The Food and Drug Administration (FDA) has granted Fast Track designation to AB201 (ARCA biopharma, Inc) for the treatment of coronavirus disease 2019 (COVID-19) and associated coagulopathy.

AB201 is a small recombinant protein that selectively inhibits tissue factor (TF), which has been shown to play a role in the inflammatory response associated with viral infections. Data suggest that the investigational therapy has anticoagulant, anti-inflammatory and antiviral properties. According to the Company, AB201 could potentially treat COVID-19 and its associated activation of the coagulation system as well as other aspects of the immune response.

The designation is supported by data from phase 1 and 2 studies of AB201 in over 700 patients for other indications, including clinical studies for the prevention of venous and arterial thrombosis, where it demonstrated inhibition of the TF pathway and was well tolerated at therapeutic doses. The Company will initiate a phase 2b trial (ASPEN-COVID-19) of AB201 in approximately 100 patients hospitalized with COVID-19 in December 2020, with topline data expected in the second quarter of 2021.

“Fast Track designation for the AB201 development program is an important acknowledgement of the critical need for treatments for hospitalized COVID-19 patients, whether effective vaccines are approved and available or not,” said Dr Michael Bristow, ARCA’s President and Chief Executive Officer, who is also an American Heart Association (AHA) funded COVID-19 investigator.

For more information visit


AB201 development as a potential treatment for COVID-19 receives US FDA Fast Track designation. [press release]. Westminster, CO: ARCA biopharma, Inc; November 23, 2020.