- Firebrick Pharma (FRE) recruits the first patient under its phase two clinical trial in South Africa for the Nasodine Nasal Spray in COVID-19 management
- In 2021, a pilot human study in South Africa showed that a single Nasodine dose, using four sprays per nostril, led to a 79 per cent reduction in viral shedding within one hour
- The primary aim of the trial is to show that frequent Nasodine applications, every two hours up to eight times a day, over three days, leads to significant reduction in nasal shedding
- A phase three trial will likely need to be undertaken prior to gaining regulatory approval for the management of COVID-19
- Firebrick ends the day 1.09 per cent in the red with shares trading at 45.5 cents
Firebrick Pharma (FRE) has recruited the first patient under its phase two clinical trial in South Africa for the Nasodine Nasal Spray in COVID-19 management.
Up to 210 COVID-positive patients will be recruited to achieve a target treatment population of 144 subjects who will be confirmed to be shedding the SARS-CoV-2 virus.
The study is titled “Reduction of nasal shedding of SARS-CoV-2in COVID-19 positive patients by the use of Nasodine Nasal Spray” and is randomised and placebo-controlled.
In 2021, a pilot human study in South Africa showed that a single Nasodine dose, using four sprays per nostril, led to a 79 per cent reduction in viral shedding one hour after the dose.
The primary aim of the trial is to show that frequent Nasodine applications, every two hours up to eight times a day, over three days, leads to a significant reduction in nasal shedding of SARS-CoV-2.
Secondary aims include whether Nasodine treatment reduces the number of days to a negative RAT test and increasing the percentage of subjects who have cleared the virus from the upper respiratory tract within five days.
A phase three trial will likely need to be undertaken prior to gaining regulatory approval for the management of COVID-19.
“If the trial demonstrates that the Nasodine regimen reduces or eliminates viral shedding, it could point to a potentially important role for Nasodine treatment in anyone who has been recently diagnosed with COVID-19,” Executive Chairman Dr Peter Molloy said.
“While secondary to our focus on the common cold, this Phase 2 COVID-19 trial is important because it may provide proof-of-principle for the reduction of SARS-CoV-2 nasal viral load in patients who are shedding the virus.
“Demonstrating that an agent kills a virus in the laboratory is one thing; proving that it translates clinically is a big step, which we are now taking.”
Firebrick has ended the day 1.09 per cent in the red with shares trading at 45.5 cents.