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Biopharmaceutical company ARCA announced today that AB201, a potential treatment for COVID-19, has been fast-track certified by the U.S. Food and Drug Administration (FDA).
plans to launch AB201 Phase IIb Clinical Trials (ASPEN-COVID-19) in approximately 100 COVID-19 inpatients in December 2020, with top-line trial data expected in the second quarter of 2021.
according to the FDA's Fast Track Guidelines document, the Fast Track Program aims to facilitate and accelerate the review of new drugs designed to treat serious or life-threatening diseases and demonstrate the potential to meet medical needs.
AB201 is an effective tissue factor (TF) selective inhibitor, a small recombinant protein that is being developed as a potential treatment for RNA virus-related diseases, initially focusing on COVID-19.
has been identified as playing an important role in combating the inflammatory response to viral infections and virus transmission.
its unique mechanism of action to make AB201 anticoagulant, anti-inflammatory and anti-viral properties, so it is possible to effectively address the impact of a variety of ways on viral infections.
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