Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced eight presentations at the European Network to Cure Amyotrophic Lateral Sclerosis (ENCALS) 2024 Annual Meeting being held in Stockholm, Sweden from June 17-20, 2024.
The presentations will cover a wide range of translational research in amyotrophic lateral sclerosis (ALS), including the extension study results from the pivotal Phase 3 trial (MT-1186-A01) that contributed to RADICAVA® (edaravone) U.S. approval.
Final data from the global, multi-center, double-blind, Phase 3b study MT-1186-A02 will be presented, including the post-marketing study evaluated an investigational once-daily dosing regimen of RADICAVA ORS® (edaravone) compared to the FDA approved on/off regimen administered in 28-day cycles in people with ALS over 48 weeks. In addition, full results will be presented from the Phase 3 open-label safety extension (MT-1186-A03) of RADICAVA ORS over 96 weeks.
Results will be presented from an interim analysis of the prospective, observational, longitudinal, multi-center Phase 4 REFINE-ALS study, designed to identify predictive and pharmacodynamic biomarkers to measure the effect of edaravone in ALS, as well as evaluate clinical outcomes in real-world settings. In addition, data will be presented evaluating treatment patterns, clinical outcomes and survival of RADICAVA-treated people living with ALS in the ALS/Motor Neuron Disease (MND) Natural History Consortium (NHC) registry.
