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.
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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