Update on Nasodine Phase 3 trial
- Nasodine Phase 3 common cold trial achieves >50% recruitment
- Trial to be paused over summer and resume in early 2023
Firebrick Pharma is pleased to provide an update on our Phase 3 clinical trial of Nasodine® Nasal Spray in the treatment of the common cold.
As at 31 October, the trial has so far successfully recruited 224 subjects with early-stage colds into the ITT (‘Intent-To-Treat’ population), with an estimated 100 qualifying for the primary endpoint population of those with confirmed viral infection (ITTi)1 , based on PCR of a throat and nasal swab.
This represents at least 51% of the trial’s full recruitment target of 196 subjects in the ITTi. The primary endpoint for the trial is the benefit of Nasodine treatment on overall cold severity2 in the ITTi . In the previous Phase 3 trial, Nasodine produced a statistically significant benefit in the 52 subjects who had confirmed viral infection (see p. 20 of the Company’s Prospectus).
The current Phase 3 trial was designed to support international registration of Nasodine and if completed by mid-2023, the EU application for approval could be filed by the end of calendar 2023. The US application will require a further Phase 3 trial to be conducted in the US.
“The trial protocol has been executed well and we feel confident in the quality and robustness of the study for international regulatory purposes,” said Firebrick Executive Chairman, Dr Peter Molloy.
With summer approaching and to avoid unnecessary trial running costs, Firebrick intends to
pause recruitment at all sites from 1 November 2022 and restart in March 2023, with expected completion of recruitment by mid-year.
“The pause over summer will allow us to review site performance and prepare for optimum
recruitment at all sites as soon as the cold season starts again next year,” he said.
To register your interest to participate in the clinical trial of Nasodine® Nasal Spray for the common cold, please click here.
1 The “ITT i ” (“Intent-To-Treat-infected”) population is to be used for assessment of the primary
endpoint. It comprises any subjects that are PCR-positive for a respiratory virus other than SARS-
CoV-2. The ITT includes all enrolled subjects and is used for assessment of secondary endpoints.
2 Overall cold severity is measured by the Global Severity Score (GSS) from the WURSS-21
(Wisconsin Upper Respiratory Symptom Survey, 21 item), which Firebrick has used in its previous
Phase 2 and Phase 3 studies.