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Starpharma Announces Results from Its VIRALEZE Clinical Safety Study08/16/2021 | 08:29pm
Starpharma announced results from its VIRALEZET 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 VIRALEZET 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. The study was a randomised, double-blind, placebo-controlled clinical investigation of the safety, tolerability and pharmacokinetics of multiple applications of VIRALEZET antiviral nasal spray in healthy volunteers. The primary objective of the study was to assess the safety and tolerability of VIRALEZET 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 VIRALEZET 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 VIRALEZET 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 (VIRALEZET 10%; Placebo 10%), nasal congestion (VIRALEZET 6.7%; Placebo 20%), nose bleed (epistaxis) (VIRALEZET 10%; Placebo 10%) and headache (VIRALEZET 13.3%; Placebo 10%). Compliance with the product use requirements was extremely high (mean 99.9% for VIRALEZET and 100% for placebo; or 99.9% across both VIRALEZET 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 VIRALEZET 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.
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