As per the notification on 14 January 2020, the FDA has granted fast track designation to brilacidin as a potential treatment for COVID-19. Brilacidin, a first-in-class host defense protein mimetic, has anti-inflammatory, antiviral, and antibacterial properties. Early data has shown that the investigational drug exerts potent in vitro antiviral effect against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

Brilacidin, one of the few drugs targeting coronavirus, has been evaluated in human clinical trials (about 8) for various other therapeutic indications. It yielded established efficacy and safety data on over 460 participants, thus potentially enabling it to promptly aid addressal of the new coronavirus crisis. The lab testing supported the virus-fighting ability of brilacidin to safely and considerably suppress SARS-CoV-2, and other multiple strains of human coronaviruses.

Brilacidin was found to attain a selectivity index of 426 in a human lung cell line against coronavirus. Molecular screening analysis of 11,552 compounds also favors brilacidin as a pivotal novel coronavirus therapy. To date, the antiviral investigation of brilacidin has been limited to lab-based experiments. Further clinical and preclinical data favor brilacidin’s suppression of interleukin-6, interleukin-1β, tumor necrosis factor-α, and other pro-inflammatory chemokines and cytokines, which have been recognized as central drivers in the deteriorating prognoses of hospitalized coronavirus-infected patients.

The promising antimicrobial effects of brilacidin may also aid to combat secondary bacterial infections, which can co-present in about 20% of coronavirus individuals. Overall, these findings favor brilacidin as a unique three in one combination-immuno/anti-inflammatory, antiviral, and antimicrobial SARS-CoV-2 therapeutic candidate, with pan-coronavirus therapeutic potential. This fast track designation is well-timed. In January, the phase II trial is expected to initiate in hospitalized coronavirus-infected patients and will aid to promptly bring brilacidin to these patients.