CervoMed Inc. announced significant pharmacokinetic, regulatory, and manufacturing updates for its lead drug candidate, neflamapimod. The company has developed a new 50 mg oral tablet formulation with an improved pharmacokinetic profile and has secured the FDA's removal of a prior drug exposure limit. These developments allow the company to advance a higher, more convenient 100 mg twice-daily (BID) dosing regimen in future clinical trials, which is expected to increase efficacy and reduce clinical and manufacturing risks.
Key Details
- New Formulation: A new 50 mg oral tablet has been developed to replace the previous 40 mg capsule. It demonstrates a pharmacokinetic profile better suited for twice-daily dosing, with ~20% lower peak concentration and ~20% higher concentration at 12 hours post-dose.
- Regulatory Update: Following a 39-week toxicology study, the U.S. FDA has removed the previous plasma drug exposure limit for neflamapimod, providing greater dosing flexibility in future trials.
- Future Dosing Regimen: CervoMed plans to advance a 100 mg twice-daily regimen. This is expected to increase trough plasma drug concentrations by approximately 33% compared to the 40 mg three-times-a-day regimen used in prior successful trials, which is associated with clinical activity.