3 in 1 Combination COVID-19 Therapeutic Launches Late-Stage Study
A Massachusetts-based biopharmaceutical company announced that the U.S. Food and Drug Administrations (FDA) had approved the Company’s Investigational New Drug (IND) application to proceed with initiation of Phase 2 clinical trial of Brilacidin in hospitalized patients with COVID-19.
Brilacidin is a Host Defense Protein (HDP) mimetic representing a new class of drug with antiviral, anti-inflammatory, and anti-bacterial properties, said Innovation Pharmaceuticals.
Brilacidin is one of the few drugs targeting COVID-19 tested in human trials (8) for other clinical indications, providing established safety and efficacy data on over 460 subjects, thereby potentially enabling it to help address the ongoing pandemic rapidly.
Brilacidin has been shown in vitro to be effective against different SARS-CoV-2 strains (Washington, Italian) well as multiple human coronaviruses (H-CoV), making it less likely to be affected by emerging mutations, such as in the United Kingdom, Denmark, and South Africa.
With its unique HDP mimetic properties, Brilacidin has the 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.
“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, CEO at Innovation Pharmaceuticals, in a press statement.
“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.”
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 Adaptive COVID-19 Treatment Trial clinical status ordinal scale.
Laboratory testing at independent laboratories supports Brilacidin’s antiviral ability to safely and potently inhibit SARS-CoV-2 and multiple strains of 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 preclinical and clinical data support Brilacidin’s inhibition of IL-6, IL-1β, TNF-α, and other pro-inflammatory cytokines and chemokines, identified as central drivers in the worsening prognoses of hospitalized COVID-19 patients.
Brilacidin’s robust antimicrobial properties might also help 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.
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