SaNOtize to seek emergency approval for its Covid-19-fighting nasal spray
The drugmaker has completed a Phase 2 clinical trial in the UK, Israeli CEO says treatment can help vaccines defeat the pandemic
Canadian healthtech company SaNOtize, led by Israeli co-founder and CEO Gilly Regev, is applying to regulatory authorities in the UK and Canada for Emergency Use authorization after announcing the results of clinical trials confirming that its nasal spray 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.
The company announced on Sunday that it had completed a Phase 2 trial that evaluated 79 confirmed cases of Covid-19, revealing that the spray succeeded in significantly reducing the level of SARS-CoV-2. Most of the patients had been infected with the UK variant. SaNotize conducted the trial with Ashford and St Peter’s Hospitals NHS Foundation Trust in Surrey, UK, and Berkshire and Surrey Pathology Services, UK.
The SaNOtize treatment is designed to kill the virus in the upper airways, preventing it from incubating and spreading to the lungs. The treatment contains nitric oxide, which is naturally produced by the body and contains strong anti-microbial properties that have an effect on the SARS-CoV-2 virus.
SaNOtize co-founder and CEO Gilly Regev. Photo: SaNOtize Corp.
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.
“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.”
“Now that SaNOtize’s Nitric Oxide Nasal Spray (NONS) has been demonstrated to be safe and effective, 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.”