- Nasodine Phase 3 Common Cold trial has closed recruitment following the enrolment of 500 subjects
- Readout of headline efficacy results expected by end-September
Firebrick Pharma is pleased to announce that its Phase 3 trial of Nasodine® Nasal Spray in the treatment for the common cold has successfully 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 primary endpoint for the trial is the impact of Nasodine (versus placebo) on overall cold severity in enrolled subjects who tested PCR-positive for a respiratory virus (excluding SARS- CoV-2), the ITTi population. Based on progressive viral testing results, the ITTi population is projected to be at least 255 subjects (50% of all subjects), which is 130% of the target ITTi for the trial (196 subjects).
The study protocol, objectives and endpoints have been fully described in the Company’s previous announcements (see ASX announcements 3 May 2022, 23 November 2022). The Phase 3 trial is intended to support registration of Nasodine in Europe and international partnering of Nasodine. The EU registration dossier is scheduled to be filed in January 2024 and the Company expects this schedule to be met.