ARCA biopharma, Inc., a company applying a precision medicine approach to developing genetically targeted therapies for cardiovascular diseases, received Fast Track designation from the FDA for AB201 as a potential treatment for COVID-19. The company plans to initiate a Phase 2b clinical trial (ASPEN-COVID-19) of AB201 in approximately 100 patients hospitalized with COVID-19 in December 2020, with topline trial data anticipated in 2Q21.

Fast Track programs are designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.

AB201 is a small recombinant protein being developed as a potential treatment for RNA virus-associated diseases, 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 mechanism of action gives AB201 a combination of anticoagulant, anti-inflammatory and antiviral properties, and therefore the potential to be effective in addressing the impact of viral infections from multiple pathways.

“We believe AB201’s combination of anticoagulant, anti-inflammatory and antiviral effects may favorably impact clinical recovery of patients hospitalized with COVID-19 and look forward to beginning the ASPEN-COVID-19 trial to evaluate AB201’s potential efficacy in this patient population,” said Dr. Michael Bristow, ARCA’s President and Chief Executive Officer.