· Preliminary data shows Brilacidin’s Selectivity Index (SI), a ratio that compares a drug’s cytotoxicity and antiviral activity, to be greater than 300 in a human lung epithelial cell line
· Brilacidin’s SI is higher than the SIs of a vast majority of other antiviral drugs being evaluated as COVID-19 treatments; a high SI means a drug is more likely to be safe and effective in the clinic
WAKEFIELD, MA – August 24, 2020 (GLOBE NEWSWIRE) Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, reports today 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.
“The latest Brilacidin in vitro efficacy results against SARS-CoV-2 are outstanding,” noted Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. “Selectivity Index is arguably the most important measure to compare the antiviral efficacy between experimental drugs and this new data suggests Brilacidin is in an elite group of anti-coronavirus candidates. For a point of reference, a SI greater than 100 is considered exceptional. Unlike thousands of other compounds and drugs under consideration as COVID-19 treatments, Brilacidin is demonstrating remarkably consistent and potent anti-SARS-CoV-2 activity in RBL testing, suggesting Brilacidin has tremendous potential as a COVID-19 treatment. We are actively planning to get Brilacidin into human testing as fast as possible, following necessary approvals and set-up procedures.”
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 (https://ghddi-ailab.github.io/Targeting2019-nCoV/preclinical/), 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 (https://www.researchsquare.com/article/rs-23951/v1), 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.
Global COVID-19 Cases and Mortality
An online tool tracking COVID-19 cases and mortality, both in the U.S. and globally, can be found on the Company’s website (http://www.ipharminc.com), and at the following link:
https://ipixcovid19tracker.com/
For researchers and institutions interested in collaborating on Brilacidin for COVID-19, please send inquiries to: covid19@ipharminc.com
Brilacidin and COVID-19
Brilacidin is one of the few drugs targeting COVID-19 that has been tested in human trials (a total of 8) for other clinical indications, providing an established safety and efficacy database on over 460 subjects, thereby potentially enabling it to rapidly help address the novel coronavirus crisis. Ongoing laboratory testing conducted at a U.S. Regional Biocontainment Laboratory (RBL), and at a Public Health Research Institute (PHRI), supports Brilacidin’s antiviral ability to safely inhibit SARS-CoV-2 in both human and animal cell lines. A molecular screening study of 11,552 compounds also supports Brilacidin as a promising novel coronavirus treatment. Additional pre-clinical and clinical data support Brilacidin’s potential to inhibit IL-6, IL-1β, TNF-α and other pro-inflammatory cytokines and chemokines, which have been identified as central drivers in the worsening prognoses of hospitalized COVID-19 patients. Brilacidin’s robust 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 unique 3 in 1 combination—antiviral, immuno/anti-inflammatory, and antimicrobial—anti-COVID-19 therapeutic candidate.