Nitric Oxide Nasal Spray Found Effective Against SARS-CoV-2
The clinical trial results indicate that SaNOtize’s Nitric Oxide Nasal Spray (NONS) represents a safe and effective antiviral treatment that could prevent the transmission of COVID-19 shorten its course, and reduce the severity of symptoms and damage in those already infected, was announced today.
Vancouver-based SaNOtize Research & Development Corp issued a press release stating a Phase 2 trial found early treatment with NONS for COVID-19 significantly reduced the level of SARS-CoV-2 coronavirus, including in patients with high viral loads.
The SaNOtize treatment is designed to kill the virus in the upper airways, preventing it from incubating and spreading to the lungs.
The company said the average viral log reduction in the first 24 hours was 1.362, which corresponds to a decline of about 95%.
Within 72 hours, the viral load dropped by more than 99%.
The majority of the study patients had been infected with the UK variant, which is considered a variant of concern.
There were no adverse health events recorded in the UK trial or in over 7,000 self-administered treatments given in earlier Canadian clinical trials.
NONS is the only novel therapeutic treatment so far proven to reduce viral load in humans that is not a monoclonal antibody treatment. Monoclonal antibodies are highly specific, expensive, and must be administered intravenously in a clinical setting, says the company.
“I expect this to be a major advance in the global battle against the devastating human impacts of the COVID-19 pandemic,” commented Dr. Stephen Winchester, Consultant Medical Virologist and Chief Investigator of this NHS Clinical Trial.
“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.”
NONS is based on nitric oxide (NO), a natural nanomolecule produced by the human body with proven anti-microbial properties shown to have a direct effect on SARS-CoV-2, the virus that causes COVID-19.
The pharmacology, toxicity, and safety data for NO use in humans has been well-established for decades. The NO molecule released from NONS is identical to the one delivered in its gaseous form to treat persistent pulmonary hypertension, or Blue Baby Syndrome, in newborn babies.
SaNOtize confirmed it is applying to regulatory authorities in the UK and Canada for Emergency Use authorization. The ease of NONS manufacture, storage, and use makes NONS a treatment candidate that could soon be widely available at low-cost for long-term care facilities, healthcare and frontline workers, and the general population.
In addition to providing antiviral treatment in the early stages of infection and for those who have yet to be vaccinated, NONS has also demonstrated that it could also reduce infectivity – the frequency of transmission from an infected person to a non-infected person.
The UK trial results corroborate the information gathered from SaNOtize’s earlier Phase 2 trials in Canada and independent lab tests at Utah State University’s Antiviral Research Institute.
“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,” stated Dr. Gilly Regev, CEO and co-founder of SaNOtize.
This study, conducted by Dr. Stephen Winchester and Dr. Isaac John at Ashford and St. Peter’s Hospitals NHS Foundation Trust, was devised to determine the clinical efficacy of NONS for the treatment of mild COVID-19 infection. The primary outcome measure was the difference in SARS-CoV-2 RNA load from baseline through Day 6 between NONS and control arms.
The study concluded that NONS accelerated clearance of SARS-CoV-2 by a factor of 16-fold versus the placebo, and it presents supporting evidence for the emergency use of NONS for prevention or treatment of patients with recent or established SARS-CoV-2 RNA infection during this COVID-19 pandemic.
“NONS destroys the virus, blocks entry into and halts viral replication within the nasal cavity, which rapidly reduces viral load. This is significant because viral load has been linked to infectivity and poor outcomes,” said Dr. Chris Miller, Chief Science Officer and co-founder of SaNOtize.
“There is currently a lack of an antiviral therapy that is effective against COVID-19 and its variants, can prevent or shorten the course of the disease, reduce damage, lower the severity of COVID-19, and can be made widely and readily available to the public. This is what makes NONS unique and enables it to stand alone from any other novel therapeutic application.”
SaNOtize Research & Development Corp. is a biotech company based in Vancouver, BC working to commercialize the multi-faceted antimicrobial properties of a liquid producing nitric oxide. The company has developed and patented a Nitric Oxide Releasing Solution platform technology (NORSTM) to treat and prevent microbial infections.
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