COVID-19 Inactivated by SPL7013 Nasal Spray - Scripps Research Institute

asx news Sep 14, 2020

Published by Anthony Di Pizio

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This news by StarPharma Holdings (ASX:SPL) hit the market today. The below is a direct quote from the announcement:

''New data generated at Scripps Research Institute in the US shows that Starpharma's antiviral nasal spray active (SPL7013) is virucidal, inactivating more than 99.9% of SARS-CoV-2, the virus that causes COVID-19''

Note that SPL7013 is also referred to as astrodrimer sodium. 

This appears to have confirmed the company's assumptions from prior testing:

The potency of SPL7013 was evident when used either before or after the exposure of cells, meaning the nasal spray could be used either before or after exposure to the virus. 

This round of antiviral testing comes after promising announcements from the company in both April and August which we'll cover below. It was conducted in the laboratory of Professor Philippe Gallay at the internationally recognised Scripps Research Institute in the US.

The active component (SPL7013) is already being used in a range of Starpharma's products sold worldwide, meaning there could be an opportunity for fast-tracked regulatory approval which the company says they're working on. 

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Timeline

April 2020

  • On April 15th, Starpharma announced that its SPL7013 antiviral dendrimer showed significant activity against SARS_CoV-2. 
  • They noted that the active component (SPL7013) is already used and marketed in a range of Starpharma's products being sold across Australia, UK, Europe, Canada, Japan and SE Asia. SPL7013 already has regulatory approval in these places for those products.
  • SPL7013 had already shown potent antiviral activity against a wide range of viruses including HIV, herpes simplex, hepatitis B, HPV, zikavirus and adenovirus, so testing against COVID-19 was a logical decision. 
  • Testing began in February via a specialist antiviral testing laboratory in Melbourne, Australia, where it was found that the compound was highly active against the coronavirus causing COVID-19. 

August 2020

  • Starpharma repurposed SPL7013 as an antiviral nasal spray with advanced progress. Formulations developed, a manufacturer selected and pilot manufacture undertaken. 
  • Additional antiviral testing completed, confirming potency against SARS-CoV-2 with data submitted for peer review and available on bioRXiv. 
  • Discovered that potent activity of SPL7013 against SARS-CoV-2 was evident when used either before or after exposure to the virus.
  • Regulatory documents compiled in preparation for submission, with an expedited regulatory pathway confirmed for important markets including Europe.

From the announcement:

''The selectivity of SPL7013 for SARS-CoV-2 in these assays was very high (selectivity index3 up to ~2200), indicating potent antiviral efficacy compared with minimal cellular toxicity. The selectivity index is a measure of therapeutic window. The high selectivity index of SPL7013 compares very favourably with the selectivity index against SARS-CoV-2 reported in the literature of 279 for remdesivir and 172 for chloroquine. In an assay to detect virucidal activity, SPL7013 also rendered SARS-CoV-2 inactive and prevented infection when it was mixed with the virus prior to adding to cells.''

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September 2020

  • Scripps Research Institute in the US shows that Starpharma's antiviral nasal spray active (SPL7013) inactivated more than 99.9% of SARS-CoV-2.
  • Results reiterated findings from previous tests regarding use before or after exposure to the virus.
  • Starpharma is rapidly advancing development, regulatory, manufacturing and commercialisation activities. The company anticipates expedited approval and expects to have the product ready by the first half of calendar year 2021. 

Our Opinion

This news is huge, given that data already exists at a preclinical and clinical level so regulatory approval should be more straightforward than in most cases. We are disappointed by the company's suggestion that the product may not be ready until the end of this year (in time for H1, 2021) because it may have been beaten to market by a vaccine by then. 

As the world desperately searches for a solution to this virus, we really do need something yesterday. We're watching multiple developments at the moment and we will bring you anything else we find interesting. 

We await further updates from the company.

ADS Capital does not cover Starpharma (ASX:SPL) and this article does not represent an endorsement. 

If you need some guidance in the markets, you should consider investing with us. We provide stock recommendations (Australian and US companies) and walk you through the buy, the sell and what you should be looking at next. 

You can view all of Starpharma's announcements here.

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