CervoMed announce new data from Phase 2b trial of RewinD-LB

CervoMed (CRVO) announced additional data from its Phase 2b RewinD-LB trial, further demonstrating neflamapimod’s potential as a treatment for dementia with Lewy bodies. In the subset of participants whose plasma ptau181 levels were below 21 pg/mL at screening, results include: Initial Phase: On the primary endpoint of change in CDR-SB over 16 weeks, there was a trend toward NFMD/A relative to placebo during the Initial Phase of the trial. Extension Phase: NFMD/B demonstrated significant improvement versus NFMD/A on CDR-SB, as well on the ADCS-CGIC, Dementia-Cognitive Fluctuations Scale, and International Shopping List Test-Recognition, over the first 16 weeks of the Extension Phase. Within-Subject Comparison to Placebo: Participants who transitioned from placebo in the Initial Phase to NFMD/B in the Extension Phase showed significant improvement on change in CDR-SB and on ADCS-CGIC while they were on NFMD/B relative to when on placebo over the respective 16-week periods. The new plasma GFAP analyses in the subset of participants whose plasma ptau181 levels were below 21 pg/mL at screening are summarized below: Within-Subject Comparison to Placebo: Among participants who received placebo during the Initial Phase and then transitioned to NMFD/B in the Extension Phase, the change in plasma GFAP over 32 weeks of NMFD/B treatment was significantly lower than the change observed over 16 weeks of placebo treatment in the same individuals. Correlation with Clinical Outcomes: During the Extension Phase, 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.