Mitsubishi Tanabe Pharma America, Inc. will conduct a study to identify and measure specific biomarkers in people with amyotrophic lateral sclerosis (ALS). The findings may assist researchers and clinicians in starting the process of validation and the use of biomarkers as quantifiable, biological, non-clinical measures for disease progression and treatment effect of edaravone in people with ALS. Interim data are expected in 2019.
"Biomarker research and discovery may be important in the care for people with ALS," said Atsushi Fujimoto, President, MTPA. "Our goal is to evaluate biomarkers in order to gain insights into how the disease progresses, and to potentially optimize research and treatment."
The 24-week, prospective, observational, longitudinal, multicenter study will evaluate approximately 200 adults with ALS in 30 sites across the U.S. All participants will be newly prescribed commercial RADICAVA® (edaravone) and once enrolled in this study, biomarker and clinical assessments will be obtained prior to initiating RADICAVA, as well as at start of treatment and at pre-specified time points throughout the study. Patient biomarker data and disease progression assessments will be compared to bio-banked natural history of disease samples and disease progression models.
"We are honored that MTPA has chosen Origent Data Sciences, with its progression models, to participate in this study," said Dave Ennist, Chief Science Officer, Origent Data Sciences. "We are eager to see insights from the prospective application of our models, which will be utilized as virtual controls to analyze treatment outcomes and provide insights to support the ALS community."
The study will evaluate the following biomarkers:
- Oxidative stress – 4-hydroxynonenal (4-HNE), 8-Isoprostanes, 3-nitrotyrosine (3NT), 8-hydroxy-2'-deoxyguanosine (8OHdG), urate
- Inflammation – matrix metalloproteinase-9 (MMP-9)
- Neuronal injury and death – neurofilament (Nf) heavy and light chain proteins, urinary neurotrophin receptor p75
- Muscle injury – creatinine
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