Australian Pharmaceutical company Firebrick Pharma (ASX:FRE) has recruited its first patient for a confirmatory Phase 3 trial of its Nasodine Nasal Spray as a treatment for the common cold.
With the cold season moving into full swing, the trial is well placed to recruit subjects over the coming months and move Nasodine towards TGA approval and launch in Australia.
?This is the second Phase 3 trial for Nasodine and we are excited to take what we believe will be the final step towards the launch of Nasodine in Australia, and to lay the pathway for international approval and commercialisation,? said Firebrick Executive Chairman, Dr Peter Molloy.
The product is manufacturing-ready and Firebrick?s manufacturing partner in Australia has the capacity to produce 1 million units a week to service the Australian and export markets.
?Nasodine is a first-in-class nasal spray medicine that actually targets the viral cause of the common cold, where colds start ? in the nose,? said Dr Molloy.
The aim of the trial is to confirm the clinical efficacy of Nasodine treatment (3 sprays per nostril, 4 times daily for 5 days) as a common cold treatment.
The primary endpoint of the trial will be overall cold severity in people confirmed to have a viral cold. Overall cold severity will be measured using the Global Severity Score (GSS) from the WURSS-21 (Wisconsin Upper Respiratory Symptom Survey, 21 item), an internationally validated and accepted tool for measuring and reporting the impact of treatments on cold symptoms and severity.
?GSS is the same metric we used in our first Phase 3 trial, against which we saw a clear clinical benefit of Nasodine, especially in those who had confirmed viral infection,? said Dr Molloy.
The trial is taking place at 3 sites in Australia and 2 in South Africa, to recruit up to 450 adults with early cold symptoms.
The first site to recruit patients has been in Adelaide, with Victorian and South African sites planned to come online over the next month. Trial recruitment at all sites is expected to be completed by October this year.
Background about the trial
The pivotal Phase 3 trial is a double-blinded, randomised, placebo-controlled Phase 3 trial, titled: ?Confirmatory Phase III study of Nasodine Nasal Spray (povidone-iodine 0.5%) as a symptomatic treatment for early stage common cold in the natural setting.? The short title is: ?Nasodine for Symptomatic Treatment of Infective Colds? (NASO-STOIC).?
The Company previously completed a Phase 3 trial for the common cold in 2019 at sites in Adelaide and Brisbane.
?Key learnings from the first Phase 3 trial have enabled us to move forward into this current trial with confidence,? said Dr Molloy. ?This time, we will use GSS as the primary endpoint and select subjects in the primary endpoint population who have a confirmed viral cold, are recruited earlier post symptom onset and have stronger cold symptoms at the time of enrolment. It was on GSS and in each of these groups in the first Phase 3 trial that Nasodine demonstrated the greatest impact.?
The Company recently announced the commencement of a Phase 2 trial of Nasodine in COVID-19 in South Africa (ASX Announcement 26 April, 2022).
?In our prospectus for ASX listing in January this year, we stated our intention to undertake a Phase 2 trial in COVID-19 and a Phase 3 trial for the common cold,? said Dr Molloy. ?Both trials are now underway, which is an outstanding achievement.?
Details about registering for the common cold trial can be found at http://commoncoldstudy.com.