BOSTON — September 28, 2026
CervoMed Inc. announced pharmacokinetic, regulatory and manufacturing advances for neflamapimod, including a new 50 mg oral tablet formulation and the U.S. Food and Drug Administration’s removal of a previous plasma drug exposure limit. The developments are intended to support evaluation of a higher-dose, twice-daily regimen in future clinical trials of the investigational therapy for age-related brain disorders. In a Phase 1 food-effect and drug-exposure study, the new tablet produced overall plasma exposure similar to the prior 40 mg capsule while showing approximately 20% lower peak plasma concentration (Cmax) and approximately 20% higher 12-hour plasma concentration (Ctrough). CervoMed plans to advance a 100 mg twice-daily regimen, with pharmacokinetic modeling indicating higher trough concentrations than the 40 mg three-times-daily regimen used in earlier dementia with Lewy bodies studies.
New Tablet Addresses Formulation and Manufacturing Variability
The new 50 mg tablet contains the most stable crystalline form of neflamapimod and was developed to address manufacturing variability identified with the 40 mg capsule used in the Phase 2b RewinD-LB study. The company has also implemented a controlled manufacturing process intended to support reproducible, large-scale tablet production and reduce chemistry, manufacturing and controls risk. The Phase 1 food-effect and drug-exposure study met its primary objectives and showed comparable overall plasma exposure between the new tablet and the previous capsule formulation following single-dose administration. However, the tablet produced a pharmacokinetic profile that CervoMed said is better suited to twice-daily administration, with lower peak exposure and higher concentrations 12 hours after dosing. The formulation is intended for future clinical development and, if eventually approved, potential commercial supply.
FDA Removes Previous Neflamapimod Exposure Limit
The FDA has removed a previous plasma drug exposure limit that had constrained neflamapimod dosing in clinical development, following review of new toxicology data. CervoMed reported that a 39-week dog toxicology study completed in the first half of 2026 established a no-observed-adverse-effect level based on plasma drug concentrations that was three times higher than levels established in earlier dog studies. According to the company, the exposure level was also more than 30 times higher than the pharmacologically and clinically active exposure range observed in previous neflamapimod clinical trials in central nervous system disorders. The regulatory change provides greater flexibility for dose selection in future human studies, although the investigational drug will require continued clinical evaluation to establish the safety and efficacy of higher-dose regimens.
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CervoMed Plans 100 mg Twice-Daily Clinical Development
CervoMed plans to evaluate a 100 mg twice-daily neflamapimod regimen based on the new tablet’s pharmacokinetic characteristics and previously developed PK-PD relationships. Modeling indicates that the planned regimen could increase trough plasma concentrations by approximately 33% compared with the 40 mg three-times-daily regimen used in earlier DLB studies. The company said prior clinical experience with 80 mg twice daily, presented at AAIC 2026, provides additional safety and tolerability information for the planned dose. Neflamapimod is an investigational oral small molecule designed to inhibit an enzyme involved in neuroinflammation and neurodegeneration. CervoMed is seeking a strategic partner for a potential Phase 3 DLB program, while a Phase 2a study in nonfluent/agrammatic primary progressive aphasia is ongoing and an EXPERTS-ALS Phase 2a trial is expected to begin dosing in the fourth quarter of 2026.
Source :CervoMed press release
