VIRALEZE - Antiviral Nasal Spray
VIRALEZE™ is an antiviral nasal spray that contains astodrimer sodium (SPL7013), which has been shown in laboratory studies to inactivate a broad spectrum of respiratory viruses, including >99.9% of coronavirus SARS-CoV-2, the virus that causes COVID-19.^
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SPL7013 was originally developed by Starpharma for its antiviral activity and has been shown to block a broad-spectrum of viruses in nonclinical in vitro and in vivo studies (Bernstein et al, 2003; Jiang et al, 2005; Gong et al, 2005; Lackman-Smith et al, 2008; Tyssen et al, 2010; Telwatte et al, 2011; Romanowski et al, 2021).
Starpharma subsequently generated and published laboratory data showing that SPL7013 also inactivates >99.9% of coronavirus SARS-CoV-2 (Paull et al., 2021a).
Starpharma has also published data demonstrating the protective efficacy of VIRALEZE™ antiviral nasal spray against SARS-CoV-2 challenge in vivo in a humanised mouse model of coronavirus infection. The study results 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 Infections (Paull et al., 2021b).
SPL7013 has also been shown in laboratory studies conducted at the Scripps Research Institute to inactivate several SARS-CoV-2 “Variants of Concern”, including the Alpha, Beta, Gamma, Delta and Omicron variants, with testing planned for other variants as they emerge and become available.
In addition, Starpharma announced that SPL7013 was shown in laboratory studies to block human respiratory syncytial virus (HRSV), and to block infection by other pandemic coronaviruses (SARS-CoV, MERS-CoV) and influenza viruses.
SPL7013 is a patented, precisely designed large negatively charged molecule that has been shown to not pass into the bloodstream following topical application to mucosal epithelial surfaces. In VIRALEZE™, SPL7013 is intended to form a barrier locally at site of application in the nasal cavity to physically trap and thereby inactivate respiratory viruses.
Starpharma was awarded development funding for the development and commercialisation of VIRALEZE™ by the Australian Government’s Medical Research Future Fund Biomedical Translation Bridge Program.
VIRALEZE™ is registered for sale in more than 30 countries, including in Europe, Asia, and the Middle East. VIRALEZE™ launched in the UK through LloydsPharmacy, as announced on 25 March 2021 and then in Europe via Starpharma's webstore, as announced on 6 May 2021. VIRALEZE™ has also launched in Vietnam as announced on 3 December 2021. Starpharma is also progressing regulatory activities for a number of markets, including Australia, with the intention of rolling it out across other markets. VIRALEZE™ is not approved for sale or supply in Australia.
SPL7013 is also included in products registered in >45 countries and available for sale in the UK, Europe, Japan, South East Asia, Australia and New Zealand.
VIRALEZE™ Mechanism of Action
VIRALEZE™ is applied to the nasal cavity where respiratory viruses that cause colds, flu, and more severe respiratory illness, first attach and start to multiply.
VIRALEZE™ provides a moisturising and protective barrier in the nose and contains SPL7013, which physically traps and inactivates viruses. SPL7013 has been shown in laboratory studies to inactivate viruses (Paull et al., 2021a).
SPL7013 acts by trapping viruses, and blocking the interaction between virus attachment proteins, or “spikes”, and the human cells viruses are seeking to infect.
“Spike” proteins on the surface of viruses that come into contact with VIRALEZE™ are physically trapped by SPL7013. This interaction is irreversible (“virucidal”) and blocked viruses can no longer infect cells.
The “blocked” viruses are then cleared naturally through the nasal mucus.
The mechanism of action of SPL7013 appears to be not adversely impacted by mutations in the spike proteins of SARS-CoV-2 that make the virus more infectious, as occurred for the Delta strain. Instead, the mutations that make the virus interact more readily with cells and therefore more infectious, may make it more susceptible to trapping and blocking by SPL7013.
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