CervoMed's Dementia Study: 16-Week Data 'Compelling Enough To Move From Sidelines' Analyst Says

CervoMed Inc. (NASDAQ: CRVO) has just announced positive results from the first 16 weeks of the extension phase of its Phase 2b RewinD-LB study, and the biotech world is buzzing. The study, which focuses on neflamapimod as a treatment for dementia with Lewy bodies (DLB), has shown significant improvements in key clinical endpoints, leading some analysts to suggest that the data is compelling enough to move from the sidelines.

The initial 16-week double-blind phase of the study did not meet statistical significance for its primary endpoint, a change in the Clinical Dementia Rating Sum of Boxes (CDR-SB), nor did it achieve any of its key secondary endpoints. However, the extension phase, which utilized a new batch of neflamapimod capsules, demonstrated a significant improvement in the CDR-SB (p<0.001 vs. old capsules; p=0.003 vs. placebo) and the Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (CGIC) (p=0.035 against either old capsules or placebo). Additionally, a lower incidence of falls was observed in participants receiving the new drug batch during the extension phase.



The key factor that contributed to the lower-than-expected plasma drug concentrations in the initial phase of the study was the age of the drug batch utilized during the double-blind phase. CervoMed addressed this issue by introducing a new batch of capsules that achieved targeted mean plasma concentrations. The new capsules were manufactured more recently and were shown to achieve the targeted plasma concentrations in a food-effect study in healthy volunteers conducted in 4Q 2024. Additionally, within-subject comparison of participants who received older capsules during the double-blind phase of the RewinD-LB trial and new capsules in the open-label extension phase indicated that participants receiving the newer batch capsules, on average, achieved targeted plasma concentrations.

The next steps for CervoMed in advancing neflamapimod through the regulatory approval process involve completing the full 32-weeks of the extension phase of the RewinD-LB study, engaging with regulatory authorities to discuss finalizing Phase 3 plans, and designing a robust Phase 3 trial that builds on the positive results from the extension phase. However, CervoMed may face challenges in moving from Phase 2b to Phase 3 trials, including regulatory scrutiny, ensuring consistent drug delivery, participant recruitment and retention, and addressing safety concerns.

Despite these challenges, the positive results from the extension phase of the RewinD-LB study suggest that neflamapimod has the potential to be an effective treatment for DLB when administered at therapeutically effective levels. As John Alam, MD, Co-Principal Investigator of the RewinD-LB study and CEO of CervoMed, stated, "The results announced today demonstrate the new batch of capsules led to both higher plasma drug concentration levels and improvements on the metrics used as the primary endpoint and a key secondary endpoint in the initial phase of the study." This indicates that the new formulation of neflamapimod may have the potential to fundamentally change the disease course of DLB and our approach to treating the disease, as suggested by James E. Galvin, MD, MPH, Professor of Neurology at the Miller School of Medicine in Miami.

In conclusion, the 16-week data from CervoMed's RewinD-LB study is compelling enough to move from the sidelines, and the biotech world is taking notice. With the potential to fundamentally change the disease course of DLB, neflamapimod could be a game-changer for patients and families impacted by this devastating disease. However, CervoMed will need to navigate the challenges of moving from Phase 2b to Phase 3 trials and engaging with regulatory authorities to bring this potential treatment to market.