Toward the end of 2021 TrialSite reported to the world that a nasal spray exhibited the ability to kill 99.9% of the SARS-CoV-2 virus. 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. Developed by Vancouver-based SaNOtize Research and Development Corp, the product was helped along by testing done at the Utah State University Antiviral Research Institute. By the summer of 2021 the investigational product was evidencing positive results in Phase 2 clinical trials. By the end of 2021 various nations in the Middle East were embracing the drug from Bahrain to Israel. Now one of India’s largest generic drug producers, Glenmark Pharmaceuticals, embraced the nasal spray for distribution in the world’s second most populated nation. Just days ago, India’s regulatory, the Drug Controller General of India (DCGI) granted market authorization to Glenmark Pharmaceuticals– so now the product is authorized as a medical device targeting COVID-19 in India, Israel, Bahrain, Indonesia and Thailand. TrialSite has asked the question why not in the United States? Why is there so little news in the mainstream media? Are major pharmaceutical companies monopolizing the mindshare for vaccines and expensive branded therapies?
The Product
The SaNOtize Nitric Oxide Nasal Spray (NONS) product is designed to kill the SARS-CoV-2 virus in the upper airways, preventing it from incubating and spreading to the lungs. Based on nitric oxide (NO), a natural nanomolecule produced by the human body and proven with anti-microbial properties, evidence of a direct effect on SARS-CoV-2 2. The pharmacology, toxicity and safety data for no use of the nitric oxide has been well-established for decades, reports the product’s sponsor. They report that the nitric oxide molecule released from the NONs product is identical to the one delivered in its gaseous form to treat persistent pulmonary hypertension, or Blue Baby Syndrome in newborn babies, reports the company.
Positive Phase 3 Study Results
TrialSite has chronicled the development of this nasal spray product developed by Vancouver-based SaNOtize. Just recently the company reported a Phase 3 trial achieve its primary endpoint while demonstrating a reduction in SARS-CoV-2 log viral load in COVID-19 patients by over 94% within 24 hours of treatment. Within 48 hours the viral load was wiped out by 99%.
Moreover, a greater proportion of people in the high risk group, numbering 218, achieved a combination of clinical and virological cure, based on the WHO Progression Scale. They report a stunning medical time to virological cure at 4 days in the treatment group and eight days in the placebo group (p<0.05). Moreover, Glenmark Pharmaceuticals received manufacturing and marketing approval for the Nitric Oxide Nasal Spray (NONS) as part of an accelerated approval process.
Co-Founder and CEO Gilly Regev shared with TrialSite’s Founder Daniel O’Connor, “SaNOtize is excited to have Glenmark as our partner for manufacturing and distribution in India. We share the vision for this product and hoping it will become the first line of treatment and defence against respiratory viral infections.”
Accumulating Evidence Leads to Commercialization in India
The case for NONS becomes more compelling. From the early testing at Utah State University Antiviral Research Institute to successful Phase 2 study results in the UK—where Ashford and St. Peter’s Hospitals NHS Foundation Trust and Berkshire and Surrey Pathology Services produced a reduction of SARS-CoV-2 of 95% in 24 hours and 99% in 72 hours back in March 2021—with results published in the Journal of Infection in August 2021—to increased use even in pharmacies in the Middle East to the most recent clinical results, India now has an approved nasal spray for COVID-19.
Regulatory Approval in India against COVID-19
With no mention in Western news, India’s regulatory has made a major move in the war on COVID-19. Mumbai-based Glenmark Pharmaceuticals was granted manufacturing and marketing approval from the Drug Controller General of India (DCGI) for the Nitric Oxide nasal spray (NONS) as part of the accelerated approval process.
Glenmark Pharmaceuticals and Canada-based SaNOtize Research teamed up to commercialize the spay in India. Now called FabiSpray® this is the first easy to administer nasal spray treatment to treat COVID-19 anywhere worldwide. Their commercialization partnership dates to August 2021.
As part of this commercialization the approval is for the treatment of adult patients with COVID-19 who have a risk of progression of the disease, which includes either persons over the age of 45, non-vaccinated people and/or those with comorbidities.
Now Glenmark Pharmaceuticals will distribute the product to the following countries as an COVID-19 treatment:
Malaysia
Hong Kong
Singapore
Taiwan
Nepal
Brunei
Cambodia
Laos
Myanmar
Sri Lanka
Timor-Leste
Vietnam
What about Current use?
As TrialSite reported in November, 2021 the product was already in use in pharmacies as it’s received market authorization as a Class I Medical Device in the European Union. The product is approved in Israel, Thailand, Indonesia and Bahrain and sold under the brand name enovid™or VirX. ™
SaNOtize Research
A Vancouver, British Columbia based concern, SaNOtize Research & Development Corp. commercializes the multi-faceted antimicrobial properties of a liquid producing nitric oxide. The company developed the NORS™ product to treat and prevent upper respiratory and topical infections.
Founded in 2017 by Gilly Regev, PhD and Chris Miller, PhD, BA, RT, the company has made significant progress on minimal cash reserves. According to Crunchbase they have raised just a couple million dollars. Funding has come from a $1.2 million U.S. Department of Defense grant for a Phase 1 clinical trial, $1 million for Crowdfund in Israel and another $400,000 grant.
They currently employ between 10 and 20. Given the approvals and commercialization of NONS the company’s valuation is undoubtedly growing. Founders Regev and Miller are commendable for their results.