Dec 22, 2020
VIRALEZE COVID-19 nasal spray study to commence in January
- Starpharma has now received all necessary approvals to commence its study for VIRALEZE™ with enrolment to commence in early January 2021
- VIRALEZE™ expected to be ready for market in Q1 CY2021 with EU regulatory dossier >90% complete
Melbourne, Australia; 22 December 2020: Starpharma (ASX: SPL, OTCQX: SPHRY) today announced that it has received all necessary approvals to commence its clinical study for VIRALEZE™. The study will commence enrolment of healthy volunteers in Perth in early January 2021 and is expected to be completed in Q1 2021. This study is being undertaken to support commercialisation activities for VIRALEZE™, and is not a requirement to achieve EU product registration.
The double-blind, placebo-controlled, safety, tolerability and pharmacokinetic study of VIRALEZE™ nasal spray will be conducted in 40 healthy volunteers, who will use the product four times a day for 14 days.
Starpharma continues to aggressively pursue an expedited regulatory approval pathway for the product, leveraging the extensive data already available for SPL7013 in VIRALEZE™, and the product will be registered via the CE mark route. The EU regulatory dossier is more than 90% complete and VIRALEZE™ is on track to be registered, and ready for market in Q1 CY2021 (as previously announced on 10 December 2020).
Dr Jackie Fairley, CEO of Starpharma commented: “We continue to make excellent progress towards the launch of this important product, including manufacturing campaigns of VIRALEZE™ early in the new year. Starpharma is working hard to bring this product to market as quickly as possible, in the first quarter of 2021. The worsening situation of COVID-19 in Europe in particular clearly highlights the need for preventative strategies for use alongside PPE and vaccines. Not surprisingly, our recent consumer research in Europe indicates strong demand for VIRALEZE™.”
VIRALEZE™ is an antiviral nasal spray for coronavirus and other viruses such as influenza and respiratory syncytial virus (RSV). VIRALEZE™ is an easy to use preventative nasal spray, which can be stored at room temperature and does not require refrigeration.
VIRALEZE™ contains SPL7013, a broad spectrum antiviral, which is the active in products approved in more than 40 countries and on market in the UK, Europe, Asia, Australia and New Zealand.
SPL7013 has been shown in laboratory studies to be virucidal, inactivating more than 99.99% of SARS-CoV-2 (the coronavirus that causes COVID‑19), and stops infection when applied to cells before or after exposure to the virus.
The broad spectrum antiviral activity of VIRALEZE™ is a compelling differentiating feature and means that the product could have an important role in future pandemics.
Download full announcement: VIRALEZE COVID-19 nasal spray study to commence in January (PDF 71kb)