CervoMed Inc. (NASDAQ: CRVO) saw its stock price plummet on Tuesday following the release of disappointing topline results from its Phase 2b RewinD-LB clinical trial. The trial evaluated the efficacy of neflamapimod, an investigational drug for dementia with Lewy bodies (DLB).
The RewinD-LB trial failed to achieve statistical significance for its primary endpoint, which measured changes in dementia severity using the Clinical Dementia Rating Sum of Boxes. Furthermore, the drug did not meet any of its key secondary endpoints, including measures of mobility, balance, cognitive function, and overall clinical impression.
Preliminary analysis suggests that the trial’s failure may be attributed to insufficient plasma drug concentrations during the double-blind phase. This unexpected finding raises concerns about the drug’s effectiveness in treating DLB.
“We are deeply disappointed with these results, especially considering neflamapimod’s previous performance in early-stage DLB patients,” stated John Alam, CEO of CervoMed. “We are actively investigating the reasons behind the lower-than-anticipated plasma drug levels.”
Despite the setback, CervoMed emphasized that neflamapimod exhibited a favorable safety and tolerability profile consistent with earlier clinical studies. No new safety concerns were identified during the RewinD-LB trial.
The company anticipates receiving the complete dataset from the double-blind phase of the trial in January 2025. Data from the first 16 weeks of the open-label extension phase is expected in the late second quarter of 2025. This extended data may provide further insights into the drug’s performance and potential future development.
While the RewinD-LB results represent a significant setback for CervoMed, the company recently received Orphan Drug Designation from the FDA for neflamapimod in the treatment of frontotemporal dementia (FTD). This designation highlights the unmet medical need in FTD and offers certain incentives for drug development, potentially providing a different avenue for neflamapimod’s future.
As of Tuesday’s market close, CRVO stock was trading at $2.24, reflecting a dramatic 78.2% decline. The market reacted strongly to the negative trial results, underscoring the high expectations and significant risks associated with drug development in the challenging field of dementia.
