CervoMed Completes Phase 2b Enrollment for Neflamapimod in Lewy Body Dementia Trial

CervoMed Inc. (NASDAQ: CRVO), a clinical-stage company dedicated to developing treatments for age-related neurological diseases, has successfully completed patient enrollment for its RewinD-LB Phase 2b clinical trial. This study is focused on evaluating the efficacy of neflamapimod in individuals diagnosed with dementia with Lewy bodies (DLB).

According to John Alam, MD, CervoMed's CEO, advancements in drug development for major dementias over the past decade have increasingly targeted earlier stages of the disease. Alam highlighted that data from the company’s Phase 2a trial showed a significant treatment response in patients with pure DLB, which was more substantial than in patients displaying Alzheimer's disease (AD)-related co-pathology. This latter group typically represents a more advanced stage of the disease.

Alam noted that the successful completion of patient enrollment signifies the first time a pure DLB patient population has been effectively enrolled in a sufficiently powered clinical trial. This rapid enrollment rate underscores the high level of engagement from clinical trial sites, the efficiency of CervoMed’s clinical team and partners, and the fact that most screened patients did not exhibit AD-related co-pathology based on plasma ptau181 testing. The company anticipates releasing topline data in December 2024, which could potentially lead to the development of the first FDA-approved therapy specifically for DLB.

Kelly Blackburn, Senior Vice President of Clinical Development at CervoMed, emphasized that reaching the enrollment milestone is a significant achievement. Blackburn expressed gratitude to the CervoMed team, trial partners, and especially the patients and their families who participated in the neflamapimod clinical development program. The rapid enrollment after site activation highlights the urgent medical need and patient interest in new DLB treatments.

To be eligible for randomization in the RewinD-LB trial, participants had to meet several criteria: a diagnosis of DLB, a Clinical Dementia Rating Global Score (CDR-GS) of 0.5 or 1.0, and no evidence of AD co-pathology as indicated by plasma phosphorylated tau (ptau181) levels below 2.4 pg/mL. Approximately two-thirds of those tested for ptau181 met the eligibility requirements, with no significant difference between patients with CDR-GS scores of 0.5 and 1.0.

The RewinD-LB Phase 2b trial is a randomized, 16-week, double-blind, placebo-controlled study assessing the effectiveness of oral neflamapimod (40mg TID) in up to 160 patients with very mild or mild DLB. After completing the initial 16-week period, participants can continue in the trial on an open-label basis for an additional 32 weeks. Patients with AD-related co-pathology, as determined by plasma ptau181, are excluded from the study. The primary endpoint is the change in the Clinical Dementia Rating Sum of Boxes. Secondary endpoints include the Timed Up and Go test, a cognitive test battery, and the Clinician’s Global Impression of Change.

Funding for the RewinD-LB study comes from a $21 million grant provided by the National Institutes of Health’s National Institute on Aging. This funding will be distributed over the study duration as costs are incurred. The trial involves 43 sites, including 32 in the U.S., eight in the U.K., and three in the Netherlands. For more details on the study and active clinical trial sites, visit clinicaltrials.gov.