CervoMed Inc. (NASDAQ: CRVO) filed a Current Report on Form 8-K on September 28, 2026, disclosing updates regarding its lead drug candidate, neflamapimod. The company announced advancements in pharmacokinetics, regulatory status, and manufacturing for the oral tablet formulation.
The company has developed a new 50 mg oral tablet containing the most stable crystalline form of neflamapimod. This formulation is intended to address manufacturing variability observed with the 40 mg capsule used in the Phase 2b RewinD-LB study. A Phase 1 food-effect and drug-exposure study evaluated the new tablet, finding that while overall plasma exposure was similar to the prior capsule, the tablet demonstrated a pharmacokinetic profile better suited for twice-daily administration. Specifically, the 50 mg tablet showed approximately 20% lower peak plasma concentration (C max) and approximately 20% higher plasma concentration 12 hours post-dose (C trough) compared to the capsule.
Regulatory updates include the U.S. Food and Drug Administration’s removal of a previous plasma drug exposure limit. This decision was based on a 39-week dog toxicology study completed in the first half of 2026, which established a no-observed-adverse-effect level (NOAEL) that was three-fold higher than prior studies and more than 30-fold higher than the active exposure range seen in previous clinical trials.
Based on these developments, CervoMed plans to advance a 100 mg twice-daily regimen in future clinical trials. PK modeling indicates this higher daily dose is expected to increase trough plasma drug concentrations by approximately 33% relative to the 40 mg three-times-daily regimen used in prior trials. The company noted that clinical activity is associated with C trough, while safety is more closely related to C max, suggesting the new regimen aims to increase pharmacologically relevant trough levels without a commensurate increase in peak exposure.
The company also highlighted its ongoing clinical programs, including the recently completed Phase 2a trial in nfvPPA and the upcoming EXPERTS-ALS Phase 2a trial, where the first patient is expected to be dosed in the fourth quarter of 2026.
