Interesting Covid news
Nasal Spray Stops COVID-19 In Use in Israel & Bahrain—Why Isn’t this Reported in America
TrialSite Staff November 28, 2021
At the start of 2021 TrialSite reported on UK-based NHS hospitals involved with a clinical trial involving a nasal spray that in a lab environment exhibited the ability to kill 99.9% of SARS-Cov-2, the virus behind COVID-19. Called the SaNOTize Nitric Oxide Nasal Spray (NONS), this investigational product was designed to kill COVID-19 in the upper airways, in effect inhibiting the virus from incubating and thereby making its way to the host’s lungs. The product was developed by Vancouver, Canada-based SaNOtize Research and Development Corp, based on results from lab tests at Utah State University’s Antiviral Research Institute. By the summer of 2021 the product was evidencing positive results in Phase 2 clinical trials. The investigational product was so promising that some countries, including Israel have allowed the product into pharmacies. What is the status of this important, promising investigational product in major markets? Why hasn’t the mainstream news in places like the United States or Europe more broadly covered this important easy to administer and cost effective investigational therapy? Are major pharmaceutical companies monopolizing mindshare for their vaccines and expensive branded therapies?
The Investigational Product
Available as a simple nasal spray, it 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 nano-molecule with proven anti-microbial properties, and which has a direct effect on SARS-CoV-2, the virus that causes COVID-19.
NONS is one of the few novel therapeutic treatments, outside of expensive monoclonal antibodies, that is proven to reduce SARS-CoV-2 viral load in humans.NONS has already received a CE mark in Europe, which is the equivalent of marketing authorization as a Medical Device (the CE mark confirms that the medical device meets certain “essential requirements” of the European General Medical Devices Directive and is safe for the intended purpose). By virtue of the CE mark, SaNOtize has permission to launch NONS in the EU. NONS has also been approved and is being sold in Israel and Bahrain under the trade name Enovid.
Positive Clinical Trial Results
A few months ago the company, SaNOtize Research Institute announced
a deal inked with Indian generic drug maker Glenmark Pharmaceuticals. In the deal the company and Glenmark announced an exclusive long-term strategic partnership to produce, market and distribute NONS for COVID-19 treatment in India and other Asian markets including Singapore, Malaysia, Hong Kong, Taiwan, Nepal, Brunei, Cambodia, Laos, Myanmar, Sri Lanka, Timor-Leste and Vietnam.
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Most Recent Clinical Trials
The company reported that back in March, 2021 NONs was reported safe and effective as an antiviral treatment to prevent transmission of COVID-19, shortening its course and reducing the severity of symptoms. In the first 24 hours, NONS reduced the average viral load by approximately 95%, and then by over 99% within 72 hours. This experimental product was evaluated in healthy volunteers and patients as part of UK and Canada-based clinical trials.
Their Phase 2 clinical trial (NCT04337918
) targeting 143 participants was completed early in the year. This multi-center, randomized, controlled Phase 2 clinical efficacy study involved their Nitric Oxide Releasing Solution treatment targeting COVID-19.
Available for Real World Use in Israel Pharmacies
In a little reported news release the company in July, 2021 reported
that the NONS product was made available in Israeli pharmacies. This news was available in multiple media
Based on Phase 2 results at the time, the product known as Enovid was granted an emergency use authorization as a medical device by Israel’s Ministry of Health earlier I the year. Called Enovid in Israel, the product provides a physical and chemical barrier to protect from viruses. Based on NONS, Enovid releases a small dose of nitric oxide (NO), a natural nanomolecule with proven anti-microbial properties including against SARS-CoV-2.
Dr. Chris Miller, Co-founder and Chief Science Officer of SaNOtize declared “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.” Also back in July SaNOtize announced the appointment of Dan Suesskind and Elaine Campbell to its Board of Directors. Noteworthy, Suesskind served as the Chief Financial Officer at Teva Pharmaceuticals Industries Ltd, the world’s largest generic drug maker from 1977 to 2008.
Expansion of Clinical Trial in Canada
Back in June of 2021 Health Canada authorized the company to commence with enrollment of volunteers in Phase 3 clinical trials and that it submitted an application for a New Drug Submission under Health Canada’s Interim Order.
Moreover the company reported over the summer it was concurrently in the process of regulatory filings in numerous other nations including Brazil and Mexico following the results of a successful Phase 2b clinical trial.
Led by principal investigator Dr. Jeremy Road, a private general provider, the study included BC Diabetes, LMC Manna, Diex Recherche Quebec as well as in Joliette and Sherbrooke.
Founded in 2017 by Dr. Gilly Regev, PhD, and Dr. Chris Miller, PhD, BA, RT, TrialSite has tracked this company with considerable interest. With $.25 million dollars raised—including some grant early on from the U.S. Department of Defense, SaNOtize develops and patents a Nitric Oxide Releasing Solution platform to treatment and prevent microbial infections, including drug resistant microbes.
The company targets a number of indications including COVID-19.
Call to Acton
will continue to monitor the progress of this product as well as seek an interview with the company’s principals.