CRVO Phase 2b Results Highlight Neflamapimod’s Significant Clinical Benefit for Dementia with Lewy Bodies

Subgroup Data Reveal Stronger Benefit in Patients Without Alzheimer’s Co-Pathology

On October 8, 2025, CervoMed announced new analyses from its Phase 2b RewinD-LB trial that sharpen the profile of neflamapimod as a promising treatment for dementia with Lewy bodies (DLB). By focusing on participants whose biomarker profiles indicate a low likelihood of Alzheimer’s disease (AD) co-pathology—about half of all DLB cases—the company reported clear and meaningful clinical gains for these patients.

DLB, one of the most common forms of progressive dementia, is notoriously challenging to treat, especially when complicated by concurrent AD pathology. With advances in blood-based biomarkers like plasma ptau181, researchers now better differentiate these patient subgroups. CervoMed adapted its statistical plan to reflect the latest insights—namely, that a ptau181 cutoff below 21 pg/mL identifies a “purer” DLB group, the very patients most likely to benefit from new disease-modifying therapies like neflamapimod.

Neflamapimod Demonstrates Meaningful Clinical Improvement Over Placebo and Older Formulations

Participants meeting this more selective biomarker cutoff (<21 pg/mL ptau181) experienced substantial improvements during the trial. When transitioning from placebo to the optimized “new capsules” batch of neflamapimod (NFMD/B), these individuals saw their Clinical Dementia Rating Sum of Boxes (CDR-SB) scores improve by -1.12 points compared to their performance on placebo, a result both statistically significant (p=0.005) and clinically meaningful.

Other secondary measures, including the ADCS-CGIC and cognitive fluctuation tests, reinforced these benefits. Importantly, participants receiving the NFMD/B batch faced a dramatically reduced risk of progression—a 75% risk reduction in clinically meaningful worsening over 16 weeks compared to placebo. Such findings, even in a smaller exploratory sample, support further development and give hope to patients and families impacted by DLB.

Biomarker Reduction Strongly Correlates with Improved Cognitive Outcomes

One of the study’s most compelling insights links improvements in the clinical dementia scale to parallel reductions in a key blood-based biomarker, plasma glial fibrillary acidic protein (GFAP). Over 32 weeks of neflamapimod therapy, patients saw median GFAP levels fall by 16.70 pg/mL—contrasting sharply with an average rise of 5.80 pg/mL during the placebo period (p=0.016). Notably, changes in GFAP tracked directly with shifts in cognitive performance: decreases in GFAP associated with CDR-SB improvements, while rising levels signaled decline.

This tight relationship not only supports the clinical effect of neflamapimod, but also underscores the utility of GFAP as a “real-world” marker for DLB progression and therapeutic response.

Path to Phase 3: Refined Criteria Aim to Maximize Impact

The take-home for investors and clinicians is clear: with the U.S. Food and Drug Administration expected to provide feedback on the pivotal Phase 3 trial design in the coming months, CervoMed now has a more precise blueprint for enrolling the patients most likely to benefit. By leveraging up-to-date biomarker cutoffs and selecting for those without AD co-pathology, future studies are positioned to capture and potentially replicate the dramatic effect sizes seen in Phase 2b.

As the company looks ahead to Phase 3, investors should watch for additional trial details and regulatory milestones—these will be critical in gauging the timing and trajectory of neflamapimod’s potential approval.

Key Takeaway: Robust Phase 2b Data Suggest Disease-Modifying Promise

CervoMed’s latest Phase 2b analyses signal that neflamapimod, especially in patients without Alzheimer’s co-pathology, could shift the paradigm in DLB care. With biomarker and cognitive benefits now strongly correlated, and large relative reductions in progression risk, the forthcoming Phase 3 will be watched closely by the market and the neurology community alike.

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