Nov 19, 2020

SPL7013 shows potent antiviral activity in RSV expanding use for nasal spray

SPL7013 shows potent antiviral activity in RSV expanding use for nasal spray
  • New data generated demonstrates Starpharma’s antiviral nasal spray active (SPL7013) has potent antiviral activity against Respiratory Syncytial Virus (RSV)
  • RSV is a common and very contagious virus that affects the lungs and airways, infecting an estimated 64 million people and causing 160,000 deaths each year globally[1]
  • SPL7013 was effective against RSV when used either before or after exposure of cells to the virus, indicating that the nasal spray would be effective if used before and/or after exposure to the virus
  • This data, generated at a US specialist virology testing laboratory, expands the antiviral spectrum of SPL7013 from previously announced respiratory viruses, including SARS-CoV-2 (the coronavirus causing COVID-19) and influenza
  • Starpharma has formulated SPL7013 into a preventative nasal spray, VIRALEZETM - on track to be commercially available in H1 2021

Melbourne, Australia; 19 November 2020: Starpharma (ASX: SPL, OTCQX: SPHRY) today announced it has completed additional testing showing potent antiviral activity of SPL7013 against human respiratory syncytial virus (RSV). RSV is a common and very contagious virus that affects the lungs and airways. RSV is most problematic in the young and the elderly and those with weakened immune systems, or chronic heart and lung disease, including asthma.[2] More than 177,000 adults are hospitalized and 14,000 of them die due to RSV infection in the US annually.[3] RSV is also one of the viruses responsible for the common cold.

Despite extensive efforts over many years, there are few strategies available to prevent or treat RSV infection. There are no vaccines for RSV, and few therapeutics available to treat RSV infections. Like influenza, RSV frequently mutates making vaccine development particularly challenging.[4]

The data demonstrating the antiviral activity of SPL7013 against RSV further expands the antiviral spectrum of SPL7013 in respiratory viruses, which already includes SARS-CoV‑2 (the coronavirus that causes COVID-19) and H1N1 influenza. Starpharma is also testing SPL7013 against other respiratory viruses with the intention to add these to the product claims as data becomes available.

SPL7013 has been formulated into a preventative antiviral nasal spray, VIRALEZE™, which is now in the late stages of development and on track to be commercially available in H1 2021, with first launches expected to occur in Europe and other regions to follow. VIRALEZE™ is an easy to use preventative nasal spray, which can be stored at room temperature and will not require refrigeration. Recent consumer research for VIRALEZE™ conducted in Europe indicates strong, wide-ranging appeal, particularly in regard to the broad spectrum antiviral activity including COVID-19 and influenza.

The expanded range of viruses against which SPL7013 is active further strengthens the product proposition for VIRALEZE™ as well as its potential use in the management of both endemic viral respiratory diseases and preparedness for future pandemics.

Dr Jackie Fairley, Starpharma CEO, commented: “We are pleased to announce the expanded use of SPL7013 in RSV. RSV is a common virus which has significant morbidity and mortality for the elderly and those with chronic disease. What these results confirm, is that SPL7013 has broad spectrum antiviral activity, and that VIRALEZE™ could play an important role for future pandemic preparedness. The rapid development and commercialisation of SPL7013 as VIRALEZE™ antiviral nasal spray is on track, with the product set to be available in some markets as early as 1H CY2021”.

“SPL7013 is virucidal, inactivating more than 99.9% of SARS-CoV-2, which causes COVID‑19. For every additional virus, like RSV, in which SPL7013 shows activity - builds the commercial opportunity for the product both in endemic respiratory viral infections and potentially for use in future pandemics”, added Dr Fairley.

About Respiratory Syncytial Virus (RSV)

RSV is a common and very contagious virus, that affects the lungs and airways. RSV is most problematic in the young and the elderly and those with weakened immune systems, or chronic heart and lung disease, including asthma.[5] It is one of the leading causes of death of infants worldwide, but is also important in older adults and adults with chronic medical conditions. RSV has been associated with long term respiratory conditions such as chronic bronchitis, asthma, obstructive pulmonary disease and idiopathic pulmonary fibrosis.  It can also result in serious disease in older adults especially those who are frail or have other health problems such as chronic bronchitis and COPD.[6] RSV is also one of the most frequent causes of the common cold and can infect people of all ages.

Study results

Antiviral testing of SPL7013 against RSV was conducted by a US-based, specialised antiviral testing laboratory.

As with other viruses including coronavirus (SARS-CoV-2), SPL7013 showed potent antiviral activity against RSV when applied to the cells before or after exposure to the virus (Figure 1).

In addition, the selectivity index[7] was also very high (up to 790), indicating potent antiviral efficacy with minimal cellular (off-target) toxicity. 

 

Given its mechanism of action, SPL7013 has activity against a broad spectrum of viruses. In addition, in previous antiviral testing, SPL7013 has been shown to be active against multiple drug-resistant strains of viruses including HIV and HSV (herpes simplex virus), and to not select for virus resistant to SPL7013. Therefore, SPL7013 is also expected to be active even if virus mutates, which is an advantage over traditional vaccine approaches which can be overcome by mutations (e.g. annual strain updates required for influenza vaccines).

Previous announcements in relation to Starpharma’s antiviral nasal spray include:

Download: SPL7013 shows potent antiviral activity in RSV expanding use for nasal spray (PDF, 95kb)

[1] https://www.niaid.nih.gov/diseases-conditions/respiratory-syncytial-virus-rsv

[2] https://www.cdc.gov/rsv/factsheet-older-adults.html

[3] https://www.cdc.gov/rsv/about/index.html

[4] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5217795/

[5] https://www.cdc.gov/rsv/factsheet-older-adults.html

[6] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5217795/pdf/zcm277.pdf

[7] 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.

 This contains certain forward-looking statements.