Mitsubishi Tanabe Pharma America Inc. (MTPA) announced virtual poster presentations reviewing the Phase 4 REFINE-ALS biomarker study in people with amyotrophic lateral sclerosis (ALS), including an overview of biomarker assays utilized in the study as well as COVID-19 mitigation strategies deployed through protocol amendments. Details were presented as part of the Motor Neurone Disease Association (MNDA) 32nd International Symposium on ALS/MND, being held virtually December 7-10. The REFINE-ALS study, conducted in collaboration with the Massachusetts General Hospital (MGH) Neurological Clinical Research Institute (NCRI), is designed to identify and measure specific biomarkers and clinical assessments in up to 300 people with ALS in the U.S. who have begun treatment on RADICAVA® (edaravone). The study is utilizing the expertise of multiple specialty laboratories to assess biomarker samples for oxidative stress, inflammation, neuronal and muscle injury. Biomarkers are measured prior to initiating treatment with RADICAVA, at the start of treatment, and at pre-specified time points throughout the 24-week study period (six cycles of treatment). Protocol amendments to the study were implemented in January 2021, giving patients the ability to consent to participate virtually, with the option to utilize telemedicine and home health agencies instead of being required to go to the hospital or in-office visits. Trained nurses are responsible for collecting blood and urine samples during study visits to the clinic or at the participant's home, with these samples being processed and shipped for same-day delivery to a central collection company.