• Starpharma’s antiviral dendrimer, SPL7013, has been shown to have significant activity against SARS-CoV-2^[1] (coronavirus), which causes COVID-19
• SPL7013 is the active component in Starpharma’s range of marketed VivaGel^® products^[2] (VivaGel^® BV and the VivaGel^® condom), already sold in Australia, UK, Europe, Canada, Japan and South East Asia
• Given that products containing SPL7013 are already approved in the above markets, the existing preclinical and clinical data on file creates the opportunity to fast-track the development and commercialisation of SPL7013-based product(s) for COVID-19

Melbourne, Australia; 15 April 2020: Starpharma (ASX: SPL, OTCQX: SPHRY) today announced that its proprietary VivaGel^® active, astodrimer sodium (SPL7013), has been shown in laboratory studies to have significant antiviral activity against the coronavirus that causes COVID-19 (coronavirus disease). SPL7013 inhibited the infection of cells with the SARS-CoV-2 virus and the finding was validated by replicate testing against a positive control compound, remdesivir (Gilead), which is considered a leading candidate for the treatment of COVID-19. The finding was also significant given that SPL7013 was reported to be the best performing test compound against SARS-CoV-2 in the laboratory’s assay to date. With these positive results, Starpharma is evaluating product concepts and formulation options for SPL7013, which may have potential applications in the prevention and management of COVID-19.

Given SPL7013 is already approved as the active component of two marketed VivaGel^® products (VivaGel^® BV and the VivaGel^® condom) and these products have regulatory approval in Europe, Canada, Japan, Australia and South East Asia, Starpharma anticipates it should be possible to fast-track certain aspects of the development path for products targeted at COVID‑19. The Company will now commence additional short-term preclinical studies, and in parallel, will confirm the pathway with regulatory authorities. A new patent has also been filed following receipt of these coronavirus results. Starpharma retains rights to COVID-19 related products resulting from these findings and as such they would be the subject of new commercial licences and would not impact existing VivaGel^® licences.

The SARS-CoV-2 antiviral testing of SPL7013 was conducted under contract by Melbourne-based 360Biolabs, which has developed SARS-CoV-2 assays to support antiviral discovery and development. SPL7013 is one of the first agents tested by 360Biolabs to demonstrate significant SARS-CoV-2 activity.

The VivaGel^® active (SPL7013) has previously been shown to have potent antiviral activity against a wide range of viruses, including HIV, herpes simplex, hepatitis B, HPV, Zika virus and adenovirus. SPL7013 inactivates viruses by blocking the interaction between viral surface proteins and the human cell receptor proteins. As for other viruses inhibited by SPL7013, SARS-CoV-2 infects human cells by using the characteristic viral surface proteins, or “spikes”, to attach to receptor proteins on the surface of human cells.

Dr Jackie Fairley, Starpharma CEO, commented: “Following the emergence of the coronavirus pandemic in February, Starpharma instigated testing of SPL7013 via a specialist antiviral testing laboratory in Melbourne. We are very pleased to find that the compound is highly active against the coronavirus that causes COVID-19 and we are now exploring a number of product opportunities, including a potential preventative application to reduce the risk of infection. Such a product could provide additional personal protection including for those in the frontline of this crisis, such as doctors, nurses and other essential workers, and is in keeping with Starpharma’s strategy to expand commercial applications of our dendrimers. We are very pleased to be in a position to potentially help with the effort in overcoming the current global COVID-19 pandemic.”

About 360biolabs

360biolabs (www.360biolabs.com), is a commercially-focused, ISO-accredited laboratory that offers specialised clinical virology testing, and which has access to specialist Physical Containment (PC) 3 biological facilities. Starpharma thanks Melbourne Health, the Doherty Institute and VIDRL (Victorian Infectious Diseases Reference Laboratory) for providing a sample of SARS-CoV-2 to 360biolabs to facilitate testing.

About VivaGel^® active (SPL7013)

SPL7013 is one of Starpharma’s proprietary dendrimers that is already a component of two approved products, VivaGel^® BV for bacterial vaginosis and the VivaGel^® antiviral condom. These products are approved and marketed in a range of regions/ countries including the UK, Europe, Japan, South East Asia, Canada, Australia and New Zealand.

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

[1]  Severe acute respiratory syndrome coronavirus 2, or SARS-CoV-2, is the virus that causes COVID-19.

[2]  VivaGel BV^® is marketed by Mundipharma as Betafem^® BV Gel (UK), Betadine BV™ (Europe), Betadine™ BV Gel (Asia) and by Aspen Pharmacare as Fleurstat BVgel (Australia and New Zealand). The VivaGel^® condom was launched by Okamoto as VivaGel^® Zero Zero Three (003) (Japan) and by LifeStyles under the Dual Protect^® brand and is pending launch by LifeStyles under the Absolute™ Dual Protection brand in Europe.