Australian company Firebrick Pharma (ASX:FRE) has announced that its Phase 2 COVID-19 trial of Nasodine Nasal Spray has closed for recruitment.
The company said nasal swabs collected from all subjects had been forwarded to a specialist virology laboratory in the Netherlands for viral culture analysis. The results are expected to be available in June 2023.
The trial (designated FBP-007) commenced in April 2022 at five clinical sites in South Africa.
The study is assessing the extent to which frequent daily Nasodine application can stop or reduce shedding of the COVID-19 virus (SARS-CoV-2) in patients with early COVID-19 symptoms.
The protocol involved the application of Nasodine (or a placebo nasal spray) eight times per day over 2.5 days for a total of 20 doses. This compares with the four times daily over five days regimen used in the common cold clinical trials conducted by Firebrick to date.
“This frequent dosing was designed to definitively assess the potential for Nasodine to rapidly eliminate the SARS-CoV-2 virus from the nose, which is believed to be the primary site of infection and shedding,” said Firebrick executive chairman Dr Peter Molloy.
“In addition, we hope the study results will support the safe use of more frequent dosing of Nasodine.”
The company said the trial was originally intended to enrol up to 210 subjects. It has been abridged to 39 subjects due to the ongoing low number of new COVID-19 cases in South Africa.
“We are confident that the reduced number of subjects will not impact our ability to detect statistically robust outcomes on the primary and secondary endpoints,” said Dr Molloy.
“COVID-19 will not be the last viral pandemic we face,” said Dr Molloy. “If the trial results are positive, Nasodine could be at the front line of future pandemic defence strategies.”