On 23 November 2020, the FDA granted fast track designation to AB201 (a selective inhibitor of tissue factor) for treating coronavirus disease 2019 (COVID-19) and COVID-related coagulopathy. This small recombinant protein selectively inhibits tissue factor that has been demonstrated to play a crucial role in the inflammatory response linked with viral-induced infections. The data indicate that the investigational therapy possesses anti-inflammatory, antiviral, anticoagulant effects.

This potent tissue factor inhibitor could combat coronavirus and its related stimulation of the coagulation system and other aspects of the immune system response. It can be promisingly effective in addressing the influence of viral infections from multiple pathways and may positively affect the clinical recovery of individuals hospitalized due to coronavirus infection.

This designation is aided by data from phase I and II trials of AB201 in about 700 patients for other clinical indications, including studies for preventing arterial and venous thrombosis, where it displayed suppression of the tissue factor pathway and displayed good tolerability at therapeutic doses.

In December 2020, a phase IIb trial (ASPEN-COVID-19) of AB201 will be started in about 100 subjects hospitalized with coronavirus, with topline and significant data anticipated in the second quarter of the year 2021. This fast track designation for the tissue factor inhibitor development program is a vital acknowledgement of the critical requirement for treating hospitalized COVID-19 individuals, whether efficacious vaccines are available or not.