SaNOtize, the company behind an antiviral nasal spray for use against COVID-19, has begun selling its product in Israel and Bahrain, officially rolling out the Enovid, the company’s Nitric Oxide Nasal Spray (NONS). According to Dr. Gilly Regev, the Israeli-Canadian scientist who co-founded SaNotize, the company is also finalizing an agreement to sell the product in India in partnership with a local pharmaceutical company.
Enovid will go on sale at Israeli pharmacies for NIS 139 ($42), a price point she says the company is looking to bring down.
Dr. Regev tells NoCamels during a phone interview that the spray solution has proved effective against SARS-CoV-2, the virus that causes COVID-19, and its variants Alpha, Beta, Gamma, in lab tests conducted at Utah State University’s Antiviral Research Institute. The center is finalizing its testing against the Delta variant (first detected in India last year and also known as B.1.617.2), and Dr. Regev says she expects the same results.
“Our solution can kill the virus within 2 minutes,” she says, explaining that during lab tests, the spray stopped the coronavirus in its tracks within that time frame.
The spray is especially effective at suppressing viruses, she tells NoCamels, including influenza, rhinovirus, and others.
The Vancouver-based SaNOtize developed Enovid as a patented platform technology that allows for the topical delivery of nitric oxide. A naturally occurring nanomolecule with the formula NO (hence the name), it has proven anti-microbial properties that have been used to treat a variety of bacterial, fungal, and viral diseases.
The spray releases a small dose of nitric oxide and is designed to kill viruses in the upper airways. This prevents them from incubating and spreading to the lungs by providing a physical and chemical barrier.
Earlier this year, Enovid was granted an emergency use authorization as a medical device by Israel’s Ministry of Health and began a local production line. It has been approved for people 12 years of age and older.
“We are thrilled to have Enovid available in pharmacies in Israel and we are moving as quickly and diligently as possible through regulatory approval processes elsewhere in the world to make NONS available to the wider public,” said Dr. Chris Miller, SaNOtize co-founder and chief science officer, in a statement. “NONS was shown to reduce viral load, which decreases a person’s viral transmission, regardless of variant.”
The company completed a Phase II trial in Canada for COVID-19 and its variants and recently received approval from Health Canada to proceed with the enrollment of volunteers for Phase III trials. The approval for Phase III was granted for both prevention and early treatment separately, and SaNOtize plans to start with the prevention trial first.
The Health Canada approval follows results of a successful Phase IIb clinical trial in the UK by SaNOtize, Ashford and St Peter’s Hospitals NHS Foundation Trust in Surrey, and Berkshire and Surrey Pathology Services. The findings showed that SaNOtize’s Nitric Oxide Nasal Spray (NONS) was 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 randomized, double-blind, placebo-controlled Phase II trial evaluated 79 confirmed cases of COVID-19, and showed that early treatment for COVID-19 with SaNOtize “succeeded in significantly reducing the level of SARS-CoV-2, including in patients with high viral loads,” the company said in March.
The study concluded that NONS accelerated clearance of SARS-CoV-2 by a factor of 16-fold versus the placebo. There were also no adverse health events recorded in the UK trial, or in over 7,000 self-administered treatments given in the Canadian clinical trials, SaNOtize indicated.
The results of the UK study are set to be published by the Journal of Infection, a monthly peer-reviewed medical journal in the field of infectious disease, covering microbiology, epidemiology, and clinical practice.
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Dr. Regev tells NoCamels that SaNOtize’s solution “is based on strong scientific data” and that it’s “the only nasal spray company that has pursued clinical trials. This is what differentiates us from the rest.”
She indicates that the company is moving ahead with trial sites across the world to collect data on an even wider scale. The next trial will likely test how effective the solution is for helping to reduce symptoms.
In Israel, the company is in talks with the Ministry of Health to see if it will allow for the solution to be given to people who’d been exposed to a confirmed patient, she tells NoCamels.
Separately, SaNOtize also announced the appointments of Dan Suesskind, formerly the chief financial officer at Teva Pharmaceutical Industries, and Elaine Campbell, former president of AstraZeneca Canada, to its Board of Directors.
“As SaNOtize begins the next phase in its evolution, we are fortunate to welcome such experienced and respected leaders in the global pharmaceutical industry to our board,” said Dr. Regev in the statement. “Their expertise in expanding multinational pharmaceutical organizations will be invaluable.”
SaNOtize also indicated that it was in the process of regulatory submissions in several other countries including India, Brazil, and Mexico — states with some of the worst COVID-19 death rates.
“This will be affordable and can be used for prevention, to protect from any respiratory viral infection,” Dr. Regev told the Times of Israel in March, adding that the spray could help save lives in countries where access to the coronavirus vaccines is limited.
Currently, scientists and researchers across the globe are closely watching surges of infections with the COVID-19 Delta variant, a more easily transmitted strain caused by mutations on the spike protein. It is the dominant strain in the US, the UK, and Israel, where restrictions such as mask-wearing indoors and distancing were reimposed in recent weeks as the country monitors the upward trend of infections (even as severe cases remain relatively low).
The Israeli Ministry of Health announced last week that the Delta variant was found to be more resistant to the vaccine. According to a recent analysis by the ministry, the Pfizer vaccine was considered 64 percent effective at preventing symptomatic and asymptomatic disease and also 93 percent effective at preventing hospitalization after infection, and death.
SaNOtize also 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 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.