That’s the question posed in a recent editorial published by The Lancet, a leading British medical journal: “5 months after WHO declared the SARS-CoV-2 outbreak a global health emergency, the virus continues to beat a concerning and complex path. For much of the globe, the worst may be yet to come.”
A similar sentiment is expressed in an informational video (linked below)—"Why COVID-19 Isn’t Going Away Anytime Soon”—reinforcing just how serious and prolonged the global fight against COVID-19 likely will become.
Complicating an already dire situation even further are growing reports of risk of reinfection due to short-lived antibody responses, calling into question the effectiveness of vaccines in the fight against COVID-19.
Brilacidin, the Company’s lead defensin-mimetic drug candidate, is being developed as a promising COVID-19 therapeutic, already having shown robust and consistent in vitro antiviral activity against SARS-CoV-2, the virus responsible for COVID-19. In one pre-clinical experiment in a human lung epithelial cell line conducted at a U.S. Regional Biocontainment Laboratory (RBL), Brilacidin was shown to inhibit SARS-CoV-2 by up to 97 percent at an efficacious concentration tested, as well as by approximately 90 percent in another similar experiment when tested at an even lower efficacious concentration.
Brilacidin also is showing an ability to inhibit viral entry, a highly desirable mechanism of action as it is the first step in the infection process enabling viruses to be inactivated outside of the cell (see graphic below); whereas most other antiviral drugs impact viral replication only after infection of host cells. Detailed data, based on the ongoing antiviral in vitro testing, is planned to be submitted for peer-review publication.
Brilacidin has been tested in Phase 2 human trials for other clinical indications, providing an established safety and efficacy database on hundreds of human subjects, thereby potentially enabling it to rapidly help address the worldwide coronavirus crisis.
The Company has announced plans targeting the clinical testing of Brilacidin for COVID-19 to commence in Q4 2020. The goal is to get Brilacidin—with its multiple proposed targets and mechanisms of action against SARS-CoV-2, including antiviral, anti-inflammatory and anti-bacterial properties—into the clinic to help treat COVID-19 patients.
Source: Su X, et al. “Protein- and Peptide-Based Virus Inactivators: Inactivating Viruses Before Their Entry Into Cells.” Front. Microbiol. 25 May 2020; also see: Xiu S, et al. “Inhibitors of SARS-CoV-2 Entry: Current and Future Opportunities.” J. Med. Chem. (June 15, 2020); Tiwari V, et al. “Discovering Small-Molecule Therapeutics Against SARS-CoV-2.” Drug Discovery Today (June 20, 2020).