· Emerging mutations to the coronavirus are unlikely to affect Brilacidin’s ability to inhibit the virus
· Brilacidin currently is being evaluated in a Phase 2 clinical trial in hospitalized COVID-19 patients
WAKEFIELD, MA – March 2, 2021 (GLOBE NEWSWIRE) Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, today announced the publication of a peer-reviewed scientific article—Brilacidin Demonstrates Inhibition of SARS-CoV-2 in Cell Culture—in the journal Viruses.
The article is accessible at the link below.
· Bakovic, A.; Risner, K.; Bhalla, N. (et al). Brilacidin Demonstrates Inhibition of SARS-CoV-2 in Cell Culture. Viruses 2021, 13, 271; https://doi.org/10.3390/v13020271
https://www.mdpi.com/1999-4915/13/2/271/
In the paper, Brilacidin was shown to exert potent inhibitory effects on SARS-CoV-2 in cell culture by decreasing viral load in different cell types, including ACE2 positive human lung cells, and, importantly, in both the Washington and Italian strains of the coronavirus. Testing of Brilacidin against additional SARS-CoV-2 strains is planned.
Already with over a half-million deaths in the U.S. and over two million deaths worldwide attributable to COVID-19, the emergence of more transmissible and more virulent variants of the novel coronavirus is causing added concern. Last week, the U.S. FDA issued industry guidance outlining recommendations for developing vaccines, drugs and diagnostic tools based on variants.
Brilacidin’s ability to disrupt viral integrity suggests Brilacidin likely is not subject to resistance developing due to coronavirus variants—unlike current COVID-19 treatments, such as monoclonal antibodies and convalescent plasma, and first-generation COVID-19 vaccines. This mechanism of action supports Brilacidin as a clearly differentiated antiviral in clinical development.
Leo Ehrlich, Chief Executive Officer of Innovation Pharmaceuticals, commented, “Infectious disease experts have noted the next phase in the global fight against COVID-19 will be in developing potent antivirals that directly act on the SARS-CoV-2 virus—which is what Brilacidin has been shown to do in pre-clinical studies. The Company looks forward to continuing its scientific collaborations with government and academic researchers to further inform Brilacidin’s treatment potential as a broad-spectrum antiviral drug candidate targeting coronaviruses, regardless of mutation or strain.”
Currently, Brilacidin is being evaluated in a global Phase 2 clinical trial in hospitalized COVID-19 patients.
Brilacidin and COVID-19
Brilacidin, which has received FDA Fast Track designation for the potential treatment of COVID-19, 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 established safety and efficacy data on over 460 subjects, thereby potentially enabling it to rapidly help address the novel coronavirus crisis. Pre-clinical testing at independent laboratories supports Brilacidin’s antiviral ability to safely and potently inhibit SARS-CoV-2, and multiple strains of human coronaviruses (H-CoVs). In a human lung cell line against SARS-CoV-2, Brilacidin achieved a Selectivity Index of 426. A molecular screening study of 11,552 compounds also supports Brilacidin as a promising novel coronavirus treatment. Brilacidin antiviral research to date has been limited to laboratory-based experiments. Additional pre-clinical and clinical data support Brilacidin’s inhibition of 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. Collectively, these data support Brilacidin as a unique 3-in-1 combination—antiviral, immuno/anti-inflammatory, and antimicrobial—COVID-19 therapeutic candidate, with pan-coronavirus treatment potential. The Company has initiated a randomized, placebo-controlled Phase 2 clinical trial of Brilacidin for treatment of COVID-19 in moderate-to-severe hospitalized patients.