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How it Works
VIRALEZE™ acts locally in the nasal cavity where respiratory viruses that cause colds, flu, and more severe respiratory illness, such as COVID-19, first attach and start to multiply.
Astodrimer sodium in VIRALEZE™ is not absorbed into the bloodstream.
The nasal cavity is the primary site where SARS-CoV-2 (COVID-19) becomes established, before spreading to the lungs.^
Mucus is naturally produced in the nose and its role is to trap foreign particles (e.g., dust or viruses) and reduce the chance of them infecting cells in the nasal cavity and entering the lungs. The mucoadhesive formula of VIRALEZE™ provides a physical moisture barrier in your nose that hydrates the nasal mucosa for protection against mucosal drying and damage, thereby supporting your body’s natural defenses against viruses.
VIRALEZE™ also contains astodrimer sodium (SPL7013), which is antiviral and has been shown in laboratory studies to physically trap and irreversibly inactivate viruses†, providing a further physical barrier to respiratory viruses.
^Hou, Y.J., et al. SARS-CoV-2 reverse genetics reveals a variable infection gradient in the respiratory tract. Cell 2020, 182(2), 429-446.e14. https://doi.org/10.1016/j.cell.2020.05.042
†Paull, J.R.A. et al. Virucidal and antiviral activity of astodrimer sodium against SARS-CoV-2 in vitro. Antiviral Research 2021, 191, 105089. https://doi.org/10.1016/j.antiviral.2021.105089.
Paull, J.R.A. et al. Protective effects of astodrimer sodium 1% nasal spray formulation against SARS-CoV-2 nasal challenge in K18-hACE2 mice. Viruses 2021, 13(8), 1656. https://doi.org/10.3390/v13081656.
Astodrimer sodium (SPL7013) acts by blocking the interaction between the SARS-CoV-2 viral “spikes” and the human cells the virus is seeking to infect.
“Spike” proteins on the surface of these viruses that come into contact with VIRALEZE™ are trapped by astodrimer sodium. This interaction is “virucidal” – the virus is irreversibly blocked and can no longer infect cells.
This mechanism provides a physical barrier to respiratory viruses in the nasal cavity. The trapped and inactivated viruses are eliminated naturally through the nasal mucus.
†Paull, J.R.A. et al. Virucidal and antiviral activity of astodrimer sodium against SARS-CoV-2 in vitro. Antiviral Research 2021, 191, 105089. https://doi.org/10.1016/j.antiviral.2021.105089.
Paull, J.R.A. et al. Protective effects of astodrimer sodium 1% nasal spray formulation against SARS-CoV-2 nasal challenge in K18-hACE2 mice. Viruses 2021, 13(8), 1656. https://doi.org/10.3390/v13081656
Antiviral activity for astodrimer sodium (SPL7013) demonstrated in multiple in vitro and in vivo studies.†
Astodrimer sodium has demonstrated antiviral activity against a broad spectrum of respiratory viruses in laboratory studies including:
- SARS-CoV-2 (the coronavirus that causes COVID-19), including Australian, US and European strains, and alpha, beta, gamma, delta, omicron and kappa variants
- MERS-CoV (the coronavirus that causes MERS)
- SARS-CoV (the coronavirus that causes SARS)
- H1N1 (the influenza virus that caused Swine Flu)
- H3N2 (the influenza virus that caused Avian Flu)
- RSV (respiratory syncytial virus)
Astodrimer sodium (SPL7013) has been shown to be virucidal, inactivating >99.9% of SARS-CoV-2 within one minute.†
† Paull, J.R.A. et al. Virucidal and antiviral activity of astodrimer sodium against SARS-CoV-2 in vitro. Antiviral Research 2021, 191, 105089. https://doi.org/10.1016/j.antiviral.2021.105089.
Astodrimer sodium shows significant blocking of virus infection in both pre- and post-infection assays.
Dose-response analysis of SARS-CoV-2 (2019-nCoV/USA-WA1/2020) antiviral activity of astodrimer sodium in Vero E6 cells as measured by infectious virus release. Astodrimer sodium was added to cell cultures 1 hour prior to or 1-hour post-infection.
Proven antiviral activity for astodrimer sodium (SPL7013)
Extensive data on the antiviral and virucidal activity of astodrimer sodium (SPL7013) against SARS-CoV-2 has been generated and is now published in the highly regarded, peer reviewed scientific journal, Antiviral Research.
The data confirm that astodrimer sodium (SPL7013) inhibits infection of host cells by SARS-CoV-2 when it is applied to the cells either before or after exposure to the virus (see Figure 1 below).
The selectivity of SPL7013 for SARS-CoV-2 in these assays was very high (selectivity index up to ~2200), indicating potent antiviral efficacy compared with minimal cellular toxicity. The selectivity index is a measure of therapeutic window.
In vitro testing at the prestigious Scripps Research Institute demonstrated the virucidal activity of astodrimer sodium (SPL7013) inactivating >99.9% of SARS-CoV-2, within one minute1. The virucidal effect was seen within one minute of exposure. The selectivity, or therapeutic index2 of astodrimer sodium (SPL7013) for SARS-CoV-2 is higher than reported for other known antiviral compounds3.
Testing of astodrimer sodium was conducted at The Scripps Research Institute and 360biolabs.
1 Paull, J.R.A. et al. Virucidal and antiviral activity of astodrimer sodium against SARS-CoV-2 in vitro. Antiviral Research 2021, 191, 105089. https://doi.org/10.1016/j.antiviral.2021.105089.
2 Selectivity index is a ratio of antiviral activity to cellular toxicity. The higher the selectivity index, the theoretically safer and more effective a compound would be in humans.
3 Pizzorno, A. et al. In vitro evaluation of antiviral activity of single and combined repurposable drugs against SARS-CoV-2. Antiviral Research, 181, 104878. https://doi.org/10.1016/j.antiviral.2020.104878
Virucidal Assay: Virucidal efficacy of astodrimer sodium (SPL7013) against SARS-CoV-2 (2019-nCoV/USA-WA1/2020) measured by a reduction in mean infectious virus compared with virus control (virus without astodrimer sodium) in Vero E6 cells.
Protective effects of VIRALEZE™ against SARS-CoV-2 in animal challenge model
VIRALEZE™ has been tested in a SARS-CoV-2 challenge model where it demonstrated protection against SARS-CoV-2, reducing viral load by >99.9% (vs. saline control), and significantly reducing levels of pro-inflammatory cytokines.
The study showed that VIRALEZE™ administered nasally reduced viral load by >99.9% (vs. saline control) in the lungs and trachea of animals challenged with SARS-CoV-2. The protective effects of VIRALEZE™ against SARS-CoV-2 in animals are consistent with the previously reported in vitro virucidal activity of SPL7013, which reduces infectious SARS-CoV-2, including the Delta variant, by >99.9% within 30 seconds of exposure.
The results of the in vivo study (conducted at The Scripps Research Institute) have been published in the peer-reviewed journal, Viruses, in a special issue titled, Medical Interventions for Treatment and Prevention of SARS-CoV-2 Infections1.
The model used in this study of VIRALEZE™ is one of the animal models endorsed by the World Health Organisation (WHO) to accelerate the testing of vaccines and therapeutic agents for COVID-192.
1 Paull, J.R.A. et al. Protective effects of astodrimer sodium 1% nasal spray formulation against SARS-CoV-2 nasal challenge in K18-hACE2 mice. Viruses 2021, 13(8), 1656. https://doi.org/10.3390/v13081656.
2 The transgenic mouse model expresses the human angiotensin converting enzyme (hACE2) receptor used by SARS-CoV-2 to infect cells in the human nasal cavity and respiratory tract.
