CervoMed announced positive 16-week results from the extension phase of its Phase 2b RewinD-LB study of neflamapimod for dementia with Lewy bodies (DLB). A new batch of neflamapimod capsules, addressing prior bioavailability issues, showed significant improvement in cognitive function and a lower incidence of falls compared to the old capsules and placebo. The positive data reinforces the potential of neflamapimod as a treatment for DLB, a disease currently lacking approved therapies.
This news holds substantial promise for DLB patients, who currently face limited treatment options. The observed improvements in cognitive function, measured by the Clinical Dementia Rating Sum of Boxes (CDR-SB) and the Alzheimer’s Disease Cooperative Study – Clinical Global Impression of Change (CGIC), are clinically meaningful. Furthermore, the reduction in falls, a significant concern for DLB patients, suggests a potential improvement in their overall well-being and quality of life. This progress underscores the urgent need for effective DLB treatments and positions neflamapimod as a potential game-changer.
The study’s extension phase involved 149 participants, with 94 receiving the new neflamapimod capsules. These participants demonstrated statistically significant improvement (p<0.001) on the CDR-SB compared to those receiving the old capsules. Analysis against the placebo group from the initial phase also revealed significant improvement (p=0.003). The CGIC score, indicating disease worsening, improved with the new capsules (p=0.035). Importantly, the new capsules were associated with a lower incidence of falls compared to both old capsules and placebo. Pharmacokinetic analysis confirmed the new capsules achieved higher plasma drug concentrations, validating the hypothesis that previous results were hampered by bioavailability issues. The positive results from the extension phase pave the way for CervoMed to finalize its Phase 3 plans. With the completion of the full 32-week extension phase later this year and subsequent discussions with regulatory authorities, neflamapimod could advance towards becoming a much-needed treatment option for DLB patients. This progress represents a significant step forward in addressing this debilitating disease.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
