Firebrick Pharma (ASX:FRE) reports a patent covering the unique formulation of Nasodine Nasal Spray has been accepted in Australia.
The company says the patent (number 2021203846) is titled ‘Virucidal Formulations Containing Povidone-Iodine’ and once granted, expires in June 2041. The patent will be also filed in the United States, Europe and a number of other key markets.
The two pre-existing Nasodine patents, covering intranasal use of povidone-iodine (PVP-I) for the common cold and pandemic viral diseases respectively, are ‘methods-of-use’ patents, and the latest patent covers the pharmaceutical composition of the Nasodine formulation, regardless of intended use or site of application.
Firebrick Pharma Executive Chairman Peter Molloy said this is a very important development for Firebrick because it gives us our first composition patent for Nasodine.
“If ultimately granted in the US and Europe, this patent significantly extends the patent protection around Nasodine and should make it more valuable for partnering, in my view.”
Firebrick says the basis for the invention claimed in the patent is that the proprietary Nasodine formulation displays enhanced virucidal activity compared with PVP-I solutions alone, stating this is the case with human rhinovirus (HRV), which is the main cause of the common cold.
The patent discloses the results of in vitro studies of Nasodine against HRV-14 which is one of the more difficult rhinovirus strains for PVP-I to inactivate.
The company says the Nasodine formulation produced a 6-log reduction (99.9999%) in variable virus after 5 minutes exposure, compared with less than 2.5 log reduction with commercial PVP-I formulations, the latter based on published data.
According to the patent, the Nasodine formulation showed a ‘markedly’ increased virucidal activity compared to other PVP-I formulations (concentrations between 0.5% and 1%), at clinically-relevant exposure times of 2 and 5 minutes.
The patent also discloses that based on independent in vitro studies, the Nasodine formulation had enhanced antiviral activity against SARS-CoV-2 (COVID-19) when compared to aqueous PVP-I solution, and a range of formulations is covered in the accepted patent claims, notably including PVP-I concentrations between 0.10% and 1.25%.
Firebrick Pharma is a pharmaceutical company founded in 2012 to develop and commercialise a nasal spray treatment for the common cold based around the potential of povidone-iodine as a broad-spectrum antimicrobial agent, and the company owns numerous granted and pending patents including a core patent family that covers the use of intranasal povidone-iodine for the treatment and prevention of the common cold and a second patent family covering the prevention of pandemic diseases.
The company is currently completing 2 major clinical trials including a phase two trial of Nasodine in COVID-19 and a phase 3 trial for Nasodine to confirm its efficacy as a treatment for the common cold and support international approvals.