Ashford and St. Peter’s Hospitals NHS Foundation Trust Commence Clinical Trial to Evaluate Nasal Spray that Stops COVID-19

Ashford and St. Peter's Hospitals NHS Foundation Trust Commence Clinical Trial to Evaluate Nasal Spray that Stops COVID-19

Ashford and St. Peter’s Hospitals NHS Foundation Trust, based in Surrey, UK, just stated a clinical trial involving a nasal spray that in a lab environment has exhibited the ability to kill 99.9% of the coronavirus, the virus behind COVID-19. Called the SaNOtize Nitric Oxide Nasal Spray (NONS), the investigational product is 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. Developed by Vancouver, Canada-based SaNOtize Research and Development Corp. (SaNOtize), the company is banking on independent lab tests at Utah State University’s Antiviral Research Institute that demonstrate amazing results. They shared that preclinical research using rodents infected with COVID-19 reveal an over 95% reduction in viral presence within the first day of infection. Classified as a device, this investigational product is also undergoing Phase 2 clinical trials throughout Canada and now the UK. This class of treatment would offer additional protection along with authorized vaccines. The worldwide R&D effort to overcome COVID-19 accelerates. Should SaNOtize’s product prove efficacious and sachieve even emergency use authorization, this privately held, Vanoucver-based venture’s valuation will certainly care for investors as well as patients. 

TrialSite offers a brief breakdown for those in the network interested in this investigational product.

What is the relevance of this investigational treatment?

The company (sponsor) notes in their recent press release that research published in Nature confirms that the nose represents the primary infection area for SARS-CoV-2, the virus behind COVID-19. The research finds that this is especially so during the early stages of infection. Presently, clinical trials conducted at hospitals are ongoing in the United States, Canada and Europe with seriously ill COVID-19 patients inhaling the gas to kill the virus in their lungs, with the possibility of preventing progression of severe infection.

Currently, there are a couple dozen studies ongoing, although some have been withdrawn.

What is the SaNOtize treatment?

Based on a nitric acid, a natural nanomolecule produced by the human body with proven anti-microbial properties demonstrated to have direct effect on SARS-CoV-2. This treatment can be delivered via spray, throat gargle or nasal lavage.

What’s the importance of nitric oxide?

Well its healing properties were first discovered by Prof. Ferid Murad of Stanford University, among others, for which he shared the Nobel Prize in medicine in 1998. As it turns out, Prof. Murad is on the board of SaNOtize.

On the topic, Dr. Murad was on the record, “Nitric oxide is an incredibly versatile molecule that regulates among everything in our body.” He continued, “When used therapeutically, it has a well-documented safety profile and is demonstrated to be effective against a wide variety of viruses, bacteria and fungi. I’m excited to be working with the SaNOtize team and believe they have a safe technology that could be effective in treating infections, including COVID-19.”

How would it protect people from COVID-19?

This productization of nitric oxide the sponsor hopes will act as a “barrier” to the pathogen. It possesses properties that can help prevent early infection as it kills SARS-CoV-2, hence hindering viral replication within the cell’s location in the human nose. Moreover, according to the founder of SaNOtize, Dr. Chris Miller nitric oxide can block the ACE-2 receptor which is an essential support for the virus. 

What do the Utah-based lab tests reveal?

Independent tests were conducted at Utah State University’s Antiviral Research Institute according to a press release by the sponsor company. The findings: the company’s Nitric Oxide Releasing Solution inactivated more than 99.9% of SARS-CoV-2, the virus behind COVID-19 within 2 minutes.

How about the preclinical animal research at Colorado State University?

At Colorado State University, preclinical researchers experimented on rodents intentionally infected with SARS-CoV-2. They found that when inoculating the rodents with the virus and two treatments of SaNOtize’s nasal spray that a reduction of over 95% in SARS-CoV-2 viral load resulted just a day after the treatment. Half of the rodents exhibited no detectable virus whatsoever.

Positive Results will Lead to Filing of EUA

A former British government minister, Rob Wilson, retained by the company for business development and lobbying activity in the UK and EU, suggests that Phase 2 Canadian trial results are positive they will pursue emergency approval in Canada and proceed directly to Phase 4.

What is the importance of such a treatment if it turns out to be safe and effective?

Although the vaccine program is of paramount importance, it’s not the entire story for beating COVID-19. Of course, there are some people that cannot take a vaccine for a variety of reasons. Other vulnerable populations will need additional protection. Exactly how long vaccines will actually work to provide immunological protection isn’t really known—it could be six months or even a year but maybe not for some people. Moreover, the vaccine won’t always work and it will take some time for pervasive inoculations in places such as Canada, America or Europe. 

Still not certain is whether those that are vaccinated will get reinfected. Thus, the importance of offering safe, effective and economical therapies to help combat COVID-19.

What are more details on the Canadian trial?

In one Canadian Phase 2 clinical trial (NCT04337918), the sponsor conducts a multi-center, randomized, controlled study evaluating the novel NORS treatment for the prevention and treatment of COVID-19 in healthcare workers at risk of infection. Targeting 143 participants, the study commenced in May and should wind up at the end of this month. The sponsor employed two CROs for this study, including Emmes and France-based Keyrus Life Science

Who is the sponsor?

SaNOtize Research and Development Corp (SaNOtize) is based in Vancouver, Canada, founded by Dr. Gilly Regev, PhD, and Dr. Chris Miller, PhD. A biotech company, they are working to commercialize the multifaceted antimicrobial properties of the liquid producing nitric oxide. They have developed and patented a Nitric Oxide Releasing Solution platform technology (NORS™) to treat microbial infections.

According to LinkedIn, the company has raised $2.5 million with one investor. Privately held, they were founded in 2017.

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