CervoMed Releases Topline Data from RewinD-LB Phase 2b Trial in Lewy Body Dementia Patients

CervoMed Inc., a company listed on NASDAQ as CRVO and dedicated to creating treatments for age-related neurological disorders, recently shared the top results from its RewinD-LB Phase 2b clinical trial. This trial aimed to evaluate the efficiency of neflamapimod in treating dementia with Lewy bodies (DLB). Unfortunately, the trial did not achieve statistical significance in its primary measure, which was the change in the Clinical Dementia Rating Sum of Boxes (CDR-SB), nor in its key secondary measures, including the Timed Up and Go (TUG) test, a Neuropsychological Test Battery, and the Clinician’s Global Impression of Change (CGIC).

A primary issue identified was the failure to reach target plasma drug concentrations during the double-blind phase, potentially affecting the results. Despite the setback, CervoMed's CEO, John Alam, expressed that while they were disappointed, they remain optimistic about neflamapimod's potential for treating DLB. The company plans to scrutinize the clinical and pharmacokinetic data from the trial to understand the results better and explore future development paths. As part of this, they are pausing preparations for a Phase 3 trial pending further analysis. The open-label extension trial's initial 16-week data, expected in the first half of 2025, is anticipated to provide valuable insights.

Despite the trial's outcomes, neflamapimod showed a favorable safety and tolerability profile, consistent with previous studies, as no new safety concerns were identified. Kelly Blackburn, CervoMed's Senior Vice President of Clinical Development, extended gratitude to the participants, their families, and all involved in the trial, emphasizing the importance of their contributions.

The comprehensive data from the double-blind phase is expected to be available in January 2025, with additional data from the open-label extension anticipated by late second quarter of 2025. CervoMed plans to announce further presentations on the RewinD-LB trial data after the first 16 weeks of the open-label extension and a thorough analysis of all data.

DLB, affecting about 700,000 people in both the U.S. and the European Union, is the third most prevalent neurodegenerative disease following Alzheimer’s and Parkinson’s. Patients experience protein deposits called Lewy bodies in nerve cells, impairing cognitive and motor functions. DLB patients face higher healthcare costs, longer hospital stays, and reduced quality of life, with their caregivers experiencing significant stress compared to those caring for Alzheimer’s patients. Currently, no DLB treatments are approved by the FDA or European Medicines Agency, although some drugs are in development. The existing standard care involves cholinesterase inhibitors, which are more suited for Alzheimer’s and have limited effectiveness in addressing DLB's motor symptoms.

Neflamapimod is an investigational orally administered small molecule designed to inhibit the alpha isoform of p38MAP kinase. Initial preclinical studies showed it could reverse synaptic dysfunction, and earlier trials demonstrated significant improvements in DLB symptoms compared to placebo, particularly in early-stage patients. The RewinD-LB trial, informed by previous findings, was the first to enroll exclusively early-stage DLB patients, who represent over half of the diagnosed population at any time.

The 16-week randomized, double-blind, placebo-controlled trial involved 159 early-stage DLB patients across 43 sites in the U.S., the UK, and the Netherlands. It was funded by a $21.3 million grant from the National Institutes of Health’s National Institute on Aging. CervoMed continues its mission to develop treatments for neurological disorders, with neflamapimod showing potential in addressing synaptic dysfunction, a reversible aspect of neurodegenerative processes.