CervoMed To Report 32-Week Extension Phase Results Of RewinD-LB Study Today

(RTTNews) - CervoMed Inc. (CRVO) is scheduled to present new results from the extension phase of its Phase 2b RewinD-LB study today.

RewinD-LB was a phase IIb placebo-controlled trial, which assessed the investigational drug Neflamapimod for the treatment of dementia with Lewy bodies.

Dementia with Lewy bodies (DLB) is a progressive disease where a protein known as alpha-synuclein builds up to form structures called Lewy bodies in the parts of the brain that control cognition, behavior, and movements. Currently, there are no approved drugs for this condition.

The topline data released last December revealed that the study did not meet statistical significance for its primary endpoint - the change in the Clinical Dementia Rating Sum of Boxes (CDR-SB) - nor any of its key secondary endpoints, including the change from baseline in the Timed Up and Go (TUG) test, the Neuropsychological Test Battery (NTB), or the Clinician's Global Impression of Change (CGIC).

The failure of this study was attributed to the investigational drug capsules used in this phase of the trial, which delivered lower-than-expected plasma drug concentrations, effectively underdosing the participants.

Of the 152 patients who completed the RewinD-LB study, 149 proceeded to the extension phase, where all participants received Neflamapimod, with some having received the old capsules while others received the new capsules.

The results from the first 16 weeks of the extension phase of the Phase 2b RewinD-LB study were reported in March of this year. The study results demonstrated improvement in the primary outcome measure, change from baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB), and the Clinical Global Impression of Change (CGIC). Moreover, a lower incidence of falls was seen in participants receiving the Neflamapimod from the new batch of capsules during the extension phase compared to those who received old capsules.

Today, the company will be presenting the primary endpoint results from the 32-week Extension phase of the RewinD-LB study.

When we alerted readers to CRVO on March 18, 2025, it was trading at $9.93. The stock touched a high of $16.94 on Mar.21, 2025, after which it quickly surrendered these gains, failing to sustain levels above $10. By late June and July, CRVO has been closing in the $5.50 to $8.50 range.

CRVO closed Friday's trading at $8.98, up 11.55%.