Nasodine Nasal Spray phase 3 clinical trial : Firebrick Pharma completes 82% patient recruitment
Firebrick Pharma, an ASX-listed pharmaceutical company, announced that it has successfully enrolled 160 subjects in the confirmatory phase 3 clinical trial of Nasodine Nasal Spray as a potential treatment for the common cold.
This enrollment figure represents approximately 82% of the final recruitment target for the trial.
The clinical trial, which commenced in 2022, aims to recruit a total of 196 subjects who have early-stage colds and are confirmed to have a viral infection (excluding SARS-CoV-2) through PCR testing. These subjects constitute the primary endpoint population for the trial, known as the Intent-to-Treat infected (ITTi) population.
During the initial phase of the Nasodine Nasal Spray phase 3 clinical trial, which ran from May 3, 2022, to October 31, 2022, a total of 224 subjects with colds were recruited, at an average rate of 8.7 subjects per week. Among them, 100 subjects, accounting for 45% of the total, were found to be virus-positive.
The trial was then temporarily paused over the summer period and resumed on March 21, 2023.
Since its reopening, the Nasodine Nasal Spray phase 3 clinical trial has made significant progress in enrollment, with an additional 113 subjects joining in the past 10 weeks, averaging 11.3 subjects per week. Among these newly enrolled subjects, 60, or 53%, were confirmed to be virus-positive. This brings the total number of ITTi subjects to 160.
The findings from this phase 3 clinical trial will serve as crucial support for Firebrick Pharma’s international regulatory submissions for Nasodine, including seeking approval in European markets.
Firebrick Pharma remains committed to advancing the development of Nasodine Nasal Spray and hopes that the trial results will pave the way for a potential breakthrough in treating the common cold, benefiting individuals worldwide.
Dr Peter Molloy — Firebrick Pharma Executive Chairman said: “Both the overall recruitment rate and the virus-positivity rate are significantly higher than we achieved in 2022,” said As a result, the weekly ITTi recruitment has gone up from 3.9 subjects in 2022 to 6.0 subjects in 2023, an increase of 55%.
“We are now very confident about reaching our target of 196 subjects well before the end of the current cold season. As previously telegraphed, we expect to announce headline results during the third quarter.”