Aug 17, 2021
VIRALEZE™ well tolerated in multiple dose clinical study (ASX Announcement)
- VIRALEZE™ was very well tolerated, with no notable or serious adverse events reported, in clinical safety study
- Results of the clinical safety study confirm that that the dendrimer antiviral in VIRALEZE™, SPL7013, is not absorbed into the bloodstream following nasal application, consistent with extensive previous nonclinical and clinical data
Melbourne, Australia; 17 August 2021: Starpharma (ASX: SPL, OTCQX: SPHRY) today announced results from its VIRALEZE™ clinical safety study demonstrating the product was safe and well tolerated in accordance with the primary endpoint, and also confirming that the dendrimer antiviral in VIRALEZE™, SPL7013, was not absorbed into the bloodstream following nasal application.
The randomised, double-blind, placebo-controlled, safety, tolerability and pharmacokinetic study of VIRALEZE™ was conducted in 40 healthy volunteers who used the product four times a day for 14 days. The product was well tolerated with no notable or serious adverse events reported, and no participants discontinued product use.
The study also confirmed that SPL7013 was not detected in the bloodstream following repeated nasal application. This finding is consistent with previous extensive nonclinical and clinical data showing lack of systemic absorption of SPL7013 following topical application to mucosal membranes.
Dr Jackie Fairley, CEO of Starpharma, commented: “We are pleased to report that VIRALEZE™ was very well tolerated in the study. This additional clinical data adds to the extensive body of evidence for SPL7013, demonstrating its extremely benign safety profile and confirming lack of systemic absorption of SPL7013 in VIRALEZE™. These data further support the suitability of VIRALEZE™ antiviral nasal spray for use in everyday situations as a preventative product where individuals may be at risk of exposure to respiratory viruses. An antiviral nasal spray like VIRALEZE™ is advantageous because respiratory viruses, including SARS-CoV-2, take hold by initially infecting mucosal cells in the nasal cavity, and VIRALEZE™ and SPL7013 form a barrier that traps and irreversibly inactivates viruses before they can infect cells.”
VIRALEZE™ is registered for sale in Europe and India, and available in certain markets via www.viraleze.co. VIRALEZE™ is not approved for sale or supply in Australia. Starpharma is currently negotiating distribution and marketing arrangements for VIRALEZE™ in a number of countries which include India, various European countries and other international regions.
About the study
The study was a randomised, double-blind, placebo-controlled clinical investigation of the safety, tolerability and pharmacokinetics of multiple applications of VIRALEZE™ antiviral nasal spray in healthy volunteers. The primary objective of the study was to assess the safety and tolerability of VIRALEZE™ containing 1% SPL7013 administered nasally four times a day for 14 days. The secondary objective was to determine the extent of absorption of SPL7013 following use of the spray.
The primary endpoint was safety, measured by frequency and severity of adverse events (AEs). The secondary endpoint was blood plasma levels of SPL7013 determined following single and repeated applications of the spray.
The study participants were 40 healthy volunteers aged 19 to 58 years; 30 participants received VIRALEZE™ and 10 received the placebo nasal spray 4 times a day for 14 days. Participants were closely monitored and followed up for 1 week after end of treatment.
The product was very well tolerated with no notable AEs reported, no serious AEs, and no AEs leading participants to stop or withdrawal from use of the product. The AEs that were reported were of lowest grade, or mild, intensity. All events that occurred in more than >5% of participants in the VIRALEZE™ group and considered potentially associated with treatment, were also reported at a similar or higher rate in participants in the placebo group. These were: transient tingling/nasal discomfort (VIRALEZE™ 10%; Placebo 10%), nasal congestion (VIRALEZE™ 6.7%; Placebo 20%), nose bleed (epistaxis) (VIRALEZE™ 10%; Placebo 10%) and headache (VIRALEZE™ 13.3%; Placebo 10%).
Compliance with the product use requirements was extremely high (mean 99.9% for VIRALEZE™ and 100% for placebo; or 99.9% across both VIRALEZE™ and placebo), indicating again the excellent tolerability of the product. There were no clinically significant findings or observations from detailed nasal cavity examinations, and no clinically significant abnormal findings from ECGs or vital sign monitoring.
The study also confirmed that SPL7013 was not detected in the plasma following repeated nasal application indicating there was no absorption into the bloodstream. This finding is relevant because it means that the potential for any systemic effects with VIRALEZE™ is negligible, which is not necessarily the case with all nasal sprays. These data are also consistent with previous extensive nonclinical and clinical data showing that SPL7013 is not absorbed into the bloodstream following topical application to mucosal membranes.
The study was conducted at Linear Clinical Research in Western Australia. Starpharma thanks the site staff and study participants for their contribution to and participation in the study.
VIRALEZE™ Antiviral Nasal Spray
VIRALEZE™ contains SPL7013, which has been shown in laboratory studies to inactivate a broad spectrum of respiratory/cold viruses, including multiple variants of SARS-CoV-2, influenza, RSV, SARS, and MERS. The product is an easy to use nasal spray which can be stored at room temperature. VIRALEZE™ is registered for sale in Europe and India. VIRALEZE™ is not registered for sale or supply in Australia.
SPL7013 is also included in products registered in >45 countries and available for sale in the UK, Europe, Japan, South East Asia, Australia and New Zealand.
Starpharma acknowledges the $1 million in funding for the development of VIRALEZE™ provided by the Australian Government’s Medical Research Future Fund (MRFF) Biomedical Translation Bridge (BTB) Program, with support from UniQuest. Delivered by MTPConnect, the Australian Government's BTB program is a $22.3 million MRFF initiative that provides up to $1 million in matched funding to nurture the translation of new therapies, technologies and medical devices through to proof of concept to turn innovative medical ideas into reality.
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