VIRALEZE™ Antiviral Nasal Spray

VIRALEZE™ has been developed by Starpharma, a world leader in the development of new medical products based on its proprietary dendrimer technology, as an antiviral nasal spray that is intended to provide a moisturising and protective barrier in the nose. VIRALEZE™ also contains astodrimer sodium (SPL7013), which has been shown in laboratory studies to inactivate a broad spectrum of respiratory/cold viruses.

The nasal cavity has been shown to be a primary site where respiratory viruses, including cold viruses and SARS-CoV-2 (the virus that causes COVID-19), become established, before spreading in the body (Hou et al, 2021).

Astodrimer sodium 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 more recently announced the publication of laboratory data showing that astodrimer sodium also inactivates >99.9% of coronavirus SARS-CoV-2 (Paull et al, 2021).

Astodrimer 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 and Delta variants, with testing planned for other variants as they emerge and become available.

In addition, Starpharma announced that astodrimer sodium 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.

Astodrimer sodium is a patented, precisely designed large molecule that has been shown to not pass into the bloodstream following topical application to mucosal epithelial surfaces. In VIRALEZE™, astodrimer sodium is intended to form a barrier locally at site of application in the nasal cavity to trap and 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 Europe and India. VIRALEZE™ launched in the UK through LloydsPharmacy, as announced on 25 March 2021 and then in Europe via Starpharma's www.viraleze.co webstore, as announced on 6 May 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.

Astodrimer sodium is also included in products approved 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 astodrimer sodium (SPL7013), which physically traps and inactivates viruses. Astodrimer sodium has been shown in laboratory studies to inactivate viruses (Paull et al, 2021). 

Astodrimer sodium (SPL7013) acts by trapping viruses, and blocking the interaction between virus attachment proteins, or “spikes”, and the human cells viruses are seeking to infect. 

VIRALEZEMOA

“Spike” proteins on the surface of viruses that come into contact with VIRALEZE™ are physically trapped by astodrimer sodium. This interaction is irreversible (“virucidal”) and blocked viruses can no longer infect cells.

The “blocked” viruses are then cleared naturally through the nasal mucus.

 

Hou, Y.J., et al. 2020. SARS-CoV-2 reverse genetics reveals a variable infection gradient in the respiratory tract. Cell 182(2), 429-446.e14. 
Paull, J.R.A. et al. Virucidal and antiviral activity of astodrimer sodium against SARS-CoV-2 in vitro (2021). Antiviral Research.


For more information: 

Download ASX Announcement: VIRALEZE SPL7013 virucidal (>99.99%) against Delta variant (PDF 520kb) - 27 July 2021

Download ASX Announcement: VIRALEZE UK update (PDF 320kb) - 21 June 2021

Download ASX Announcement: VIRALEZE SPL7013 virucidal against multiple COVID variants(PDF 520kb) - 18 June 2021

Download ASX Announcement: VIRALEZE antiviral nasal spray registered for sale in India (PDF 520kb) - 11 June 2021

Download ASX Announcement: VIRALEZE SPL7013 highly active in UK variant of coronavirus (PDF 520kb) - 1 June 2021

Download ASX Announcement: VIRALEZE™ launches in Europe (PDF 218kb) - 6 May 2021

Download ASX Announcement: VIRALEZE™ now launched by LloydsPharmacy in the UK (PDF 224kb) - 30 March 2021

Download ASX Announcement: VIRALEZE™ to be launched with LloydsPharmacy in the UK (PDF 241kb) - 25 March 2021

Download ASX Announcement: SPL7013 active against other pandemic coronaviruses (PDF 418kb) - 3 March 2021

Download ASX Announcement: VIRALEZE™ antiviral nasal spray registered in Europe (PDF 226kb) - 23 February 2021

Download full announcement: VIRALEZE COVID-19 nasal spray study to commence in January (PDF 71kb) - 22 December 2020

Download full announcement: VIRALEZE™ COVID-19 nasal spray to be ready for market Q1CY21 (PDF 113kb) – 10 December 2020

Download full announcement: SPL7013 shows potent antiviral activity in RSV expanding use for nasal spray (PDF 95kb) – 19 November 2020

Download full announcement: SPL7013 COVID-19 nasal spray virucidal against SARS-CoV-2 (PDF 183kb) – 14 September 2020

Download full announcement: SPL7013 nasal spray for COVID-19 – development update (PDF 267kb) – 25 August 2020

Download ASX Announcement: SPL7013 shows significant activity against SARS-CoV-2 (coronavirus) (pdf file, 69kb) – 15 April 2020