CervoMed presents neflamapimod DLB trial data at AAIC 2026
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CervoMed Inc. (NASDAQ: CRVO) presented new analyses of its neflamapimod drug candidate in dementia with Lewy bodies (DLB) at the Alzheimer's Association International Conference in London on July 14, 2026.
The data came from new analyses of the 159-patient Phase 2b RewinD-LB trial, a 16-week randomized, double-blind, placebo-controlled study followed by a 32-week neflamapimod-only extension. The company said the trial's primary endpoint was not met, attributing this to a higher-than-targeted proportion of patients with Alzheimer's disease co-pathology and a drug product batch that did not achieve expected plasma concentrations.
Exploratory analyses showed that patients with low plasma pTau181 levels — below 21 pg/mL, a threshold identified in scientific literature to exclude Alzheimer's pathology — who also achieved above-median trough plasma drug concentrations showed improvement on the Clinical Dementia Rating – Sum of Boxes scale relative to placebo.
A within-participant comparison using a second drug batch that achieved higher plasma concentrations showed a statistically significant difference in CDR-SB change versus placebo (0.17 increase vs. 0.95 with placebo, p=0.005), where a higher score indicates disease worsening.
On imaging measures, neflamapimod-treated participants showed increased right basal forebrain volume relative to placebo over 16 weeks, with volume remaining stable over 48 weeks. Increases in functional connectivity between the right basal forebrain and the right default mode network were also observed during the extension phase.
A separate Phase 2 study evaluating an 80 mg twice-daily dose in 26 DLB patients over 24 weeks met its primary objectives for safety, tolerability, and pharmacokinetics, with no new safety signals identified.
Based on these findings, CervoMed selected a 50 mg three-times-daily dose for its planned Phase 3 trial, which the company said is expected to achieve target plasma concentrations in approximately 90% of patients. The company stated it has received alignment on the Phase 3 plan from the U.S. Food and Drug Administration, European Medicines Agency, and other regulators, and is currently seeking a strategic partner to advance the trial.
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