STARPHARMA has announced its Viraleze post-market clinical study showed its SARS-CoV-2 nasal spray reduced viral load in the nose and increased the clearance of key symptoms including loss of smell.
The results announced on the ASX showed that the nasal spray was well-tolerated by patients.
The post-market, double-blind, placebo-controlled clinical study enrolled a total of 222 participants eligible for safety analyses, with 197 of these participants having laboratory-confirmed SARS-CoV-2 infection and eligible for efficacy testing, stated the company.
Participants were randomised in a 1:1 ratio and self-administered Viraleze or a placebo nasal spray four times daily for seven days.
Starpharma stated the results from this study provided significant clinical evidence of the performance of Viraleze in humans that will support regulatory processes for the transition to the new European Medical Device Regulations, which will come into full effect in 2029.
The positive data will also support ongoing marketing and commercial activities for the product.
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, said, "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 well tolerated and demonstrated no increase in side effects compared with the placebo.
"Based on the 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." JG
The above article was sent to subscribers in Pharmacy Daily's issue from 30 Jan 24
To see the full newsletter, see the embedded issue below or CLICK HERE to download Pharmacy Daily from 30 Jan 24
