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ARCA Biopharma Submits IND Application To FDA For AB201 As Potential COVID-19 Treatment

ARCA biopharma Inc. (ABIO) said Monday that it has submitted an Investigational New Drug or IND application with the U.S. Food and Drug Administration or FDA under the Coronavirus Treatment Acceleration Program (CTAP) to evaluate AB201 for the treatment of patients hospitalized with COVID-19.

Pending FDA feedback, ARCA expects to initiate the Phase 2b portion of a sequential Phase 2b/3 clinical evaluation of AB201 as early as the fourth quarter of this year.

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.

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