Posted: 26 September 2023
Starpharma (ASX: SPL, OTCQX: SPHRY) today announces that it has completed recruitment for the post-market clinical study of its broad-spectrum antiviral barrier nasal spray, VIRALEZE™, in patients with COVID-19 in the UK. Recruitment proceeded rapidly and the study successfully enrolled ~200 patients with laboratory-confirmed COVID-19.
Developed by Starpharma, VIRALEZE™ is an antiviral nasal spray that creates a barrier within the nasal cavity to physically trap and block cold/respiratory viruses. VIRALEZE™ forms a physical moisture barrier between viruses and the nasal mucous membrane that traps and blocks viruses.
Study Overview
The randomised, double-blinded, placebo-controlled clinical study of VIRALEZE™ assesses SARS-CoV-2 viral load in the nasal cavity of patients with COVID-19 while using VIRALEZE™. The primary endpoint of the clinical study is the level of a patient’s viral load over a seven-day treatment period.
The study is also collecting additional information on the ability of VIRALEZE™ to prevent disease progression and worsening of symptoms, and shorten the duration of symptoms in patients with COVID-19. This will build on existing human data for the product.
This study has been led by Dr Stephen Winchester, Consultant Virologist, at St Peter’s Hospital NHS Foundation Trust in the UK, which has also successfully completed other studies of nasal sprays in people with COVID-19. The VIRALEZE™ clinical trial design was based on other clinical studies of topical nasal sprays and followed extensive specialist clinical advice and literature review. In non-clinical studies conducted at Scripps Research, treatment with VIRALEZE™ achieved a greater reduction in viral load in mice challenged with SARS-CoV-2 omicron virus than these other nasal sprays.
This post-market clinical study of VIRALEZE™ will generate valuable clinical data on the antiviral performance of VIRALEZE™ in patients with COVID-19. The resulting data will support ongoing marketing and commercial activities, building on the extensive in-market experience with the product. The study will also provide additional clinical safety and efficacy data to satisfy the new European medical device regulations, which will apply to products of this category from mid-2024. Starpharma and its commercial partners have registered VIRALEZE™ in more than 35 countries, including the UK and Europe.
Dr Jackie Fairley, CEO, Starpharma, commented:
“We are pleased with the high level of interest in the VIRALEZE™ post-market clinical study. Many people in the UK and elsewhere are still grappling with COVID-19, as evidenced by the rapid recruitment, and new strains are continuing to emerge. A broad-spectrum antiviral barrier nasal spray, such as VIRALEZE™, has the potential to play an important role globally. We look forward to sharing the results once available. We extend our sincere appreciation to Dr Winchester and the Research and Development team at St Peter’s Hospital in the UK, as well as the participants for their valuable contribution to this study.”
Starpharma will release the results of this post-market clinical study following data and statistical analyses, and anticipates this will be during Q4 CY23.
VIRALEZE™ Antiviral Nasal Spray
Developed by Starpharma, VIRALEZE™ is a topical nasal spray that physically traps and blocks multiple cold/respiratory viruses in the nasal cavity. VIRALEZE™ is applied in the nose where it forms a physical moisture barrier between viruses and the nasal mucous membrane that traps and blocks virus.
Starpharma and its commercial partners have registered VIRALEZE™ in more than 35 countries, including the UK and Europe, and it is available in certain markets online. Product claims may differ by market. Starpharma markets VIRALEZE™ via commercial arrangements in countries in Europe, Asia, and the Middle East. VIRALEZE™ is not approved for use or supply in Australia.
View or download the ASX Announcement (PDF) here.
