CervoMed Announces Alignment with FDA on Registration Path for Neflamapimod in Dementia with Lewy Bodies

Core Viewpoint - CervoMed has received FDA feedback that aligns with its proposed Phase 3 clinical trial design for neflamapimod, a drug targeting dementia with Lewy bodies (DLB), marking a significant step towards a potential New Drug Application submission [1][4] Phase 3 Trial Design and Regulatory Alignment - The Phase 3 trial will be a global, randomized, double-blind, placebo-controlled study involving approximately 300 DLB patients, set to begin in the second half of 2026 [2] - Patients with historical evidence of Alzheimer's disease will be excluded, and further enrichment will be achieved through a validated blood plasma test [2] - Participants will be randomized 1:1 to receive either neflamapimod or placebo for 32 weeks, followed by an additional 48-week extension with neflamapimod only [2] Primary and Secondary Endpoints - The primary endpoint will be the change in the Clinical Dementia Rating-Sum of Boxes (CDR-SB), consistent with the recently completed Phase 2b trial [3] - Secondary endpoints will include the percentage of participants with a greater than 1.5-point increase in CDR-SB and other established cognitive and motor function measures [3] Advancing Toward Registration - CervoMed's CEO expressed satisfaction with the FDA's alignment on the trial design, emphasizing the potential of neflamapimod to transform care for DLB patients [4] - The company anticipates feedback from other global regulators and plans to provide further details on the Phase 3 trial design in early 2026 [4] About Dementia with Lewy Bodies - DLB is the second most common progressive dementia after Alzheimer's disease, affecting millions globally, with no approved treatments available in the U.S. or EU [5] About Neflamapimod - Neflamapimod is an investigational oral drug that inhibits a key enzyme involved in neuroinflammation and synaptic dysfunction, showing promise in restoring synaptic function and improving neuron health [6][7] - Clinical trials have demonstrated that neflamapimod is generally well tolerated and has shown efficacy in improving dementia severity and functional mobility in DLB patients [8]