Common cold may have met its match with Firebrick Pharma nasal spray results looming

After success in dealing with Covid-19, Firebrick’s nasal spray is being touted as a potent weapon against the common cold. Trial results are imminent.

Firebrick Pharma is hopeful of a breakthrough in treating the common cold. (and yes, this does seem like an uncommonly robust reaction to a cold). Picture: Getty Images

Firebrick Pharma may be just a month from proving its nasal spray - which has already proven effective against Covid-19 - can reduce the duration and severity of the common cold and prevent its spread.

Firebrick (ASX:FRE) is eagerly awaiting results of its Phase 3 trial, which is due by the end of September.

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This comes after Nasodine nasal spray achieved its primary endpoint in a Phase 2 trial of its treatment of Covid-19.

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 had successfully completed recruitment, with 500 subjects enrolled.

Nasodine reduces 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 per cent reduction by day four, compared with 48 per cent for placebo.

The treatment regimen ran over two and a half days and by the fourth day, all of the Nasodine subjects were clear of the virus.

The trial, conducted in South Africa, recruited 39 subjects, 23 of whom were culture-positive and qualified for the primary endpoint population.

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Achieving statistically significant results in spite of the small number of subjects is what FRE had 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 past decade.

The trial could produce a holy grail that has eluded medical scientists for centuries, by reducing duration and severity of symptoms and helping to stop spread of viruses causing the illness.

FRE has recruited 500 subjects for the trial.

The primary endpoint is the impact of Nasodine versus placebo on over-all cold severity in enrolled subjects who tested PCR-positive for a respiratory virus (excluding SARSCoV-2), referred to as the ITTi population.

Based on progressive viral testing results, the ITTi population is projected to be at least 255 subjects (about 50 per cent of all subjects), which is 130 per cent 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 would support registration of Nasodine in Europe and international partnering of the spray.

The EU registration dossier is due be filed in January 2024 and FRE is confident the schedule will be met.

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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.

Company chairman 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 such as its sore throat gargle.

His observation that Betadine effectively treaed viral-induced sore throats sparked the idea of creating the world’s first common cold treatment by targeting nasal viral infections.

Firebrick Pharma co-founder and executive chairman Dr Peter Molloy. Picture: FRE

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 Molloy, to discuss Nasodine’s progress in treating Covid-19 and what a cure for the common cold would mean for medicine.

What is Nasodine Nasal Spray?

“Nasodine is a breakthrough treatment for the common cold, featuring a 0.5 per cent 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 per cent of colds, coronaviruses accounting for 25 per cent,  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 non-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 per cent of these subjects testing 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 per cent reduction in viral load by the fourth day, meaning all Nasodine subjects were 100 per cent 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 per cent 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 $US170 billion and expected to grow 72 per cent 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.”

This content first appeared on stockhead.com.au

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