CervoMed presents new neflamapimod data at AAIC, backs 50 mg dose for DLB Phase 3

CervoMed Inc. (NASDAQ: CRVO) presented new analyses of neflamapimod at the Alzheimer's Association International Conference 2026 in London this week, drawn from its 159-patient Phase 2b RewinD-LB trial, a 16-week randomized, double-blind, placebo-controlled study followed by a 32-week neflamapimod-only extension, plus additional preclinical and clinical work.¹

The company said the trial's failure to replicate earlier Phase 2a results on the CDR-SB scale can be attributed to a combination of a higher-than-targeted proportion of patients with Alzheimer's disease co-pathology and use of a drug batch that did not achieve expected plasma drug concentrations.¹ A within-participant analysis found that a batch achieving higher plasma concentrations showed a significant improvement in CDR-SB change compared to placebo (0.17 increase versus 0.95 with placebo, p=0.005), while the earlier batch showed no such within-subject improvement.¹

Imaging data showed neflamapimod-treated participants had increased right basal forebrain volume relative to placebo over the 16-week placebo-controlled period, measured by structural and functional MRI.¹ That volume remained stable over 48 weeks in continuously treated participants and stabilized after treatment initiation in the extension for prior placebo recipients.¹

Based on pharmacokinetic-pharmacodynamic modeling, the company selected a 50 mg TID dose for future trials, expected to achieve at or above a plasma Ctrough threshold of about 4 ng/mL in approximately 90% of patients.¹

Separately, a Phase 2 study of an 80 mg twice-daily dose met its primary objectives for safety, tolerability, and pharmacokinetics, was well tolerated with no new safety signals over 24 weeks in 26 participants with DLB, though the dose increase in Ctrough was not proportional to the 40 mg TID dose used previously.¹

CervoMed said it has gained alignment with the FDA, European Medicines Agency, MHRA and Japan's Pharmaceuticals and Medicines Devices Agency¹ on the patient population and dose for the planned Phase 3 trial.