Concurrently, the Company is prioritizing Brilacidin?s clinical development by taking steps to rapidly advance Brilacidin testing in human trials, including preparations for engaging with regulatory authorities, as the research continues into the drug?s antiviral properties.

Results from initial testing at the RBL showed that Brilacidin had antiviral activity against SARS-CoV-2 in Vero cells, a screening assay using a monkey epithelial cell-line. Proposed further research studies to be conducted at the RBL include:

• Testing Brilacidin?s direct virucidal activity on SARS-CoV-2 in human lung epithelial cells (by preincubating the novel coronavirus with Brilacidin at varying concentrations and times of incubation);

• Obtaining the in vitro concentration of Brilacidin that gives half-maximal response, the EC50 value, in lung epithelial cells;

• Determining impact of multiple dose exposure of Brilacidin on SARS-CoV-2 (assessing potential for achieving greater virus control without inducing toxicity);

• Evaluating time-to-treatment windows as a post-exposure therapeutic (by introducing Brilacidin at 4, 8, and 16 hours post-initial infection, with virus cultures carried forward up to 48 hours);

• Exploring if Brilacidin has synergistic properties with other small molecules that have antiviral activity.

?Brilacidin and COVID-19

Brilacidin is one of the few drugs targeting COVID-19 that has been tested in Phase 2 human trials for other clinical indications, providing an established safety and efficacy profile, thereby potentially enabling it to rapidly help address the emerging worldwide coronavirus crisis. Lab testing conducted at a U.S.-based Regional Biocontainment Laboratory (RBL) supports Brilacidin?s antiviral activity in directly inhibiting SARS-CoV-2 in cellular assays, with a molecular screening study of 11,552 compounds also supporting it as a promising novel coronavirus treatment. Additional pre-clinical and clinical data support Brilacidin?s potential to inhibit the production of IL-6, IL-1?, TNF-a and other pro-inflammatory cytokines and chemokines (e.g., MCP-1), which have been identified as central drivers in the worsening prognoses of COVID-19 patients. Brilacidin?s antimicrobial properties might also help to fight secondary bacterial infections, which can co-present in up to 20 percent of COVID-19 patients. These data collectively support Brilacidin as a particularly promising and unique (3 in 1 combination: antiviral, immune/anti-inflammatory, and antimicrobial) anti-COVID-19 therapeutic candidate.

For researchers and institutions interested in collaborating on Brilacidin for COVID-19, please send inquiries to: covid19@ipharminc.co