CervoMed Inc. (NASDAQ:CRVO) on Wednesday shared additional data from its Phase 2b RewinD-LB trial of neflamapimod for dementia with Lewy bodies (DLB).
The results are based on the final analyses of the RewinD-LB trial, conducted after the August 2025 database lock for the full 48-week trial (16 weeks placebo-controlled (Initial Phase), followed by a 32-week neflamapimod-only extension (Extension Phase)).
In the subset of participants whose plasma ptau181 levels were below 21 pg/mL at screening, results include:
On the primary endpoint of change in Clinical Dementia Rating Sum of Boxes (CDR-SB) over 16 weeks, there was a trend toward NFMD/A (Drug product batch that did not achieve targeted plasma drug concentrations, “old capsules”) relative to placebo during the Initial Phase of the trial.
NFMD/B (drug product batch that achieved plasma drug concentrations, “new capsules”) demonstrated significant improvement versus NFMD/A on CDR-SB (−0.58, p=0.024), as well as on the ADCS-CGIC, Dementia-Cognitive Fluctuations Scale, and International Shopping List Test-Recognition, over the first 16 weeks of the Extension Phase.
Participants who transitioned from placebo to NFMD/B showed significant improvement in change in CDR-SB and on ADCS-CGIC while on NFMD/B relative to when on placebo over the respective 16-week periods.
NFMD/B reduced the risk of clinically meaningful progression by 67% versus NFMD/A over 32 weeks and 75% versus placebo over 16 weeks.
Also Read: CervoMed’s Dementia Data Show Slowed Disease Progression
The new plasma glial fibrillary acidic protein (GFAP) analyses in the subset of participants show:
Among participants who received a placebo and then transitioned to NMFD/B in the Extension Phase, the change in plasma GFAP (a biomarker of neurodegeneration) over 32 weeks of NMFD/B treatment was significantly lower than the change observed over 16 weeks of placebo treatment in the same individuals, representing an estimated 50% reduction in disease-specific elevation in plasma GFAP levels.
In participants with a low likelihood of AD co-pathology, plasma GFAP change significantly correlated with CDR-SB change.
Specifically, reductions in plasma GFAP were associated with improvements in CDR-SB scores (lower dementia severity), whereas increases in plasma GFAP corresponded to worsening scores.
CRVO Price Action: CervoMed shares are up 7.97% at $9.21 at the time of publication on Wednesday. It hit an intraday high of $9.30 and dipped to a low of $8.64. The stock is still 45.6% below its 52-week high, but it’s trading 34.6% above its 200-day moving average.
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