Firebrick Pharma Limited’s (ASX:FRE) Phase 2 trial of Nasodine Nasal Spray in COVID-19 has achieved its primary endpoint.
The primary endpoint was the reduction in viral load of SARS-CoV-2 over four days, based on culturable virus from throat and nasal swabs. Nasodine treatment resulted in 100% reduction by day four, compared with 48% for placebo and this difference was statistically significant (p=0.028).
To put this in perspective, the treatment regimen ran over two and a half days and then on the fourth day, 100% of the Nasodine subjects were clear of virus,” said Firebrick Executive Chairman, Dr Peter Molloy.
The study was conducted in South Africa and recruited 39 subjects, 23 of whom were culture-positive and qualified for the primary endpoint population.
“Achieving statistically significant results in viral shedding, in spite of the small number of subjects, is what we hoped for, and Nasodine did not disappoint,” said Dr Molloy.
“It shows that Nasodine emphatically reduces viral shedding in a clinical setting. This is an important finding that extends the body of evidence about Nasodine’s mechanism of action in treating upper respiratory infections,” added Dr Molloy.
The small number of subjects meant that it was not possible to detect statistically significant outcomes on the secondary endpoints, which included the impact on COVID symptoms and the number of days to a RAT-negative test, assessed over five days from start of treatment.
“While COVID-19 may be behind us, it will not be the last global pandemic,” said Professor Peter Friedland, the company’s Chief Medical Officer. “A nasal spray that can rapidly clear pandemic viruses from the nasal passages could be extremely valuable in protecting frontline healthcare workers in the next pandemic.”
The company is not planning further COVID-19 studies or intending to pursue regulatory approval for Nasodine use in COVID-19. However, it expects to continue to undertake research that extends the evidence for Nasodine as a therapeutic intervention for upper respiratory infections, especially the common cold.
“Our focus remains on Nasodine as a treatment for the common cold,” said Dr Molloy. “In that regard, we look forward to closing our current Phase 3 trial and announcing the results this quarter.”
