CervoMed Inc. announced completion of a Phase 1 healthy volunteer study evaluating pharmacokinetics of a new stable crystal form of neflamapimod and selected a 50mg TID dosing regimen for its planned Phase 3 trial in dementia with Lewy bodies (DLB), targeting plasma concentrations matching the clinically active DP Batch B from the Phase 2b RewinD-LB trial extension.
Key takeaways
Completed Phase 1 PK study with stable crystal form of neflamapimod using new controlled manufacturing process
Selected 50mg TID dosing for planned Phase 3 DLB trial to achieve plasma concentrations of DP Batch B
PK profile of 40mg stable crystal form largely overlaps with 40mg DP Batch B from Phase 2b extension
Plans to initiate global Phase 3 DLB trial in second half of 2026, subject to funding
New process addresses prior polymorph conversion and bioavailability issues with DP Batch A