CervoMed (US:CRVO) Globenewswire·2025-12-04 22:00Core Insights - The Phase 2b RewinD-LB trial of neflamapimod showed significant improvements in primary and key secondary outcomes, particularly in patients without Alzheimer's disease (AD) co-pathology [1][2] - Neflamapimod demonstrated a significant reduction in the neurodegeneration biomarker GFAP, indicating its potential to target the underlying mechanisms of dementia with Lewy bodies (DLB) [1][10] - CervoMed plans to initiate a Phase 3 registrational trial for neflamapimod in DLB patients in the second half of 2026 [1][9] Trial Results - The RewinD-LB trial included a randomized phase comparing neflamapimod to placebo, followed by an open-label extension phase [3][7] - In the extension phase, participants receiving a new batch of neflamapimod capsules achieved target plasma concentration levels, leading to significant improvements in clinical outcomes [4][5] - The primary endpoint, CDR-SB, showed a mean change that was 52% lower with the new batch compared to the initial batch, and 82% lower in patients without AD co-pathology [5][10] Safety and Tolerability - Neflamapimod was well-tolerated, with a low treatment discontinuation rate over 48 weeks [6][10] - Discontinuation due to liver enzyme elevation was 2.5% in the initial phase and 1.3% in the extension phase, with all events being reversible [6][10] Company Overview - CervoMed is a clinical-stage company focused on developing treatments for age-related brain disorders, with neflamapimod as its lead candidate [9][11] - The company aims to address critical disease processes underlying degenerative brain disorders through neflamapimod, which inhibits a key enzyme involved in neuroinflammation [9][11] Disease Context - Dementia with Lewy bodies (DLB) is the second most common progressive dementia after Alzheimer's, with no approved treatments available in the U.S. or EU [8][9] - DLB typically progresses more rapidly than Alzheimer's, often requiring nursing-home care within two years of diagnosis [8][9]