FIREBRICK Pharma Limited has provided an update on the progress of its Phase 3 clinical trial for Nasodine Nasal Spray, as a treatment for the common cold.
The study, which commenced in 2022, aimed to recruit 196 subjects with early-stage colds who are confirmed by a PCR to have a viral infection (other than SARS-CoV-2).
These subjects represent the primary endpoint population for the trial, referred to as the ITTi.
As at 30 May, 160 ITTi subjects had been enrolled, representing 82% of the final recruitment target.
In 2022, the trial ran for 26 weeks from 03 May to 31 Oct and recruited 224 subjects with colds (8.7 per week), of whom 45% (100) were virus-positive.
The trial was then paused over the summer period and reopened on 21 Mar this year.
In the 10 weeks since it reopened, another 113 subjects have already been enrolled (11.3 per week), of whom 53% are virus-positive (60), bringing the total ITTi subjects to 160, the company said.
"Both the overall recruitment rate and the virus-positivity rate are significantly higher than we achieved in 2022," said Dr Peter Molloy, Executive Chairman of Firebrick.
"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," said Molloy.
"We expect to announce headline results during the third quarter."
The trial results will be used primarily to support international regulatory filings for Nasodine, including a European approval submission.
Pictured (L-R): Firebrick Pharma's co-founders Dr Peter Molloy and Dr Stephen Goodall.
The above article was sent to subscribers in Pharmacy Daily's issue from 01 Jun 23
To see the full newsletter, see the embedded issue below or CLICK HERE to download Pharmacy Daily from 01 Jun 23
