SaNOtize’s Nitric Oxide Nasal Spray (NONS) can minimize COVID-19 transmission and symptom severity
With the rising cases of COVID-19 globally and the constantly evolving variants of the SARS-COV-2 virus, an end to this pandemic seems to be uncertain. Amidst this uncertainty, a Vancouver-based biotech company 'SaNOtize Research & Development Corp. (SaNOtize)' has come up with a new ray of hope in the form of Nitric Oxide Nasal Spray (NONS), which could prevent SARS-CoV-2 transmission and shorten the COVID-19 course. It can also reduce the damage and severity of the COVID-19 symptoms in individuals already infected.
Nitric Oxide Role: Nitric oxide (NO), a natural nanomolecule, has been proved to be safe for use in humans . Previous studies have shown nitric oxide to have an antimicrobial effect on DNA, RNA viruses, and bacterial lung infections [2,3,4,5]. Similarly, nitric oxide has also shown the antiviral effect on the SARS-COV-2 virus .
SaNOtize's Nitric Oxide Nasal Spray (NONS): SaNOtize's patented NONS is an innovative approach that makes use of a formulation of Nitric Oxide Releasing Solution (NORS) to provide nitric oxide gas . Virucidal doses of nitric oxide are released by this solution for a sustained period and effectively inactivate Influenza A and SARS-CoV-2 viruses . This novel therapy has proved to be reducing the viral load with an added advantage over monoclonal antibodies in terms of ease of manufacture, storage, and self-administration in any non-clinical environment, as well as being comparatively inexpensive .
Why nasal spray? Airborne droplets of SARS-COV-2 virus on reaching nasal mucosa replicate locally in the mucosa's ciliated epithelial cells over an incubation period of 3 days . An inflammatory response similar to the common cold occurs due to the damaged mucosal cells. Simultaneously, the viral shedding occurs in the nasal secretions causing disease in the lower respiratory tract, potentially causing fatal viral pneumonia . The SaNOtize's NONS treatment kills and blocks the virus in the upper airways, thereby preventing it from incubating or reaching the lungs .
Efficacy Trials of NONS:
- A randomized, double-blinded, placebo-controlled Phase II trial was conducted on 79 confirmed COVID-19 cases, most of whom were infected by the UK variant of concern. This study showed significantly reduced viral load by early treatment even in patients with the high viral load and in patients infected by the variant of concern. Viral load reduction was around 95% (an average of 1.362 viral log reduction) in the first 24 hours, and more than 99% and within 72 hours.
- Significantly reduced SARS-COV-2 viral load was found in the infected patients after completion of early-stage clinical trials in Canada (study conducted on 7000 patients) and the UK with no adverse events recorded in either trial.
Conclusion: SaNOtize's NONS has proved to be a safe and effective antiviral treatment that may help prevent transmission of the virus and reduce the severity of symptoms in infected individuals. In times like these, wherein COVID-19 cases are on the rise due to the variants and vaccinating the entire population could be a time-consuming process, NONS could play a crucial role.
Comments by founders : "I expect this to be a major advance in the global battle against the devastating human impacts of the Covid-19 pandemic," said consultant medical virologist and chief investigator of the NHS trial Dr. Stephen Winchester. "This simple portable nasal spray could be highly effective in the treatment of Covid-19 and reducing onward transmission. Our trial included patients with a variant of concern and high viral loads yet still demonstrated significant reductions in the levels of SARS-CoV-2, which could be critical in supporting vaccines, preventing future outbreaks, and safely reopening economies. Simply stated, I think this could be revolutionary."
Based on these studies, SaNOtize is planning to submit emergency use applications to regulatory authorities in the UK and Canada to treat and prevent Covid-19. "Now that NONS has been demonstrated to be safe and effective in clinical trials, we must move with urgency to get it into the hands of the public where it can help bring an end to the pandemic, accelerate a return to normality, and prevent future outbreaks of Covid-19 and its variants," said SaNOtize CEO and co-founder Dr. Gilly Regev.
SaNOtize co-founder and chief scientific officer Dr. Chris Miller told Clinical Trials Arena: "Appropriate manufacturing facilities and materials are in place or in progress in the countries where we are seeking approval, so a ramp-up in manufacturing would be a matter of weeks, and major scale-up in a very few months, once approvals have been received. It would be premature to speculate on a precise timeline, however."
"We are in talks with various manufacturers and potential partners but can't comment on any talks with counter-parties that may be taking place. We are currently focused on the approval processes in the UK and Canada."
"The human toll of this disease cannot be expressed simply in numbers, and each day compounds the frustration, fear, and loss suffered by millions around the world. Combined with the roll-out of vaccines, NONS can help get the world back on its feet."
- Miller C, Miller M, McMullin B, et al. A phase I clinical study of inhaled nitric oxide in healthy adults. J Cyst Fibros. 2012;11(4):324-331. doi:10.1016/j.jcf.2012.01.003.
- Colasanti M, Persichini T, Venturini G, Ascenzi P. S-nitrosylation of viral proteins: molecular bases for antiviral effect of nitric oxide. IUBMB Life. 1999;48(1):25-31. doi:10.1080/713803459.
- Regev-Shoshani G, Vimalanathan S, McMullin B, Road J, Av-Gay Y, Miller C. Gaseous nitric oxide reduces influenza infectivity in vitro. Nitric Oxide. 2013;31:48-53. doi:10.1016/j.niox.2013.03.007.
- McMullin BB, Chittock DR, Roscoe DL, Garcha H, Wang L, Miller CC. The antimicrobial effect of nitric oxide on the bacteria that cause nosocomial pneumonia in mechanically ventilated patients in the intensive care unit. Respir Care. 2005;50(11):1451-1456.
- Miller CC, Hergott CA, Rohan M, Arsenault-Mehta K, Döring G, Mehta S. Inhaled nitric oxide decreases the bacterial load in a rat model of Pseudomonas aeruginosa pneumonia. J Cyst Fibros. 2013;12(6):817-820. doi:10.1016/j.jcf.2013.01.008.
- UK Clinical Trial Confirms SaNOtize's Breakthrough Treatment for COVID-19. Surrey, UK: SaNOtize Research & Development Corp; March 15, 2021. https://www.businesswire.com/news/home/20210315005197/en. Accessed March 16, 2021.
- ClinicalTrials.gov [Internet]: National Library of Medicine (US). Identifier NCT04337918, Nitric Oxide Releasing Solutions to Prevent and Treat Mild/Moderate COVID-19 Infection (NOCOVID); 2020 April 6; [about 2 screens]. Available from: https://clinicaltrials.gov/ct2/show/record/NCT04337918