CervoMed Reports Positive Phase 2b Extension Results for Neflamapimod in Lewy Body Dementia

CervoMed Inc., a clinical-stage company focusing on age-related neurological disorders, has announced positive outcomes from the 16-week extension phase of its Phase 2b RewinD-LB study, which is evaluating neflamapimod for the treatment of dementia with Lewy bodies (DLB). This study highlights significant improvements in clinical measures and suggests a potential new approach for managing DLB.

The study demonstrated that a new batch of neflamapimod capsules led to increased plasma drug concentrations and showed substantial improvement in the primary outcome of Clinical Dementia Rating Sum of Boxes (CDR-SB) scores when compared to both the old capsules and placebo. Statistically significant improvements were also observed in the Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (CGIC). Participants receiving the new capsules experienced a lower rate of falls during the extension phase, suggesting an additional benefit of the new formulation.

The RewinD-LB study enrolled 159 participants for its initial 16-week, double-blind, placebo-controlled phase, of which 152 participants completed this phase. Afterward, 149 participants entered the 16-week extension phase, during which they all received neflamapimod in an open-label manner. Interestingly, the extension phase revealed the new capsules, provided to 94 of the 149 participants, resulted in both higher plasma drug concentration and significant clinical improvements. The new batch of capsules led to a noticeable drop in CDR-SB scores at Week 16 of the extension, demonstrating a more pronounced effect compared to the old capsules.

Furthermore, on the CGIC scale, the new capsules showed improved scores compared to the old capsules, indicating less worsening of symptoms. This effect was even more pronounced in participants who had lower screening plasma ptau181 levels, which are indicative of Alzheimer’s disease-related co-pathology.

In terms of safety, both the old and new capsules displayed similar tolerability profiles, with no new safety concerns arising during the study. Significantly, the incidence of falls was lower among participants who received the new capsules compared to those who were given the old capsules during the extension, as well as compared to those who received a placebo in the initial phase.

The pharmacokinetic analysis indicated that the new capsules resulted in higher mean plasma drug concentrations. This was attributed to improved dissolution kinetics rather than chemical degradation, which was a concern with the older capsules likely due to their age.

These findings suggest neflamapimod's potential as a promising treatment for DLB, offering hope for altering the disease's trajectory. This is particularly notable given that no drug has been approved in the U.S. specifically for DLB. The successful outcomes from the extension phase are similar to results from the earlier Phase 2a study, further validating the drug’s therapeutic potential.

CervoMed is enthusiastic about completing the full 32-week extension phase and engaging with regulatory bodies to discuss the advancement of neflamapimod into Phase 3 trials. The company aims to explore further regulatory approval processes, underscoring the drug's promise as a treatment for DLB.

The RewinD-LB study, supported by a grant from the National Institute on Aging, represents a significant step forward in addressing the unmet needs in DLB treatment. CervoMed, with its focus on developing innovative treatments for neurological disorders, continues to advance its efforts with neflamapimod, potentially offering new hope for patients and their families affected by this challenging condition.