Firebrick Pharma’s Phase 3 Trial of Nasodine Resumes
- Phase 3 Trial of Nasodine for the common cold reopens on schedule
- All ethics approvals are in place to resume recruitment at all sites
- Recruitment open at 2 Australian sites; 3 South African sites to open next week
- Target completion of recruitment is in July 2023
Firebrick Pharma Limited is pleased to announce that its Phase 3 clinical trial of Nasodine Nasal Spray (“Nasodine”) as a treatment for the common cold has received the necessary ethics approvals to re-open for the 2023 common cold season.
Two clinical sites in Australia are now open for recruitment and three sites in South Africa will be open in the next week. This trial was 50% recruited in 2022 and then paused over the summer months, with the stated goal of re-opening in March 2023 (see ASX announcement 31 October 2022, “Firebrick update on Nasodine Phase 3 trial”).
This target has been achieved. The primary endpoint population for the trial is 196 adult subjects with confirmed viral colds. The trial enrolled 100 subjects with confirmed viral colds in 2022, so the goal in 2023 is to enrol the remaining 96 subjects and then report trial results.
“Nasodine works by killing viruses, so establishing its performance in people with actual viral infections is a pivotal proof of efficacy,” said Firebrick Executive Chairman, Dr Peter Molloy.
“Typically, the common cold season starts in Autumn, so we expect to see recruitment escalate over the next several months and continue through the winter, with trial completion expected in July.”
In Australia, the trial is taking place at Barwon Health (Geelong) and CMAX (Adelaide). Any adult (18+) in Adelaide or Geelong who would like to participate, can find out more information, including eligibility criteria and contact details, via www.firebrickpharma.com/nasodine-common-cold-clinical-trial/