Starpharma (ASX:SPL) has announced the results of the post-market clinical study of its Viraleze nasal spray in participants with COVID-19.
The company said Viraleze reduced SARS-CoV-2 viral load in the nose, increased the virus clearance rate from the nose, improved key symptoms of COVID-19, including loss of smell (anosmia), and was well-tolerated.
The post-market, double-blind, placebo-controlled clinical study enrolled 222 participants eligible for safety analyses, with 197 participants having laboratory-confirmed SARS-CoV-2 infection and eligible for efficacy analyses. Participants were randomised in a one-to-one ratio and self-administered Viraleze or a placebo nasal spray four times daily for seven days.
According to Dr Stephen Winchester, consultant medical Virologist at Frimley Health NHS Foundation Trust and principal investigator of the Viraleze clinical study at Ashford and St Peter’s Hospitals NHS Foundation Trust in the UK, “I am very impressed by these clinical data demonstrating the ability of Viraleze nasal spray to accelerate SARS-CoV-2 RNA clearance and recovery from clinically important symptoms such as anosmia in these fully vaccinated participants with COVID-19.
“The positive SARS-CoV-2 RNA clearance outcomes and evidence of clinical benefit in cohorts of older participants indicate that Viraleze could potentially be of significant benefit in people over 45 years of age to support their vaccine responses.
“Viraleze was very well tolerated and demonstrated no increase in side effects compared with the placebo.
“Based on these data, Viraleze, which is a broad-spectrum nasal spray, could have clinical benefit for protection against infection and treatment of individuals, as well as infection control of populations.”
Starpharma’s CEO Cheryl Maley said, “The clinical study on Viraleze has shown positive antiviral efficacy in participants with COVID-19. These results are consistent with Starpharma’s nonclinical studies, which also demonstrated that Viraleze™ protected against infection in a humanised mouse challenge model of COVID-19.
“SPL7013 in Viraleze has also been shown to have virucidal effects against all tested strains of SARS-CoV-2, including recently identified variants, with reductions of over 99.9% of infectious virus in laboratory studies.
"Viraleze has also demonstrated significant antiviral effects in vitro against a wide range of other respiratory viruses, including influenza viruses, respiratory syncytial virus (RSV), and common cold viruses, including human coronaviruses.
"Starpharma is grateful to the Principal Investigator of the study, Dr Stephen Winchester, and the Research and Development team at St Peter’s Hospital in the UK for their efforts in conducting the study, as well as all the participants who took part in the study, for their time and effort in contributing to valuable scientific research.”