Posted: 25 August 2023
How has your winter been? Have you managed to avoid illness like Covid-19, the flu or respiratory viruses associated with the common cold?
Over at Firebrick Pharma (ASX:FRE), it’s spent the winter watching its Phase 2 trial of Nasodine Nasal Spray in Covid-19 achieve its primary endpoint.
Just two days after that success, on August 9, FRE put out another announcement saying its Phase 3 trial of Nasodine Nasal Spray in the treatment for the common cold has successfully completed recruitment, with 500 subjects enrolled.
The countdown is now on with FRE saying it is expecting to report headline results of the Phase 3 trial by the end of September.
Nasodine found to reduce SARS-CoV-2 viral load
The primary endpoint in the Phase 2 trial was the reduction in viral load of SARS-CoV-2, the virus that causes Covid-19, over four days, based on culturable virus from throat and nasal swabs.
Nasodine treatment resulted in 100% reduction by day four, compared with 48% for placebo – and this difference was statistically significant (p=0.028).
The treatment regimen ran over two and a half days and then on the fourth day, 100% of the Nasodine subjects were clear of the virus.
The trial was conducted in South Africa and recruited 39 subjects, 23 of whom were culture-positive and qualified for the primary endpoint population.
Achieving statistically significant results in spite of the small number of subjects is what FRE hoped for and Nasodine did not disappoint, showing it reduced viral shedding in a clinical setting.
FRE is not planning further Covid-19 studies or intending to pursue regulatory approval for Nasodine use in Covid-19 but rather will continue to undertake research that extends the evidence for Nasodine as a therapeutic intervention for upper respiratory infections, especially the common cold.
The company says a nasal spray that can rapidly clear pandemic viruses from the nasal passages could be extremely valuable in protecting frontline healthcare workers in future pandemics.
Achoo! Tackling the common cold
FRE’s trial is believed to have been one of the largest Phase 3 trials of a prospective common cold treatment globally in the last decade.
The trial could be a game changer for what has eluded medical scientists for centuries by reducing duration and severity of symptoms and helping to stop spread of viruses causing the illness.
FRE’s finished recruiting 500 subjects for the Phase 3 trial. The primary endpoint is the impact of Nasodine versus placebo on overall cold severity in enrolled subjects who tested PCR-positive for a respiratory virus (excluding SARSCoV-2), referred to as the ITTi population.
‘The common cold is not a trivial disease… Nasodine has the potential to be a blockbuster OTC product’
Based on progressive viral testing results, the ITTi population is projected to be at least 255 subjects (50% of all subjects), which is 130% of the target ITTi for the trial of 196 subjects.
Headline results from pivotal trial are scheduled in coming weeks. Positive Phase 3 trial results are intended to support registration of Nasodine in Europe and international partnering of Nasodine.
The EU registration dossier is due be filed in January 2024 and FRE are confident the schedule will be met.
Inspired by Betadine to target common cold
Established in 2012 and listed on the ASX in January 2022, FRE was co-founded by renowned Aussie biotech figures Dr Peter Molloy and Dr Stephen Goodall, with the goal of advancing a comprehensive cold treatment.
Molloy, who became well-known for leading Biota which developed the Relenza influenza drug, started his pharmaceutical career at FH Faulding, contributing to Betadine products like the Sore Throat Gargle.
His observation that Betadine effectively treats viral-induced sore throats sparked the idea of creating the world’s first common cold treatment by targeting nasal viral infections.
Goodall, former COO of immune-oncology firm Viralytics, became well-known when Merck acquired the company for $502 million in 2018.
FRE’s innovation and registered trademarked product Nasodine combines povidone and molecular iodine, akin to Betadine’s active ingredient used for infection control in hospitals.
Although the compound’s patent lapsed in 1976, FRE secured patents for using it to combat the common cold and pandemic viral diseases.
Firebrick’s name stems from PVP-I’s colour. For more background on the company read Dr Boreham’s Crucible: A cure for the common cold? Why Firebrick Pharma might pass the sniff test
Stockhead caught up with self-confessed germ buster, FRE co-founder and chairman Dr Peter Molloy, to discuss its progress in treating Covid-19 and what a potential cure for the common cold means for medicine.
What is Nasodine Nasal Spray?
“Nasodine is a breakthrough treatment for the common cold, featuring a 0.5% concentration of povidone-iodine (PVP-I),” Molloy says.
“This broad-spectrum topical agent, also found in the Betadine brand of products, kills all viruses, and is now available for the first time in a nasal spray.
“Nasodine directly targets the viral source of colds, killing all respiratory viruses including rhinoviruses, which account for 50% of colds, coronaviruses accounting for 25%, along with influenza, RSV, and others.
“Significantly, this treatment carries no potential for viral resistance.
“Once approved for over-the-counter use, it will stand as a safe, accessible, and unique remedy for addressing the common cold.”
Explain how Nasodine works in terms of being a broad-spectrum nasal spray?
“In treating respiratory viral illnesses, such as the common cold, the challenge has always been that the infection of the nasal passages can be caused by any of 200 or more viruses from at least six major groups,” Molloy says.
“The problem is that we rarely know the infectious culprit and some microorganisms can mutate to evade targeted approaches, such as vaccines.
“By using a well-established broad-spectrum antimicrobial agent, ‘povidone-iodine’, in a safe and stable nasal spray format, it is possible to target the cause of the viral infection where it starts, in the nose.
“Nasodine has been shown to rapidly inactivate the myriad of viruses that can cause colds, and yet has been shown to be safe for nasal use.
“What’s more, because of its on-selective mode of action, it is virtually impossible for viruses to develop resistance to it.”
How is Nasodine different from other cold and flu products on the market?
“Nasodine targets the cause of the cold, the viral infection, rather than acting to suppress symptoms.
“Nasodine would be a world first medicine that actually targets the viral cause of colds.
“Through repeated application Nasodine is expected to suppress the viral load in the nasal passages, which was shown in the Phase 2 Covid trial, interrupt the infection cycle so stopping the spread of the infection, reduce symptoms and severity of the cold.”
What is the potential of Nasodine and why does a common cold treatment matter?
“The common cold is not a trivial disease with colds inflicting a staggering 17 billion cases across the globe annually,” Molloy says.
“In terms of DALYs (Disability-Adjusted Life Years), the collective burden of the common cold surpasses that of AIDS, Alzheimer’s, and influenza/RSV combined.
“Colds can also prove serious for vulnerable populations such as the elderly, asthmatics, individuals with compromised immune systems, and those with cystic fibrosis.
“Colds carry the inherent risk of exacerbating underlying health conditions and potentially leading to severe outcomes like pneumonia, necessitating hospitalisation or even resulting in death.
“Beyond the health implications, the societal ramifications are significant.
“Within Australia alone, each year there are 65 million colds, $4 billion drained from productivity, attributed to 14 million workdays lost and an equivalent number of school days compromised, an additional burden of six million surplus GP visits
and two million unnecessary antibiotic scripts that contribute to the issue of drug resistance.”
How significant was the Nasodine Phase 3 common cold trial?
“The trial was one of the largest Phase 3 trials of a prospective common cold treatment that has been completed anywhere in the world in the last decade,” Molloy says.
“Firebrick successfully enrolled 500 subjects into the trial with more than 50% of these subjects tested PCR-positive for a cold virus.
“Importantly, to our knowledge, it is the first large-scale Phase 3 trial of a broad-spectrum therapy that directly inactivates (kills) the more than 200 different viruses responsible for the common cold.
“The Phase 3 trial is intended to support registration of Nasodine in Europe and international partnering of Nasodine.”
Explain the results of the Phase 2 Covid trial – what do they mean and how does this relate to the common cold?
“The results showed that Nasodine treatment over three days in Covid-19 patients resulted in 100% reduction in viral load by the fourth day meaning all Nasodine subjects were 100% clear of live virus from both their nose and throat after completion of treatment,” Molloy says.
“These results prove that what we see in the laboratory in terms of antiviral activity of Nasodine translates to a clinical effect.
“It is important to appreciate that we were assessing viral load, not just in the nose, but also the throat, which is important because the nose (sneezing, blowing) and throat (coughing, talking) are responsible for almost 100% of viral transmission for the common cold and other respiratory viral infections.”
What does the results of the Phase 2 Covid trial mean in terms of Nasodine’s potential role in a future pandemic?
“In light of the fact that Covid-19 is unlikely to be the final global pandemic, the significance of a broad-spectrum nasal spray capable of swiftly eradicating pandemic viruses from the upper respiratory tract encompassing the nose and throat cannot be overstated,” Molloy says.
Nasodine could be extremely valuable to protect healthcare workers and the global population when faced with the next pandemic virus.
“Upon securing approval for common cold treatment, Australia will stand as the sole producer of the world’s first and sole approved nasal spray, which effectively kills a broad spectrum of pandemic viruses.”
“Further, Nasodine carries no risk of generating resistant mutant variants and poses no significant safety concerns.”
Describe the size of the global market for common cold treatments, and how does Firebrick see Nasodine fitting into this space?
“The global OTC (over the counter) pharmaceutical market is currently valued at more than US$170 billion and expected to grow 72% by 2030,” Molloy says.
“Nasodine has the potential to be a blockbuster OTC product.”
If Nasodine is approved by the TGA, how long will it take Firebrick Pharma to ramp up production?
“Through our Australian manufacturing partner, Probiotec, we are ready to start production, subject to scheduling and approval of packaging by TGA,” Molloy says.
“Nasodine could be on pharmacy shelves as early as 2024.”
Find out more.
