Australian company Firebrick Pharma ASX:FRE) has announced its Phase 2 trial of NASODINE NASAL SPRAY in COVID-19 achieved its primary endpoint.
The primary endpoint was the reduction in viral load of SARS-CoV-2 over four days, based on the culturable virus from the throat and nasal swabs.
Firebrick, founded in 2012, said NASODINE treatment resulted in a 100 per cent reduction by day four, compared with 48 per cent for placebo.
“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 in South Africa 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 company said the small number of subjects meant that it was not possible to detect statistically significant outcomes on the secondary endpoints, including the impact on COVID symptoms and the number of days to a RAT‑negative test, assessed over five days from the start of treatment.
“While COVID-19 may be behind us, it will not be the last global pandemic,” said Professor Peter Friedland, the Firebrick'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 said it is not planning further COVID-19 studies or intending to pursue regulatory approval for NASODINE use in COVID-19. However, it said it expects to continue undertaking 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.”