CervoMed Inc. Completes Phase 1 PK Study of Stable Crystal Form Of Neflamapimod And Sets 50 mg TID Dose For Upcoming Phase 3 DLB Trial

CervoMed Inc., a clinical-stage biotechnology company developing therapies for age-related brain disorders, announced that it has completed a Phase 1 healthy volunteer study evaluating the pharmacokinetics of a drug product made exclusively with a new, stable crystal form of neflamapimod. The company also provided updates on its planned Phase 3 trial for dementia with Lewy bodies (DLB).

Based on the data from this Phase 1 study, CervoMed has chosen a dosing regimen of 50 mg of the stable crystal form of neflamapimod, taken three times daily, for its upcoming Phase 3 trial in DLB. Although the pharmacokinetic results for 40 mg of DP Batch B and 40 mg of the stable crystal form of neflamapimod were nearly identical, the company plans to increase the dose to 50 mg. This adjustment is intended to match the plasma drug levels achieved with DP Batch B—the batch that showed strong clinical and biomarker results in the extension phase of the Phase 2b RewinD-LB study.

According to John Alam, the company’s Chief Executive Officer, selecting the appropriate dose for Phase 3 reflects more than a year of work by CervoMed’s Chemistry, Manufacturing and Controls team. He explained that this effort focused on understanding the cross-batch differences observed in the RewinD-LB Phase 2b trial, where one batch (DP Batch A) underperformed. By designing a dosing regimen that replicates the plasma concentrations from the effective DP Batch B and by adopting a more stable crystal form of neflamapimod to prevent manufacturing inconsistencies, the company believes it is positioned to reproduce the positive outcomes seen in earlier clinical results.

Marco Verwijs, Executive Vice President of Technical Operations at CervoMed, noted that the earlier manufacturing process for neflamapimod often produced drug substance containing multiple solid-state forms, or polymorphs. Over time, these less-stable but higher-solubility forms would convert into a more stable form with lower solubility, which reduced the drug’s bioavailability when given to patients.

He added that the company has since developed a controlled manufacturing method that produces only the stable crystal form of neflamapimod. While this new formulation shows a pharmacokinetic profile similar to the clinically active DP Batch B used in the RewinD-LB extension study, the Phase 3 study will use a slightly higher dose to account for solubility considerations and to target the plasma drug levels associated with the earlier positive results. As a result, CervoMed plans to move forward with a 50 mg three-times-daily dosing regimen for neflamapimod in its Phase 3 DLB trial.