OXFORD, England– Oxford BioDynamics, Plc (AIM: OBD, the Company), a biotechnology company developing precision medicine tests for immune health based on the EpiSwitch® 3D genomics platform, announces the initial results from an interim analysis conducted for the REFINE-ALS prospective trial. The results from a subset of data, highlight the blood-based EpiSwitch prognostic stratification of patients with fast progressing Amyotrophic Lateral Sclerosis (ALS). The Phase 4 REFINE-ALS trial (NCT04259255)[1] is a prospective, multicenter study sponsored by Mitsubishi Tanabe Pharma America (MTPA) designed to identify biomarkers that could serve as quantifiable, biological and non-clinical measures of Edaravone’s pharmacodynamic effect in ALS. To date, in the U.S., RADICAVA and RADICAVA ORS have been used to treat over 8,000 patients, with over 1.1 million days of therapy, and have been prescribed by nearly 2,000 HCPs[2].
ALS, also known as Lou Gehrig’s disease in the US and motor neuron disease (MND) in the UK, is a terminal disorder that attacks nerve cells that control voluntary muscle movements, like chewing, walking, and breathing, usually leading to death from respiratory failure in 3-5 years[3]. Some patients exhibit fast disease progression, with shorter (<15mo) overall survival. Currently, diagnosis of ALS averages 12 months from the onset of symptoms as there are no definitive, clinically validated measures available. This delay can have a significant impact on the timely treatment of patients, while also limiting the recruitment of early-stage patients to clinical trials.
The EpiSwitch platform was chosen for its ability to prognose at time zero, from a blood sample, which ALS patients are likely to have a fast or slow-progressing disease, before starting Radicava treatment[4].
Dr. Gustavo A. Suarez Zambrano, VP of Medical Affairs at MTPA, the US subsidiary of Mitsubishi Tanabe Pharma, said: “We are encouraged by these initial findings. The EpiSwitch platform, as part of other biomarker analyses being conducted in REFINE ALS, will allow us to examine clinically meaningful systemic biomarkers in the REFINE-ALS clinical trial, and enhance our understanding of the role that Radicava® (Edaravone) might play in treating ALS.”
Dr. James Berry, Director, NCRI, Massachusetts General Hospital, shared interim analysis data from the study at the 2022 Annual Northeast Amyotrophic Lateral Sclerosis (NEALS)[5]
“We are very interested in investigating the biological impact of RADICAVA on this complex disease by using cutting-edge, meaningful biomarkers,” said Dr. Berry. “Non-invasive EpiSwitch biomarkers could enable us to successfully predict slow vs fast progressors at baseline and compare the positive impact of treatment between REFINE-ALS and ANSWER-ALS cohorts, further confirmatory data will be analyzed in the coming future.”
The non-invasive EpiSwitch 3D genomics platform continues to deliver clinically meaningful patient stratifications of high efficacy – including applications in neurology, oncology, and autoimmune indications.
OBD is the commercial pioneer and technology leader in the discovery, validation, and monitoring of systemic 3D genomic biomarkers within a liquid biopsy (blood). Today the Company’s EpiSwitch CiRT Test (Checkpoint inhibitor Response Test), launched in February 2022, is in clinical use in the US for the accurate prognosis of response to Immune Checkpoint Inhibitor therapy.
Dr Alexandre Akoulitchev, FRSM, OBD CSO said: “We are delighted with the initial interim results reported about the use of EpiSwitch in the REFINE-ALS trial. Robust clinical biomarkers based on liquid biopsy have been long predicted to change the practice of medicine, and if proven, could become part of medical standards in XXI century.”
References
[1] ClinicalTrials.gov. Radicava® (Edaravone) Findings in Biomarkers From ALS (REFINE-ALS), updated 8 Aug 2022. https://clinicaltrials.gov/ct2/show/NCT04259255
[2] Mitsubishi Tanabe Pharma America, Inc. MTPA Presents Interim Data from REFINE-ALS Biomarker Study at 21st Annual NEALS Meeting, 2 Nov 2022. https://www.prnewswire.com/news-releases/mitsubishi-tanabe-pharma-america-presents-interim-data-from-refine-als-biomarker-study-at-21st-annual-neals-meeting-301666169.html
[3] Swinnen, B., Robberecht, W. The phenotypic variability of amyotrophic lateral sclerosis. Nat Rev Neurol 10, 661–670 (2014). https://doi.org/10.1038/nrneurol.2014.184
[4] Oxford BioDynamics PLC. Oxford BioDynamics notes first patient enrolled in ALS biomarker study sponsored by Mitsubishi Tanabe Pharma America, 25 Oct 2019. https://otp.tools.investis.com/clients/uk/oxford_biodynamics_plc/rns/regulatory-story.aspx?cid=2040&newsid=1339083
[5] Proceedings of the 21st Annual Meeting of NEALS Consortium. Interim Analysis of the Radicava/Edaravone Findings in Biomarkers from ALS (REFINE-ALS) Study, Nov 2022. https://onlinelibrary.wiley.com/doi/epdf/10.1002/mus.27729
[6] ALS News Today. Biomarkers May Determine ALS Progression, Edaravone Response, 7 Nov 2022. https://alsnewstoday.com/news/biomarkers-may-help-determine-als-progression-edaravone-response/
[7] RADICAVA and RADICAVA ORS Prescribing Information. Jersey City, NJ: Mitsubishi Tanabe Pharma America, Inc.; 2022.
