The second phase of a clinical trial investigating a nasal spray made by Australian pharmaceutical company Firebrick Pharma (ASX: FRE) has commenced, with 210 COVID-positive adults to be recruited.
The company is looking into whether its spray called Nasodine can reduce the nasal shedding of SARS-CoV-2, with Firebrick building on its expertise in the development of nasal spray products for the treatment of the common cold.
It follows a 2021 pilot trial in South Africa, where researchers found a single Nasodine dose led to an overall 79 per cent reduction in viral shedding at one hour after the dose in six COVID-19 patients.
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.
While not the primary purpose of the Phase 2, Firebrick will also look at whether Nasodine treatment reduces the number of days to a negative rapid antigen test.
“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,” Firebrick executive chairman Dr Peter Molloy said.
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 to support international regulatory approvals.
“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 in nasal viral load in patients who are shedding the virus,” Molloy said.
“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.”
Firebrick is not the only ASX-listed company looking to tackle COVID-19 with a nasal spray; it has competition with Starpharma (ASX: SPL).
Starpharma distributes VIRALEZE - a broad-spectrum antiviral nasal spray which has been shown to have potent virucidal activity in multiple respiratory illnesses including SARS-CoV-2
The product creates a physical barrier that traps and blocks the virus, killing it before it can take hold in a person. This differs from Firebrick’s Nasodine which is a treatment, rather than a preventative tool.
While Starpharma initially saw significant investor support after announcing VIRALEZE’s antiviral potency, hitting highs of more than $2.30 in February 2021, regulatory hurdles in the UK meant the product was pulled from shelves in that market.
SPL shares dived in response, and are yet to pick back up even though the company announced it would relaunch VIRALEZE in the UK after resolving issues raised by the UK Medicines and Healthcare products Regulatory Agency (MHRA).
Price movement comparisons with Firebrick are difficult, considering the Melbourne-based company only listed on the ASX in February this year. Nevertheless, FRE is trading down 13.21 per cent from where it closed on debut of $0.53 per share, and is currently steady today at $0.46 per share.
Cannabis treatment trial for long-COVID enrols first patients
A clinical trial to assess the effectiveness of medicinal cannabis company Bod’s products on long-COVID has enrolled its first patients, with the study a “major step” in the commercialisation process for the Australian company.
Bod, in collaboration with independent scientific drug body Drug Sciences UK, will see whether its MediCabilis product can treat symptoms of long-COVID.
Long-COVID is an emerging condition referring to ongoing or new symptoms that develop in the eight weeks following an initial COVID-19 infection.
Symptoms include shortness of breath, fatigue, ongoing chest discomfort, loss of concentration, chronic pain, anxiety and insomnia. Many of these symptoms are “amenable to treatment with cannabis-based medicines” according to Bod.
30 participants over the age of 18 that are suffering from long-COVID will be enrolled in the trial. They will be administered MediCabilis on a daily basis over a six month period, and undertake self-reporting assessing common long-COVID symptoms through a dedicated smartphone application.
“First patient enrolment is a major milestone for Bod and highlights the commencement of this landmark study. We already have data that supports the use of MediCabilis for the alleviation of a number of long-COVID symptoms and look forward to building this out further so that our medicine can be used for another emerging need state,” Bod CEO Jo Patterson said.
“Long-COVID is a major market and this clinical trial will provide Bod with potential evidence for the use of its CBD- dominant medicinal cannabis product. This allows the Company to commercialise another product for a particular need state, as well as the opportunity to build further IP around our unique extract.
“Upon completion of the trial, we will continue to work with Drug Science to progress further research, potential licensing opportunities and the sale of MediCabilis as a defined medicine for use against long-COVID.”
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