VIRALEZE™ antiviral nasal spray

Viraleze

VIRALEZE™ is an easy to use antiviral nasal spray, which can be stored at room temperature and does not require refrigeration.

VIRALEZE™ antiviral nasal spray is registered for sale in Europe, including in the UK and is expected to be available for sale online, direct to European and UK consumers in March 2021 via www.viraleze.co.

VIRALEZE™ contains SPL7013 (astodrimer sodium), 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). SPL7013 has been shown to be virucidal, inactivating >99.9% of SARS-CoV-2 within one minute.

SPL7013 has also been shown in laboratory studies to have activity against other important respiratory viruses including influenza viruses, respiratory syncytial virus (RSV), and other human coronaviruses. Based on the effectiveness of VIRALEZE™ against multiple viruses, including drug-resistant strains, the product is expected to retain activity against the SARS-CoV-2 strains being reported in the UK, South Africa and elsewhere. VIRALEZE™ can be stored at room temperature. The product does not require cold storage or specialised transportation.

The nasal cavity is the primary site where SARS-CoV-2 (COVID-19) becomes established, before spreading to the lungs^. “Spike” proteins on the surface of these viruses that come into contact with VIRALEZE™ are trapped by SPL7013. This interaction is ‘virucidal’ – the virus is irreversibly blocked and can no longer infect mucosal cells, thereby providing a physical barrier to respiratory viruses in the nasal cavity. These “blocked” viruses are then eliminated naturally through the nasal mucus. ^Hou et al., 2020, Cell 182, 429–446

SPL7013 is a patented, precisely designed large molecule that acts locally at site of application with no systemic absorption, meaning it does not enter the bloodstream. SPL7013 is included in products licensed in >160 countries, approved in >40 countries and available for sale in the UK, Europe, Japan, South East Asia, Australia and New Zealand.

VIRALEZE™ could provide an additional line of defence (in addition to conventional PPE and vaccine-based prevention strategies) including for those in the frontline of this crisis, such as doctors, nurses and other essential workers and in crowded and high-risk environments, such as public transport and aged care.

The SPL7013 active is patented by Starpharma and a specific patent application has been filed for its use in VIRALEZE™. The antiviral data have been submitted to a peer reviewed scientific journal for publication and a preprint of the manuscript is available on bioRχiv.[1] . Starpharma is also undertaking commercialisation discussions for VIRALEZE™, having shared product details and supporting technical data with a number of potential partners including global pharmaceutical companies.

Mechanism of action

SPL7013 works by blocking the interaction between viral spike proteins and the human cell proteins. As for other viruses inhibited by SPL7013, SARS-CoV-2 infects human cells by using the characteristic viral spike proteins to attach to proteins on the surface of human cells. SPL7013 acts by blocking the interaction between the viral “spikes” and the human cell the virus is seeking to infect.

MoA

Download ASX Announcement: VIRALEZE™ antiviral nasal spray registered in Europe (PDF 226kb) - 23 February 2020

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

[1] bioRχiv (pronounced “bio-archive”) is a preprint website for biology to allow early access to scientific manuscripts operated by Cold Spring Harbor Laboratory in the US.