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FDA Grants IND Approval for Phase 2 Clinical Trial of Innovation Pharmaceuticals’ Brilacidin for Treating COVID-19
• Brilacidin’s potent in vitro inhibition of the Washington and Italian strains of SARS-CoV-2 support its potential to inhibit emerging coronavirus mutations (variants), such as those in the United Kingdom, Denmark and South Africa
• 120-patient trial to be conducted at U.S. and international clinical sites
• Primary endpoint time to sustained recovery through Day 29
WAKEFIELD, MA – December 21, 2020 (GLOBE NEWSWIRE) Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company developing Brilacidin, a Host Defense Protein (HDP) mimetic representing a new class of drug with antiviral, anti-inflammatory and anti-bacterial properties, is pleased to announce that the U.S. Food and Drug Administrations (FDA) has approved the Company’s Investigational New Drug (IND) application to proceed with initiation of a Phase 2 clinical trial of Brilacidin in hospitalized patients with COVID-19.
Brilacidin has been shown in vitro to be effective against different SARS-CoV-2 strains (Washington and Italian), as well as multiple human coronaviruses, making it less likely to be affected by emerging mutations (in the United Kingdom, Denmark and South Africa) and further differentiating the drug from other COVID-19 treatments in development today.
With its unique HDP mimetic properties, Brilacidin has potential to exert antiviral activity across SARS-CoV-2 variants. The sudden emergence of highly contagious new variants of the coronavirus illuminates the urgent need for drugs, like Brilacidin, with a different mechanism of action from current antivirals to get this resilient virus under control.
The Phase 2 clinical trial is a randomized, double-blind, placebo-controlled, multi-national, multi-center study expected to enroll approximately 120 patients with moderate-to-severe COVID-19. The trial’s primary endpoint is time to sustained recovery through Day 29 based on the National Institute of Allergy and Infectious Diseases (NIAID) Adaptive COVID-19 Treatment Trial (ACTT) clinical status ordinal scale. The Company will now complete site initiation visits and contracts to add additional clinical sites to the study.
“It’s clear from comments of infectious disease experts like Dr. Anthony Fauci and recent news reports on emerging COVID-19 variants that we are not out of the woods yet with the coronavirus, by any stretch of the imagination. Even with vaccines starting to be rolled-out, it is going to be many more months for them to reach the masses and potentially years before vaccines are available worldwide,” commented Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. “There is now and will be into the foreseeable future a real need for new therapeutics to treat people who contract the infection. We have great hopes Brilacidin will emerge as a novel therapeutic to help fight the global pandemic.”
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 established safety and efficacy data on over 460 subjects, thereby potentially enabling it to rapidly help address the novel coronavirus crisis. Laboratory 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-1ß, TNF-a 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. A preprint supporting Brilacidin’s COVID-19 treatment potential can be downloaded at the link below.
• Brilacidin, a COVID-19 Drug Candidate, Exhibits Potent In Vitro Antiviral Activity Against SARS-CoV-2
https://www.biorxiv.org/content/10.1101/2020.10.29.352450v1.full
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/
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