On Tuesday, CervoMed Inc. ( CRVO ) stock is trading lower after the company revealed topline data from the RewinD-LB Phase 2b clinical trial evaluating neflamapimod for dementia with Lewy bodies (DLB).

The trial did not meet statistical significance thresholds for its primary endpoint of change in the Clinical Dementia Rating Sum of Boxes (a measure of dementia severity) or any of its key secondary endpoints – change from baseline in Timed Up and Go (measures a person’s mobility, balance, and risk of falling) test, change from baseline in a Neuropsychological Test Battery (assess cognitive function in various areas of the brain), and the Clinician’s Global Impression of Change (change observed in a patient).

Initial analysis shows that target plasma drug concentrations were not achieved during the double-blind phase of the trial, which may have adversely impacted trial results.

“Obviously, we are disappointed with these results, particularly given our prior clinical experience with neflamapimod in patients with early-stage DLB and we are investigating the reasons for the lower-than-expected plasma drug concentrations,” said John Alam, Chief Executive Officer of CervoMed ( CRVO ).

In the RewinD-LB Phase 2b trial, neflamapimod demonstrated a favorable safety and tolerability profile consistent with prior clinical studies, with no new safety signal identified.

The full data set from the double-blind phase of the RewinD-LB trial is expected to be available to the company in January 2025, and the data from the first 16 weeks of the open-label extension portion of the trial are expected to be available in the late second quarter of 2025.

In November, the FDA granted Orphan Drug Designation to neflamapimod for frontotemporal dementia (FTD).

Price Action: CRVO stock is down 78.2% at $2.24 last check Tuesday.

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