Home » Covid-19: SaNOtize seeks emergency approval for its nasal spray vaccine

Covid-19: SaNOtize seeks emergency approval for its nasal spray vaccine


Intranasal Covid-19 vaccines were developed by different pharmaceutical companies with the aim of reducing coronavirus transmissions better than shots do. But the question is simple, how does the intranasal covid-19 vaccine work and where does it currently stand in terms of trials and approvals?

Amongst the different companies to have created their own intranasal vaccine, SaNOtize is the first to have announced a successful trial on the 15th of March. The Biotech company SaNOtize Research and Development Corp, announced the results of the clinical trials which indicated that their Nitric Oxide Nasal Spray (NONS) represents a safe and effective antiviral treatment which could prevent the transmission of covid-19, shorten its course, and reduce the severity of the symptomes and the damage in patients already infected. 

According to BioSpace, the Phase 2 trial, which was conducted with Ashford and St Peter’s Hospitals NHS Foundation Trust in Surrey, evaluated 79 confirmed cases of covid-19. The early treatment for covid-19 significantly reduced the level of the coronavirus including patients with high viral loads. The trial further revealed that within 72 hours the viral load dropped by more than 99%. 

“I expect this to be a major advance in the global battle against the devastating human impacts of the COVID-19 pandemic,” said Dr. Stephen Winchester, Consultant Medical Virologist and Chief Investigator of this NHS Clinical Trial.

“This simple portable nasal spray could be highly effective in the treatment of COVID-19 and reducing onward transmission. Our trial included patients with a variant of concern and high viral loads yet still demonstrated significant reductions in the levels of SARS-CoV-2, which could be critical in supporting vaccines, preventing future outbreaks and safely reopening economies. Simply stated, I think this could be revolutionary.” he said. 

The SaNOtize treatment is designed to eliminate the virus in the upper airways, which prevents it from incubating and spreading to the lungs. Nitric Oxide is used, which is a natural nanomolecule produced by the human body with proven anti-microbial properties shown to have a direct effect on the covid-19 virus. The use of Nitric Oxide in humans has been well established for years by the pharmacology, toxicity and safety data.

Following this breakthrough with its trial, SaNOtize is also the first Biotech company to be applying to regulatory authorities in the UK and Canada for Emergency Use authorization.

“Now that NONS has been demonstrated to be safe and effective in clinical trials, we must move with urgency to get it into the hands of the public where it can help bring an end to the pandemic, accelerate a return to normality, and prevent future outbreaks of COVID-19 and its variants,” said Dr. Gilly Regev, CEO and co-founder of SaNOtize. 

“The human toll of this disease cannot be expressed simply in numbers, and each day compounds the frustration, fear and loss suffered by millions around the world. Combined with the roll-out of vaccines, NONS can help get the world back on its feet.” she said. 

Altimmune’s Intranasal Vaccine – AdCOVID

Altimmune, is a biopharmaceutical company, which has just started its phase 1 clinical trial for its intranasal vaccine called AdCOVID. AdCOVID is a single-dose intranasal vaccine candidate for COVID-19. It is designed to stimulate a broad immune response including both systemic immunity (neutralizing antibody) and local immunity (mucosal IgA, resident memory T cells) in the nasal cavity and respiratory tract. A data readout from this trial is anticipated in the second quarter of 2021. 

According to BioSpace, Altimmune also announced on the 15th of March that data obtained from its preclinical mouse model showed that a single intranasal dose of AdCOVID provided 100% protection against the coronavirus. 

The published preclinical studies have also demonstrated that the non-invasive intranasal administration makes it particularly well-suited for wide-spread vaccinations of large cohorts. Secondly, AdCOVID may offer the ability to control SARS-CoV-2 infection within the upper and lower respiratory tract. This has the advantages of potentially preventing infection at the site of virus entry, reducing the risk of significant respiratory disease and decreasing the likelihood of subsequent virus transmission in vaccinated individuals.

Atossa Therapeutics – AT-301 nasal spray

Atossa Therapeutics according to Clinical Trials Arena, reported that its clinical study of the AT-301 nasal spray had a  positive final result. The nasal spray is being developed to reduce covid-19 symptoms in patients that have already been diagnosed with the virus. 

The clinical study evaluated 32 healthy adults to assess the safety and tolerability of the nasal spray at two different dose levels. Final data showed that the AT-301 was safe and well tolerated in healthy participants of both genders except for one candidate which experienced adverse events which were considered moderate in severity. The AT-301 most common side effect observed from a single dose or multiple doses were nasal discomfort and sneezing. 

Steven Quay, President and CEO of Atossa said: “The results from this study are very encouraging and we look forward to quickly commencing the next study of AT-301.”

“We recently received input from the FDA on this programme and based in part on that input, we are now preparing to conduct an additional preclinical study, which we expect to start this quarter. Following that, we expect to apply to the FDA to commence a Phase II study here in the US.”