A self-administered nitric oxide nasal spray (NONS) made by Vancouver-based biotech firm SaNOtize has been found to dramatically reduce Covid-19 viral load in infected patients after completing early-stage clinical trials in Canada and, most recently, the UK.
SaNOtize, alongside Ashford and St Peter’s Hospitals NHS Foundation Trust and Berkshire and Surrey Pathology Services in the UK, have announced results of Phase II trials indicating that SaNOtize’s nasal spray represents a safe and powerful antiviral treatment that could prevent the transmission of Covid-19, shorten its duration, and reduce the severity of symptoms in those already infected.
In a randomised, double-blind, placebo-controlled Phase II trial that evaluated 79 confirmed cases of Covid-19, SaNOtize’s early treatment significantly decreased the level of SARS-CoV-2, including in patients with high viral loads infected by the concerning UK variant of Covid-19.
Patients treated with SaNOtize’s spray saw an average viral log reduction of 1.362 in the first 24 hours, which corresponds to a decline of around 95%. Within 72 hours the viral load plummeted by more than 99%. No adverse events were recorded in the UK trial nor in earlier Canadian trials that saw over 7,000 patients testing the self-administered treatment.
“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.”
To date, NONS is the only novel therapeutic treatment outside of expensive monoclonal antibodies that has been proven to reduce SARS-CoV-2 viral load in humans, SaNOtize said.
The SaNOtize treatment kills the virus in the upper airways, preventing it from incubating and making its way to the lungs.
The therapy’s active ingredient is nitric oxide (NO), a natural nanomolecule produced by the human body with proven anti-microbial properties shown to have a direct effect on the –replication of SARS-CoV-2.
Based on the trial results, SaNOtize is planning to submit emergency use applications to regulatory authorities in the UK and Canada for the treatment and prevention of Covid-19.
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 company said swift approval and accelerated manufacturing could expedite an almost immediate safe return to normal work, school and social life, and accelerate economic recovery when compared to relying on vaccines alone.
“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.
“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.”