CervoMed Inc. (NASDAQ: CRVO) announced pharmacokinetic results for a new 50 mg oral tablet formulation of neflamapimod and said the U.S. Food and Drug Administration has removed a prior plasma drug exposure limit that had constrained dosing in clinical trials.

The new tablet formulation showed approximately 20% lower peak plasma concentration and approximately 20% higher plasma trough concentration 12 hours after dosing compared with the prior 40 mg capsule used in the Phase 2b RewinD-LB study. The company said the new formulation uses the most stable crystalline form of neflamapimod, addressing manufacturing variability observed with the earlier capsule.

The FDA's decision to remove the exposure limit followed a 39-week dog toxicology study completed in the first half of 2026. That study established a no-observed-adverse-effect level three-fold higher than in prior dog studies and more than 30-fold higher than the exposure range observed in previous clinical trials.

Based on these results, CervoMed plans to advance a 100 mg twice-daily regimen in future trials. Pharmacokinetic modeling indicates this regimen is expected to increase trough plasma drug concentrations by approximately 33% relative to the 40 mg three-times-daily regimen used in prior Phase 2 studies, while reducing dosing frequency.

"Combined with the FDA's removal of the prior exposure limit, the new pharmacokinetic profile enables us to advance a 100 mg twice-daily regimen that we expect will achieve substantially higher trough drug concentrations than those associated with clinical activity in previous trials," said John J. Alam, M.D., Chief Executive Officer of CervoMed.

The company also noted that clinical safety data for neflamapimod at 80 mg twice daily, presented at the Alzheimer's Association International Conference in July 2026, supports the tolerability of the planned higher dose. The 100 mg twice-daily tablet regimen is expected to provide similar overall plasma exposure to the 80 mg twice-daily regimen, with a higher trough and lower peak concentration.

CervoMed is currently seeking a strategic partner to advance neflamapimod into a Phase 3 trial for dementia with Lewy bodies.