CervoMed Advances Neflamapimod With New Tablet Formulation And FDA Dose Flexibility
(RTTNews) - CervoMed Inc. (CRVO) announced pharmacokinetic, regulatory, and manufacturing advances for neflamapimod, including a new 50 mg oral tablet formulation and the FDA's removal of a previous plasma drug exposure limit.
The new 50 mg tablet was evaluated in a Phase 1 food-effect and drug-exposure study and met its primary objectives.
Following single-dose administration, the 50 mg tablet and the previous 40 mg capsule produced similar overall plasma drug exposure. However, the new tablet showed approximately 20% lower peak plasma concentration (Cmax) and approximately 20% higher plasma concentration 12 hours after dosing (Ctrough), supporting twice-daily administration.
The new tablet uses the most stable crystalline form of neflamapimod and was developed to address manufacturing variability observed with the 40 mg capsule used in the Phase 2b RewinD-LB study.
CervoMed has also implemented a controlled manufacturing process designed to support reproducible, large-scale tablet production and reduce chemistry, manufacturing and controls (CMC) risk for future clinical development and potential commercial supply.
The FDA removed the previous plasma drug exposure limit for neflamapimod following review of a 39-week dog toxicology study completed in the first half of 2026.
The study established a no-observed-adverse-effect level (NOAEL) based on plasma drug levels that was three-fold higher than levels established in earlier dog toxicology studies and more than 30-fold higher than the pharmacologically and clinically active exposure range observed in previous clinical trials.
Based on the new pharmacokinetic profile and PK-PD relationships observed across clinical studies, CervoMed plans to advance a 100 mg twice-daily (BID) regimen in future clinical trials.
PK modeling indicates that the planned regimen is expected to increase trough plasma drug concentrations by approximately 33% compared with the 40 mg three-times-daily (TID) regimen used in the Phase 2a study and the extension phase of the Phase 2b trial in dementia with Lewy bodies (DLB).
The planned 100 mg BID tablet regimen is expected to provide similar overall plasma exposure to 80 mg BID, while producing higher Ctrough and lower Cmax.
CervoMed said the dosing strategy is intended to increase pharmacologically relevant trough concentrations while limiting peak exposure, as previous PK-PD analyses linked clinical activity more closely with Ctrough and safety and tolerability with Cmax.
The planned higher-dose regimen is also supported by clinical data from patients treated with neflamapimod at 80 mg BID, presented at the Alzheimer's Association International Conference in July 2026.
CervoMed's lead candidate, neflamapimod, is an oral small-molecule inhibitor targeting a key enzyme involved in neuroinflammation and neurodegeneration and is being developed for age-related brain disorders.
The company has completed the Phase 2b RewinD-LB trial in DLB and is focused on identifying a strategic partner to advance neflamapimod into a Phase 3 trial.
CervoMed has also completed enrollment in a Phase 2a trial evaluating neflamapimod in nonfluent/agrammatic primary progressive aphasia (nfvPPA), with interim biomarker data expected in early Q4 2026.
The company expects the first patient to be dosed in the EXPERTS-ALS Phase 2a clinical trial in Q4 2026.
CRVO has traded between $2.13 and $10.00 over the last year.
The stock closed Monday's trade at $2.54, up 0.79%. In the pre-market trading, the stock is trading at $2.54, without any movement on the Nasdaq.
