CervoMed Completes Phase 1 Volunteer Trial To Evaluate Pharmacokinetics Of Drug Product Having Only New Stable Crystal Form Of Neflamapimod, Related Updates Regarding Its Planned Phase 3 Trial In Dementia With Lewy Bodies

CervoMed Inc. (CervoMed or the Company) (NASDAQ:CRVO), a clinical-stage biotechnology company developing treatments for age-related brain disorders, today announced that it has successfully completed a Phase 1 healthy volunteer study designed to evaluate the pharmacokinetics (PK) of drug product (DP) containing only a new, stable crystal form of neflamapimod and related updates regarding its planned Phase 3 trial in dementia with Lewy bodies (DLB).

Following its evaluation of the study's results, the Company has selected 50mg of the stable crystal form of neflamapimod three times per day (TID) as the dose and dosing regimen for its planned Phase 3 study in patients with DLB. While the PK profiles of 40mg of DP Batch B and 40mg of the stable crystal form of neflamapimod are largely overlapping, the dose will be increased to 50mg in the Company's planned Phase 3 trial to ensure that the dosing regimen achieves the plasma drug concentrations observed with the neflamapimod drug product batch that demonstrated significant clinical and biomarker activity in the extension phase of the Phase 2b RewinD-LB trial (DP Batch B).