CervoMed Completes Phase 2b RewinD-LB Trial for Early-Stage DLB Treatment

CervoMed Inc. (NASDAQ: CRVO) has announced the completion of the Last Patient Last Visit in its RewinD-LB Phase 2b clinical trial, which is evaluating the potential of neflamapimod in patients with early-stage dementia with Lewy bodies (DLB). The company is set to release topline efficacy and safety data from this trial in December 2024.

John Alam, MD, Chief Executive Officer of CervoMed, expressed the significance of this milestone in their neflamapimod program for DLB. He noted the high level of enthusiasm from clinical sites, trial investigators, and patients, highlighting the substantial unmet need in the DLB patient population, for which no approved treatment currently exists. Dr. Alam mentioned that an impressive 96% of the enrolled patients completed the 16-week double-blind placebo-controlled portion of the study, with 98% of these participants continuing into the open label extension. Additionally, the independent Data Safety Monitoring Board recently reviewed the available safety data and recommended that the study proceed without any modifications. CervoMed is eager to share the topline data in December 2024.

Dr. Alam also highlighted the upcoming Clinical Trials on Alzheimer's Disease (CTAD) conference, where CervoMed will present late-breaking oral presentations discussing plasma biomarker data and their relevance to the ongoing trial. Based on insights from their Phase 2a trial and the baseline characteristics of the patients enrolled in RewinD-LB, Dr. Alam believes they have successfully targeted the appropriate early DLB patient population for the study. These patients have substantial clinical deficits but are still capable of showing improvements in their underlying disease process. With a clinically meaningful primary endpoint, Dr. Alam is confident as they approach the topline readout in December, expecting to demonstrate clinical proof-of-concept for neflamapimod as a specific treatment for DLB patients.

The RewinD-LB study is an ongoing Phase 2b clinical trial, which is randomized, 16-week, double-blind, and placebo-controlled. It evaluates oral neflamapimod (40mg TID) in 159 patients with early-stage DLB. Approximately 50% of the diagnosed DLB patient population at any given time are early-stage patients, who have not yet experienced significant neuronal loss in the hippocampus. Advanced DLB patients, characterized by significant, irreversible neuronal loss in the hippocampus and associated Alzheimer's Disease co-pathology (assessed by plasma ptau181), were excluded from the trial. The primary endpoint of the study is the change in the Clinical Dementia Rating Sum of Boxes, while secondary endpoints include the Timed Up and Go test, a cognitive test battery, and the Clinician’s Global Impression of Change.

Funded by a $21 million grant from the National Institutes of Health’s National Institute on Aging, the RewinD-LB study spans 43 sites, with 32 in the United States, 8 in the United Kingdom, and 3 in the Netherlands. Enrollment for the study was completed in June 2024, and topline data is expected by December 2024. Participants who complete the initial 16-week placebo-controlled phase are eligible to continue in the study under open-label neflamapimod treatment for an additional 32 weeks.

CervoMed Inc. is a clinical-stage company dedicated to developing treatments for age-related neurologic disorders. Their investigational drug, neflamapimod, is an orally administered small molecule that penetrates the brain and inhibits p38 mitogen-activated protein kinase alpha. This drug has the potential to address synaptic dysfunction, a reversible aspect of the underlying neurodegenerative processes in DLB and other major neurological disorders. Currently, neflamapimod is being tested in a Phase 2b trial for early-stage DLB patients.