Patients with a self-administered nasal spray application found to have reduced SARS-CoV-2 log viral load by more than 95% in infected participants within 24 hours of treatment, and by more than 99% in 72 hours
Trial concluded that treatment accelerated clearance of SARS-CoV-2 by a factor of 16-fold versus a placebo
Randomized, double-blind, placebo-controlled trial evaluated 79 confirmed cases of COVID-19, the majority heavily-infected with the UK variant
No adverse events were recorded in the group
Submission for Emergency Use in the UK and Canada for the treatment and prevention of COVID-19 is planned immediately
Biotech company SaNOtize Research & Development Corp., (SaNOtize), Ashford and St Peter’s Hospitals NHS Foundation Trust in Surrey, UK, and Berkshire and Surrey Pathology Services, UK, today announced results of clinical trials indicating 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.
In a randomized, double-blind, placebo-controlled Phase 2 trial that evaluated 79 confirmed cases of COVID-19, SaNOtize’s early treatment for COVID-19 significantly reduced the level of SARS-CoV-2, including in patients with high viral loads. 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 these 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.
"I expect this to be a major advance in the global battle against the devastating human impacts of the COVID-19 pandemic," said 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."
The SaNOtize treatment is designed to kill the virus in the upper airways, preventing it from incubating and spreading to the lungs. It 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 Seeking Emergency Use Authorization in UK and Canada
SaNOtize is applying to regulatory authorities in the UK and Canada for Emergency Use authorization. Swift approval and ramp-up of manufacturing could facilitate an almost immediate safe return to work, school and society, and spur an economic recovery that is months – if not years – ahead of full global vaccination.
Wide-scale equitable global availability of NONS could form a bridge during the global production and distribution of vaccines to help keep people safe and healthy. 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 results of the UK trial 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," said Dr. Gilly Regev, CEO and co-founder of SaNOtize. "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."
Double-Blind, Placebo-Controlled, Phase 2 Clinical Trial -- Details
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.
"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."
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.
"The rigour of this trial and the decades of safety data behind nitric oxide gives us full confidence in requesting emergency use approval in the UK, Canada and elsewhere in the world." said Rob Wilson, SaNOtize’s UK representative. "We are pleased to have conducted this crucial trial in the NHS and now hope that regulators will play their part in arming the public in the battle against this devastating disease."
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.
About Dr Stephen Winchester MSc MB BS FRCPath
Dr. Winchester is Consultant Medical Virologist at Frimley Health NHS Foundation Trust. Affiliated with Berkshire and Surrey Pathology Services (BSPS). BSPS is a joint contractual venture between Ashford and St Peter's Hospitals NHS Foundation Trust, Frimley Health NHS Foundation Trust, Royal Berkshire NHS Foundation Trust and Royal Surrey County Hospital NHS Foundation Trust.
About Robert Wilson
Robert Wilson is a former government Minister and Member of Parliament for the United Kingdom.
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