BOSTON, March 4, 2026 — Leads & Copy — CervoMed Inc. (NASDAQ: CRVO), a biotechnology company focused on treatments for age-related brain disorders, has announced the successful completion of a Phase 1 study evaluating the pharmacokinetics of a new, stable crystal form of neflamapimod, along with updates on its planned Phase 3 trial for dementia with Lewy bodies (DLB).
Following the evaluation of the Phase 1 study results, CervoMed has selected a dose of 50mg of the stable crystal form of neflamapimod, to be administered three times daily (TID), for its planned Phase 3 study in DLB patients.
According to CervoMed, while the pharmacokinetic profiles of 40mg of DP Batch B and 40mg of the stable crystal form of neflamapimod are largely overlapping, the dose will be increased to 50mg in the Phase 3 trial to ensure that the dosing regimen achieves the plasma drug concentrations observed with the neflamapimod drug product batch that demonstrated significant clinical and biomarker activity in the extension phase of the Phase 2b RewinD-LB trial (DP Batch B).
CervoMed Chief Executive Officer Dr. John Alam said that the dosage strength selection for the planned Phase 3 trial reflects over a year of focused work to understand and address the cross-batch variability and underperformance observed with the ineffective drug product batch (DP Batch A) in the RewinD-LB Phase 2b trial.
Dr. Marco Verwijs, Executive Vice President of Technical Operations at CervoMed, said the company has developed and implemented a controlled manufacturing process that only produces the stable crystal form of neflamapimod.
Dr. Verwijs added that the company plans to increase the dose to account for the solubility profile of the stable crystal form and to target the plasma drug concentrations seen with DP Batch B.
Additional information regarding these results and comparative pharmacokinetic data are available in the company’s corporate presentation on the “Events and Presentations” page of CervoMed’s website.
Neflamapimod is an investigational, orally administered small-molecule drug that readily crosses the blood–brain barrier and selectively inhibits the alpha isoform of p38 MAP kinase, a key driver of neuroinflammation and synaptic dysfunction. It is currently in clinical development for the treatment of DLB, recovery after ischemic stroke, and primary progressive aphasia.
CervoMed is a clinical-stage company developing treatments for age-related brain disorders. Its lead drug candidate, neflamapimod, is an oral small molecule targeting critical disease processes underlying degenerative disorders of the brain by inhibiting a key enzyme involved in neuroinflammation and neurodegeneration. The Company plans to initiate a global, pivotal Phase 3 trial in patients with DLB, enriched for those without AD co-pathology, in the second half of 2026, subject to available funding.
Source: CervoMed
