Firebrick Pharma is pleased to announce that the Phase 2 COVID-19 clinical trial for Nasodine® Nasal Spray (“Nasodine”) in South Africa has commenced, with the first patient now recruited.
The trial is scheduled to recruit up to 210 adults who are COVID-positive by Rapid Antigen Test (RAT) to achieve a target population of 144 subjects who will be confirmed by viral culture to be shedding SARS-CoV-2 virus (most, but not all people who are RAT-positive, will be actively shedding virus and therefore culture-positive). Depending on patient recruitment, the trial could be completed by August this year.
The study is a randomised, placebo-controlled Phase 2 trial, titled: ‘Reduction of nasal shedding of SARS-CoV-2 in COVID-19 positive patients by the use of Nasodine® (povidone-iodine 0.5%) Nasal Spray.’ The short title for the trial is ‘Nasodine for Elimination of COVID-19 Shedding study’ or ‘NASO-ELOCS’. Details can be found on the SANCTR at: https://sanctr.samrc.ac.za/TrialDisplay.aspx?TrialID=5792
In 2021, Firebrick Pharma sponsored a pilot human study in South Africa, which showed that a single Nasodine dose (4 sprays per nostril, 1.12 mL per dose) led to an overall 79% reduction in viral shedding at one hour after the dose in six COVID-19 patients who were shedding the virus from the nose (https://sanctr.samrc.ac.za/TrialDisplay.aspx?TrialID=5360).
The current trial significantly extends that research by undertaking a multi-dose, placebo-controlled, Phase 2 trial looking at impact on viral load and other outcomes over several days.
The primary aim of the trial will be to show that frequent Nasodine application (every 2 hours, up to eight-times-daily) over three days, leads to a significant reduction in nasal shedding of SARS-CoV-2 virus, compared with a placebo nasal spray.
Secondary aims will include whether Nasodine treatment (compared with placebo) reduces the number of days to a negative RAT and increases the percentage of subjects who have cleared the virus from the upper respiratory tract within 5 days, based on a combined throat and nasal swab.
“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,” said Firebrick Executive Chairman, Dr Peter Molloy.
Prior to gaining regulatory approval for any role in the treatment of COVID-19, Nasodine would likely need to undergo a confirmatory Phase 3 trial in a specific aspect of COVID-19 that is clinically relevant to the management of the disease.
Nasodine has already completed a Phase 3 clinical trial as a treatment for the common cold and Firebrick is preparing to start a second Phase 3 common cold trial this year, in order to support international regulatory approvals, and if the Australian appeal is unsuccessful (ASX announcement 1 March 2022), it will also be used to support approval in Australia.
“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,” said Dr Molloy. “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.”
All published trial details can be found on the South African National Clinical Trials Registry at: https://sanctr.samrc.ac.za/TrialDisplay.aspx?TrialID=5792