (NASDAQ:CRVO) shares surged 9% in premarket trading on Wednesday after the clinical-stage biopharmaceutical company reported additional positive findings from its Phase 2b RewinD-LB trial, which is testing a potential treatment for dementia with Lewy bodies (DLB).
The company said the new analyses showed that its investigational drug, neflamapimod, delivered notable gains in cognitive performance versus placebo. The improvements were especially pronounced among patients who had a low likelihood of Alzheimer’s disease co-pathology, suggesting the therapy’s strongest effect occurs in this subgroup.
In a key subgroup analysis, participants who switched from placebo to CervoMed’s optimized drug formulation exhibited meaningful improvement on the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB), showing a difference of -1.12 points (p=0.005) compared with their results on placebo.
The trial also revealed that neflamapimod reduced plasma GFAP levels—a biomarker of neurodegeneration—by about 50% in patients with a low likelihood of Alzheimer’s co-pathology. Importantly, these reductions were linked to measurable cognitive improvements, further validating the biomarker as a potential indicator of clinical benefit.
“The significant improvements compared to placebo in change in CDR-SB observed in the within-subject comparison, along with correlated reductions in a key biomarker of neurodegeneration further strengthen our confidence in neflamapimod’s potential as a treatment for DLB,” said John Alam, M.D., Chief Executive Officer of CervoMed.
The study also found that neflamapimod reduced the risk of clinically meaningful disease progression by 67% over a 32-week period in the targeted patient population.
CervoMed said it expects to receive FDA feedback on its Phase 3 trial design later this quarter, noting that the latest results will play an important role in refining and optimizing the upcoming pivotal study.
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