CervoMed (CRVO) Earnings Call Presentation

Clinical Trial Overview - The RewinD-LB phase 2b clinical trial investigated neflamapimod in dementia with Lewy bodies (DLB)[3] - The trial randomized 159 participants 1:1 to neflamapimod 40mg or placebo TID for 16 weeks, followed by a 32-week open-label extension[20] - The primary outcome measure was the Clinical Dementia Rating Sum of Boxes (CDR-SB)[20] Efficacy Results - The primary statistical analysis showed no discernible differences between the neflamapimod and placebo groups in change from baseline on CDR-SB (NFMD-Placebo Difference: 0.01)[29] - Secondary endpoint CGIC results showed Number of Participants in Each Category at Week 16[34] Safety and Tolerability - The study was generally well-tolerated, with no new safety signals[37] - There were 8 serious adverse events (SAEs) in the placebo group and 5 in the neflamapimod group[37] - The most common treatment emergent adverse event was falls, occurring in 18.8% of the placebo group and 15.2% of the neflamapimod group[38] Plasma Drug Concentrations - Mean trough plasma drug concentration (Ctrough) in RewinD-LB was 3.9 ng/mL[42, 43, 44] - This Ctrough level was similar to that seen with 40mg BID in earlier studies, lower than targeted[42, 43, 44] - Analysis suggests lower bioavailability related to the age of the capsules used during the double-blind phase[49] Open-Label Extension (OLE) and Future Directions - The open-label extension (OLE) of the study introduced a newer batch of capsules[44] - Week 16 OLE analysis is upcoming in March 2025[46] - A clinical study evaluating the safety and pharmacokinetics of 80mg BID in DLB is ongoing[49]