“Market is going to be surprised” as Firebrick Pharma set to launch antiviral nasal spray, Nasodine
Health & Biotech
Health & Biotech
Viral and infectious diseases have become a big focus of research for biotechs since the pandemic began.
A recent research by Future Market Insights unveiled an incredible projection for the global antiviral drugs market, indicating an anticipated value surpassing US$ 90 billion by 2033.
This remarkable surge reflects the heightened demand for innovative antiviral medications to prevent the next pandemic.
On the ASX, there’s a handful of biotechs focusing on antiviral drugs.
Starpharma (ASX:SPL), for example, is lurching full steam ahead on its antiviral barrier nasal spray, Viraleze.
Viraleze works by creating a barrier within the nasal cavity to physically trap and block cold/respiratory viruses. The spray forms a physical moisture barrier between viruses and the nasal mucous membrane that traps and blocks viruses.
Another antiviral biotech, Firebricks Pharma (ASX:FRE) is also about to launch its antiviral product, the Nasodene Nasal Spray, to the market.
Last week, shares of Firebrick climbed by as much as 100% after the company announced that Nasodine could be legally marketed in several countries as a nasal antiseptic/disinfectant without further clinical studies.
For commercial reasons, the company says it cannot disclose which countries, but sales are expected to commence in 2024.
Firebrick’s executive chairman, Peter Molloy, told Stockhead that it’s clear from recent studies on Covid-19 that Nasodene is effective at eliminating viruses from the nasal passages, and delivered 100% clearance of SARS Cov-2.
“That’s a very dramatic and positive proof of its efficacy as a nasal disinfectant to eliminate an important pandemic virus,” said Molloy.
“That alone is is proof enough that this is a product that should be used by healthcare workers and even consumers to protect themselves, and to reduce the risk of transmission, not just of Covid-19, but other viruses as well.”
Molloy said the goal for the company now is to find a way to make Nasodine available so that people can use it instead of having to deal with very high regulatory hurdles on an indication such as the common cold, which is very difficult to prove.
Firebrick had attempted to prove that Nasodene was also effective on common cold, but its most recent Phase 3 trial didn’t go quite as planned.
In September, the company announced that the Phase 3 trial failed to meet its primary endpoint, which was the impact of Nasodine on overall cold severity (GSS) in subjects with a confirmed viral infection (ITTi). Based on the reported results, the placebo (sterile water) performed better than Nasodine.
Following these findings, the company engaged a third party expert to validate the study. The expert concluded that there were inaccuracies in trial efficacy data, and that no efficacy conclusions can therefore be drawn.
The doomed 2023 trial followed a similar trial conducted in 2019, where Firebrick’s Phase 3 Trial on common cold failed to get approval from the Australian Therapeutic Goods Administration (TGA), despite results showing a positive therapeutic effect on patients.
“The TGA has been arguing against approving Nasodine on the basis of the results of the 2019 trial,” explained Molloy.
“Whereas we’ve been asserting continuously that the results of that 2019 trial are more than adequate to support an approval, especially given that the product is indisputably safe.
“However, TGA refused to approve it even though they acknowledged it was safe. So we’ve been fighting them through the Administrative Appeals Tribunal, and that remains ongoing.”
Firebrick says it remains committed to the development of Nasodine for the common cold, but will now consider alternative study designs that could avoid the problems experienced in the 2023 Trial. There are no immediate plans to repeat the 2023 Trial.
“We’re now looking for trial designs that don’t involve subjective patient reported outcomes, because that’s clearly part of the problem here, where you’re asking subjects to report subjectively on how they feel,” Molloy said.
Common cold aside, Molloy said the company’s next announcements will revolve around the launch of Nasodine as a nasal antiseptic/disinfectant in a specific country, although details are under wrap due to legal reasons.
“We have a unique nasal spray product that kills all viruses, and after Covid, it’s a no brainer that this product should be available in the market.
“And if it is available, people will use it. And I think the market is going to be surprised on the upside about the sales level that we can generate,” said Molloy.
Starpharma’s flagship is Viraleze, a nasal spray that contains an antimicrobial/anti-infective polylysine dendrimer called SPL7013.
Once applied, Viraleze forms a protective mucoadhesive barrier in the nose where most cold and respiratory viruses first take hold. SPL7013 in Viraleze then fortifies the barrier between the viral particles and the nasal cell membrane, effectively trapping viruses and blocking them from infecting the human cells.
Former Starpharma CEO, Dr Jackie Fairley, told Stockhead that antiviral measures such as Viraleze will remain important for as long as people continue to contract viral respiratory infections, whether it be a cold, seasonal flu, or a future pandemic virus.
“COVID-19 is not the first pandemic the world has faced, and it won’t be the last. Indeed, you could say that we are now between pandemics,” she said.
Biotron’s share price has more than tripled over the past year, at it embarks on the final stages of three Phase 2 clinical trials for HIV‐1, and COVID‐19.
In August, the company said the Phase 2 COVID-19 clinical trial of its antiviral drug BIT225 have completed dosing, marking the end of the clinical phase of the study.
Focus is now on the laboratory analyses of samples collected during the trial, with preliminary results expected soon.
The company is also conducting two HIV-1 Phase 2 trials, which were also recently completed at sites in Sydney and Thailand.
Results on the HIV-1 trials are also expected soon.
The antiviral drug specialist announced recently that a key patent relating to its lead drug candidate, ISLA-101, has been granted by IP Australia.
ISLA-101 is a drug with a well-established safety profile, being repurposed for the prevention and treatment of dengue fever and other mosquito (or vector) borne diseases.
Last week, the company was granted human research ethics approval to commence its ISLA-101 Single Ascending Dose study.
This study will be performed at Scientia Clinical Research’s trial facilities in Sydney, and supported by Beyond Drug Development as its clinical research partner.
Patient screening and dosing for this trial will commence immediately, with final read-out in early 2024.
PharmAust’s lead drug Monepantel (MPL) has been shown not only to be effective against cancer and neurodegenerative diseases, but also viral diseases.
According to research conducted by the Walter and Eliza Hall Institute of Medical Research in Melbourne in 2020, MPL can inhibit the progression of SARS-CoV-2.
The study used MPL and MPLS (monepantel sulfone) on human Calu-3 lung adenocarcinoma epithelial cells in culture, and showed virus particles of SARS-CoV-2 were suppressed by between 90% and 95%.
The views, information, or opinions expressed in the interview in this article are solely those of the interviewee and do not represent the views of Stockhead.
Stockhead has not provided, endorsed or otherwise assumed responsibility for any financial product advice contained in this article.