ARCA biopharma, Inc., a biopharma company applying a precision medicine approach to developing genetically targeted therapies for cardiovascular diseases, has submitted an Investigational New Drug application with the U.S. FDA under the Coronavirus Treatment Acceleration Program (CTAP) to evaluate AB201 for the treatment of hospitalized patients with COVID-19. ARCA anticipates initiating the Phase IIb portion of a sequential Phase IIb/III clinical evaluation of AB201 as early as 4Q20.
AB201 is a small recombinant protein being developed as a potential treatment for RNA virus- associated disease, initially focusing on COVID-19. AB201 is a potent, selective inhibitor of tissue factor (TF), which has been identified as playing a central role in the inflammatory response to viral infections and in the process of viral dissemination. Its unique mechanism of action gives AB210 a combination of anti-coagulant, immuno-modulation and anti-viral properties, and therefore the potential to be effective in addressing the pathologies caused by viral infections from multiple aspects.
Dr. Michael Bristow, ARCA’s President and Chief Executive Officer, said, “This IND submission is a key milestone in the clinical development of AB201. With what we believe to be a strong scientific rationale, safety data from prior human clinical trials in over 700 patients, and a well-defined regulatory pathway, we believe AB201 has potential as a therapeutic treatment for COVID-19, as well as other RNA virus associated diseases.”
