Neflamapimod RewinD-LB Extension Data, CHMP Reaffirms Lecanemab Stance, Donanemab Associated With Increased ARIA Risk

WATCH TIME: 3 minutes

Welcome to this special edition of Neurology News Network. I'm Marco Meglio.

According to a recent company update from CervoMed, positive results from the first 16 weeks of the extension phase of the phase 2b RewinD-LB study (NCT05869669) of neflamapimod showed that treatment with newly formulated neflamapimod capsules demonstrated significant clinical benefits in patients with dementia with Lewy bodies (DLB) compared with an old batch and placebo.1 Presented at the 8th International Lewy Body Dementia Conference, these results suggest that neflamapimod has the potential to positively impact the course of DLB, particularly with its new formulation. To analyze the change from baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB), the primary end point of the initial phase, the study employed a linear mixed-effects model for repeated measures. From the end of the initial phase through week 16, the change in CDR-SB was shown to be significantly lower in the new capsule group compared with the old capsule group (difference = -0.73; 95% CI, -1.14 to -0.32; P <.001)

According to a recent announcement, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) reasserted stance on its recent positive opinion of lecanemab (Leqembi; Eisai), an antiamyloid therapy for patients with early-stage Alzheimer disease (AD). The European Commission (EC) is expected to continue its review of the therapy, and, if approved, the therapy would become available to all 27 European Union member states. In January, as part of its decision-making process, the EC asked the CHMP to consider information on the safety of lecanemab that became available after the adoption of the CHMP opinion in November 2024 and whether this may require an update of the opinion, and to consider whether the wording of the risk minimization measures in the opinion is clear enough to ensure correct implementation. After reviewing the additional information, the CHMP concluded that its positive opinion for lecanemab does not need to be updated.

A recently published post-hoc exploratory analysis of the placebo-controlled TRAILBLAZER-ALZ studies revealed that treatment with donanemab (Kisulna; Eli Lilly) is associated with elevated risk for amyloid-related imaging abnormalities (ARIA), as around one-fourth of treated patients experienced ARIA-edema/effusions (ARIA-E). Overall, these reinforce the idea that safety monitoring is necessary with donanemab as with other amyloid-targeting treatments in patients with Alzheimer disease (AD). Led by Jennifer A. Zimmer, MD, a pediatric neurologist based in Indianapolis, Indiana, ARIA occurred in 37.0% of donanemab-treated patients in placebo-controlled trials, 32.0% in the open-label addendum, and in 14.2% of those on placebo. ARIA-E occurred in 19.8%-24.4% of donanemab-treated participants and 1.9% of placebo participants, while ARIA-H occurred in 27.2%-31.3% and 13.0%, respectively, with similar rates of isolated ARIA-H (11.7%-12.5%) and macrohemorrhage (0.2%-0.4%) across all groups.

For more direct access to expert insight, head to NeurologyLive.com. This has been Neurology News Network. Thanks for watching.