Bioavailability data from a Phase 1 study of a stable crystal form of neflamapimod indicate a pharmacokinetic profile largely overlapping the active Phase 2b product; CervoMed selected a 50 mg three-times-daily regimen of the stable form for its planned Phase 3 trial in dementia with Lewy bodies to achieve therapeutic plasma concentrations.

CervoMed Inc. (CervoMed or the Company) (NASDAQ: CRVO), a clinical-stage biotechnology company developing treatments for age-related brain disorders, today announced that it has successfully completed a Phase 1 healthy volunteer study designed to evaluate the pharmacokinetics (PK) of drug product (DP) containing only a new, stable crystal form of neflamapimod and related updates regarding its planned Phase 3 trial in dementia with Lewy bodies (DLB).

Following its evaluation of the study's results, the Company has selected 50mg of the stable crystal form of neflamapimod three times per day (TID) as the dose and dosing regimen for its planned Phase 3 study in patients with DLB. While the PK 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 Company's planned 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).

"The selection of the dosage strength for our planned Phase 3 trial reflects more than a year of focused work by our Chemistry, Manufacturing and Controls team 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," said John Alam, MD, Chief Executive Officer of CervoMed. "By aligning plasma drug concentrations with those achieved from the clinically active DP Batch B capsules and incorporating a stable crystal form of neflamapimod that mitigates prior manufacturing challenges, we believe we are well positioned to replicate the positive clinical outcomes observed in the RewinD-LB trial in our planned Phase 3 trial."

"The process historically used to manufacture neflamapimod produced drug substance containing multiple solid-state forms, also called polymorphs," said Marco Verwijs, PhD, Executive Vice President of Technical Operations at CervoMed. "With prolonged storage, the less-stable, higher-solubility polymorphs converted into a more stable but lower-solubility form, resulting in decreased bioavailability when administered to patients."

Dr. Verwijs continued, "To address this, we have developed and implemented a controlled manufacturing process that only produces the stable crystal form of neflamapimod. While the pharmacokinetic profile of this formulation is largely comparable to the clinically active DP Batch B used in the extension phase of the RewinD-LB trial, we plan to increase the dose to account for its solubility profile and to target the plasma drug concentrations seen with DP Batch B. As a result, we intend to move forward with a 50mg TID dosing regimen of neflamapimod in our planned Phase 3 trial."

About Neflamapimod

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. By targeting the critical disease processes underlying degenerative disorders of the brain, neflamapimod has the potential to reverse synaptic dysfunction, improve neuron health, and slow or prevent disease progression. Neflamapimod is currently in clinical development for the treatment of DLB, recovery after ischemic stroke, and primary progressive aphasia.

In non-clinical studies, neflamapimod restored synaptic function within the basal forebrain cholinergic system, the brain region most affected in DLB. Across Phase 1 and 2 clinical trials involving more than 800 participants, the drug has been generally well tolerated and demonstrated consistent signals of efficacy. In the 91-patient Phase 2a AscenD-LB trial, neflamapimod significantly improved dementia severity and functional mobility in patients with DLB. Results from the 159-patient Phase 2b RewinD-LB trial, a 16-week randomized, double-blind, placebo-controlled trial followed by a 32-week open-label extension, further supported neflamapimod's potential to deliver meaningful clinical benefit, improving both cognitive and functional outcomes and showing a positive effect on a key blood biomarker of neurodegeneration during the extension phase. Across both studies, the greatest benefits were observed in patients without Alzheimer's disease (AD) co-pathology. Collectively, these findings underscore the therapeutic promise and scientific validity of neflamapimod as a potential treatment for DLB and other degenerative brain disorders.

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