On Aug. 24, 2020, Innovation Pharma reported receiving additional data from a U.S. Regional Biocontainment Laboratory (RBL) based on ongoing in vitro testing supporting Brilacidin as a potential treatment for SARS-CoV-2, the novel coronavirus responsible for COVID-19.

In a new experiment at the RBL in a human lung epithelial cell line, Brilacidin, when directly incubated with the live (or wild type) virus, was shown to inhibit the virus by 50 percent (the IC50 value) at a mid-nanomolar concentration, while remaining non-cytotoxic to cells at high micromolar concentrations—establishing a SI for Brilacidin greater than 300 in this lung cell line. Additionally, this new testing in the human lung cell line showed Brilacidin’s IC90 value to be in the low micromolar range.

Based on public information, a vast majority of other drugs being evaluated as COVID-19 treatments, including repurposed drugs, have SIs that are much lower than that achieved by Brilacidin. Moreover, according to a recent screening of 5,632 compounds, including 3,488 compounds that have undergone clinical stage testing across 600 indications, only 19 compounds were identified as having an IC50 in the nanomolar (<1µM) range, as Brilacidin achieved, when tested against SARS-CoV-2.

Brilacidin has now exhibited robust in vitro anti-SARS-CoV-2 efficacy at low concentrations, well below already established clinically-achievable concentrations based on pharmacokinetics observed in the Company’s Phase 2b clinical trial of Brilacidin in Acute Bacterial Skin and Skin Structure Infections.

In other news, the Company is preparing to expedite planned clinical testing of Brilacidin for COVID-19, including identification of clinical trial sites. Interactions with the Food and Drug Administration, through its Coronavirus Treatment Acceleration Program, are anticipated to begin early September, along with the selection of a Contract Research Organization to implement the Brilacidin for COVID-19 clinical trial. Lastly, the manufacturing of Brilacidin intravenous (IV) drug product is expected to produce an amount in excess of what is estimated to be required for the Company’s planned Phase 2 clinical trial, allowing for extra IV drug product to support potential additional COVID-19 clinical testing.