CervoMed Unveils Positive Phase 2b Study Results for Dementia Treatment
A new batch of neflamapimod capsules has shown promising results, leading to increased plasma drug concentrations. This also demonstrated significant improvements on the primary outcome measure—the change from baseline in the Clinical Dementia Rating Sum of Boxes (CDR-SB)—showing a strong p-value of less than 0.001 compared to the older capsules and a value of 0.003 versus placebo.
Additionally, outcomes also improved as measured by the Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (CGIC), with a p-value of 0.035 against both previous capsules and placebo.
Notably, there was a decrease in the incidence of falls among participants who received the new neflamapimod capsules compared to both old capsules and placebo controls during this extension phase.
CervoMed Inc. (NASDAQ: CRVO), a clinical-stage company dedicated to developing therapies for age-related neurological disorders, announced these favorable findings from the first 16 weeks of the extension phase of its Phase 2b RewinD-LB study focused on dementia with Lewy bodies (DLB).
“Today marks a breakthrough for individuals affected by DLB and their families. The results highlight how neflamapimod may change the course of DLB treatment as no drugs are currently approved for its management,” stated Dr. James E. Galvin, a leading neurologist involved in the research.
Dr. Galvin continued, “Relying on the insights gained from our studies, in collaboration with the DLB clinical community, we are eager to advance neflamapimod through phase 3 clinical trials and secure regulatory approval.”
The initial phase of the RewinD-LB study showed that earlier formulations of neflamapimod failed to deliver expected plasma concentrations. However, the new batch has yielded higher concentrations, demonstrating a robust relationship to clinical improvements as measured on both primary and key secondary efficacy endpoints. Dr. John Alam, CEO of CervoMed, expressed enthusiasm regarding further phases of the study.
He commented on the remarkable effect size on the CDR-SB, adding that the results align well with earlier studies demonstrating proof-of-concept for neflamapimod as a viable therapeutic option for DLB.
Key Findings from the Phase 2b Study
In total, 159 participants were randomized in the initial double-blind, placebo-controlled phase, with 152 completing it and 149 continuing into the extension phase, all receiving the neflamapimod treatment. Although treatment was open label during this period, participants remained unaware of which batch they were receiving during the earlier phase. Among those continuing, 55 received the old capsules, while 94 switched to the new formulations.
- Of the participants who received old capsules, 87.3% completed the extension, while 91.5% of those on new capsules saw similar completion rates.
- Analyses using a Mixed-effects Model for Repeated Measures provided strong evidence that the new capsules resulted in lower CDR-SB scores, indicating less cognitive decline compared to the old capsules, with a calculated difference of -0.73.
- Additionally, when comparing data from both phases of the trial, new capsules showed a significant benefit over placebo, with a difference of -0.45.
Clinical Global Impression Scores
- At week 8 of the extension, those taking new capsules had improved CGIC scores compared to those on old capsules (4.02 vs. 4.46, p=0.035), pointing to less deterioration.
- A separate analysis also showed that participants receiving new capsules who were previously on placebo scored better on the CGIC (3.94 vs. 4.46, p=0.035).
Safety Measures in Recent Findings
- Safety evaluations indicated comparable tolerability profiles between old and new capsules, revealing no new adverse effects during the extension phase.
- Fewer occurrences of falls were recorded among those taking new capsules versus those on older formulations (7.4% vs. 14.5%).
- Furthermore, the incidence of falls was also significantly lower among participants on new capsules compared to those on placebo during the initial phase.
Pharmacokinetic Insights and Future Directions
Research has shown that plasma drug concentrations were markedly higher with new capsules as opposed to the older versions. It appears that previous lower effectiveness was due to aging capsules impacting dissolution kinetics rather than chemical degradation. CervoMed aims to complete the full 32 weeks of the ongoing study and engage with regulatory bodies to expedite phase 3 discussions following additional positive data.
CervoMed is keenly aware of the evolving landscape in DLB research, understanding the urgency to provide targeted therapies. As the global healthcare community leans toward innovative treatment approaches, the results of this clinical study bring hope for patients suffering from this challenging neurological condition.
Frequently Asked Questions
What is neflamapimod?
Neflamapimod is an investigational drug designed to treat dementia with Lewy bodies by inhibiting specific kinases linked to neurodegeneration.
What were the key findings of the RewinD-LB study?
The study showed that new neflamapimod capsules improved cognitive measures and reduced fall rates among participants compared to older capsules and placebo.
How does DLB impact patients?
Patients with DLB experience cognitive decline and motor deficits, affecting their daily lives and increasing care needs, often leading to higher healthcare costs.
What can be expected from future studies?
Further phases of the study aim to gather more comprehensive data to support regulatory approvals for neflamapimod in treating DLB.
What safety measures were implemented in the study?
Participants were monitored for side effects and fall incidents, with findings showing no new safety concerns linked to the new capsules.
