CervoMed gets FDA alignment on Phase 3 trial design for neflamapimod in DLB

CervoMed Inc.

FDA aligned on primary endpoint (CDR-SB), patient enrichment strategy, and trial design for ~300 DLB patients.
Enrollment to exclude Alzheimer’s co-pathology via brain imaging, CSF, and plasma ptau181 ≥ 21.0 pg/mL cutoff.
Phase 3 trial planned to start in H2 2026; 32-week double-blind period followed by 48-week open-label extension.
No approved therapies for DLB in US or EU; neflamapimod targets cognitive and functional decline.
Company expects additional global regulatory feedback in coming months; detailed design early 2026.

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