The Food and Drug Administration (FDA) has granted Fast Track designation to brilacidin (Innovation Pharmaceuticals) for the treatment of coronavirus disease 2019 (COVID-19).
Brilacidin is a first-in-class host defense protein mimetic with antiviral, anti-inflammatory and antibacterial properties. Early data has shown that the investigational drug exerts potent in vitro antiviral activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
“Fast Track designation is well-timed, as we anticipate starting our phase 2 clinical trial in hospitalized COVID-19 patients this month, and should help bring brilacidin to patients faster in these dire times,” Leo Ehrlich, CEO at Innovation Pharmaceuticals.
The randomized, double-blind, placebo-controlled phase 2 trial is expected to enroll approximately 120 hospitalized patients with moderate to severe COVID-19. The primary end point of the trial will be time to sustained recovery through day 29 based on the National Institute of Allergy and Infectious Diseases Adaptive COVID-19 Treatment Trial (ACTT) clinical status ordinal scale.
For more information visit ipharminc.com.
1. Innovation Pharmaceuticals’ brilacidin for the treatment of COVID-19 receives FDA Fast Track designation. [press release]. Wakefield, MA: Innovation Pharmaceuticals; January 14, 2021.
2. FDA grants IND approval for phase 2 clinical trial of Innovation Pharmaceuticals’ brilacidin for treating COVID-19. [press release]. Wakefield, MA: Innovation Pharmaceuticals; December 21, 2020.