WAKEFIELD, MA – July 13, 2020 (GLOBE NEWSWIRE) Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, today provides perspectives on the planned clinical trial testing of Brilacidin, administered intravenously (IV), for the treatment of COVID-19. The exigencies of the pandemic coupled with Brilacidin’s multiple therapeutic properties – its anti-viral SARS-CoV-2 activity, its anti-inflammatory potential to abate the COVID-19 associated cytokine storm, as well as its proven anti-bacterial properties – have the Company working vigilantly to advance Brilacidin into human trials against COVID-19 during fourth-quarter 2020.
As previously released, manufacturing steps are now underway to prepare Brilacidin for COVID-19 clinical trial use, including the sourcing of materials and making of sterile IV drug product. In parallel to these manufacturing efforts, the Company has drafted a study protocol toward initiating a planned Phase 2 trial of Brilacidin for COVID-19. This proposed study has two active treatment arms evaluating different IV dosing regimens in hospitalized patients with COVID-19. The ongoing in vitro testing at independent laboratories of Brilacidin against SARS-CoV-2, in which Brilacidin has shown consistently robust results in human and animal cell lines, is helping to inform trial design.
Given the continuing coronavirus pandemic, and especially in light of surging cases in the United States, the Company is looking to start a clinical trial with Brilacidin for COVID-19 treatment in Q4 2020. This forecast assumes manufacturing is completed, per the manufacturer’s timeline, and a successful Investigational New Drug (IND) application with the Food and Drug Administration.
“The spread of COVID-19 only seems to be getting worse, a truly worrisome trend, with reports of possible reinfection occurring more frequently,” noted Leo Ehrlich, Chief Executive Officer of Innovation Pharmaceuticals. “We continue to work diligently, engaged now in preclinical testing activities, as the world so desperately needs a solution for this pandemic. Getting Brilacidin into the clinic to help treat COVID-19 patients continues to be a primary focus of the Company and our hope is that Brilacidin will be an integral part of the solution.”
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.