Firebrick Pharma (ASX:FRE) has announced that its Phase 3 trial of NASODINE NASAL SPRAY in the treatment for the common cold has completed recruitment, with 500 subjects enrolled.
“Subject to availability of the complete efficacy data and timely completion of the statistical analysis, we expect to report headline results of the trial by the end of September,” said Dr Peter Molloy, executive chairman of Firebrick.
The company said the primary endpoint for the trial is the impact of Nasodine compared to placebo on overall cold severity in enrolled subjects who tested PCR-positive for a respiratory virus (excluding SARSCoV-2).
The company said the Phase 3 trial is intended to support the registration of Nasodine in Europe and international partnering of the product. The EU registration dossier is scheduled to be filed in January 2024.