Vancouver-based company SaNOtize, co-founded by Israeli-Canadian scientist Dr. Gilly Regev, is launching its first clinical trial in the UK this week for a proposed antiviral nasal spray for use against COVID-19.
The tests will begin on Monday at Ashford and St Peter’s Hospitals NHS Foundation Trust in Surrey and will be overseen by Rob Wilson, a former British government minister who represents SaNOtize in the UK and EU, the company announced in a statement Sunday.
SaNOtize developed a patented platform technology that allows for the topical delivery of nitric oxide (a naturally occurring nanomolecule with the formula NO, hence the name) to treat a variety of bacterial, fungal, and viral diseases.
The company’s Nitric Oxide Nasal Spray (NONS) is designed to kill SARs-CoV-2, the virus that causes COVID-19, in the upper airways, preventing it from incubating and spreading to the lungs.
The solution is currently in Phase II prevention and efficacy trial in Canada, and early tests at Utah State University’s Antiviral Research Institute have shown that the nasal solution inactivated more than 99.9 percent of SARs-CoV-2, according to SaNOtize.
Separate animal studies with rodents performed at Colorado State University showed an average of over 95 percent reduction in SARS-CoV-2 viral load tested on the day following infection with half the rodents having no detectable virus at all. This was following inoculation with the virus and two treatments of SaNOtize’s nasal spray.
“The SaNOtize nasal spray provides a barrier,” said Dr. Chris Miller, chief science officer and co-founder of SaNOtize, in the company statement. “It contains nitric oxide which prevents and treats early infection by destroying the virus and impeding viral replication within the cells in the nose. In addition, nitric oxide has been shown to block the ACE-2 receptor essential for the virus to infect our cells. That is what makes our product unique and enables it to stand alone from any other nasal approach.”
Dr. Miller said the company envisions a potential regimen that will include cleansing the upper respiratory area with the spray at various points over the course of a day.
“In the morning when you get up, where the virus has shed and started collecting in the back of your upper airway, first spray of the day, and then you go out into the day, and you can’t always control social distancing as we end lockdown, and so we have nasal sprays throughout the day. At the end of the day, you come home and you basically rinse your nose and your nasopharynx, so that will clean your nose, your sinuses, and the back of your throat where these viruses initially reside,” he described.
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Wilson said that should the current Phase II results in Canada confirm the encouraging results obtained in the lab tests, “SaNOtize will be seeking emergency approval in Canada to proceed directly to Phase IV introduction of the product to the market as part of the continuing global fight against this deadly pandemic,” Wilson said in the statement.
The global vaccination program to combat COVID-19 is a key development, but it may “also take time to distribute to the general public,” he said, adding that meanwhile, mutant strains may develop that may require changes to the vaccine.
“It is not known how long the immunological protection will last. It is also unclear if the vaccines will prevent vaccinated people from becoming infected and potentially transmit the virus to other non-protected individuals. For these reasons, it is important to explore and deliver simple, safe and inexpensive therapeutic product solutions over the counter in the UK and EU as soon as possible,” Wilson said.
“The fact that a relatively easy and simple nasal spray could be an effective treatment is welcome news and offers a significant advance in our therapeutic armory against this devastating disease. Ashford and St Peters Hospitals NHS Foundation Trust is proud to be at the forefront of trialling this intervention,” said Pankaj Sharma MD PhD FRCP, professor of Neurology and Director of the Institute of Cardiovascular Research at Royal Holloway, University of London.
SaNOtize developed a number of nitric oxide-based therapies to treat a variety of bacterial, fungal, and viral diseases.
It was previously granted US and EU patents on its Nitric Oxide Releasing Solution (NORS) and is testing ready-to-use applications delivered through gargle solutions, nasal spray, and nasal lavage. Separate trials have shown that the solution was effective in lab conditions against viruses such as influenza A, hCoV-OC43 and H1N1 (swine flu), the company has said.
Dr. Regev, the Israeli co-founder of SaNOtize, told NoCamels last year that the company’s solutions are also undergoing two separate clinical trials, one for fighting nail fungi and a second for chronic sinusitis.
“Both conditions currently don’t have treatment,” she pointed out on the sidelines of the annual OurCrowd summit last February. OurCrowd is an investor in SaNOtize.