Clinical Data

 

Phase 2b early treatment trial was done in the UK, and NONS primary efficacy endpoint was achieved:

The results of this study were recently published in the peer-reviewed Journal of Infection (click here to read)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Double-blinded randomized early treatment for people tested Covid positive: 79 subjects (39 treatment, 40 placebo)

 

Regimen: self-administration of NONS 5-6x/day

 

Results:

Compared to the control group, there was a significant and rapid reduction in viral load in the treatment arm from day 1 through 6.

In addition, patients with a self-administered nasal spray application were found to have reduced Covid viral load by more than 95% in infected participants within 24 hours of treatment and by more than 99% within 72 hours.

 

The treatment group showed 16x higher viral reduction than the saline placebo arm on days 2 and 4, and 11x on day 6

47% of the treatment group felt better after four days of treatment vs. only 8% of the placebo group

 

Phase 2a prevention trial was done in Canada and showed high safety of NONS:

Double-blinded & randomized Covid prevention study, 143 subjects (103 treatment, 40 standards of care).

 

Regimen: self-administration of NONS up to 5x/day, nasal lavage, and gargle with NO liquid 1x/day

 

Results:

Zero infections in the prevention arm of the trial

Insufficient number of infections in placebo arm to show statistically significant effectiveness

No significant adverse events even though the dose administrated using nasal lavage and gargle was much higher than nasal spray alone

 

 

In Vitro study:

The company showed that NONS is highly efficient in vitro in immediately dropping the viral load of all tested Covid variants, including Delta, and other common viruses like influenza (H1N1).

 

 

Based on these results, SaNOtize says that this “invisible mask” is an excellent adjunct to vaccines, masks, hand sanitizer, and social distancing. The company believes that if Covid patients use NONS when the infection starts, the viral load will be much lower and, thus, symptoms will be lower.

 

The company reports it received approvals from Health Canada - no objection letter (NOL) - for two Phase 3 trials (prevention and early treatment), and it has started two Phase 3 treatment trials with their partners in India and Bahrain that will end by the end of 2021. The Canadian prevention trial has started. These trials will support full Health Canada Rx approval, followed by an Rx-to-OTC switch.

SaNOtize claims that its broad antiviral NONS can be a pivotal game-changer by providing an effective and convenient prophylactic solution that can be rapidly deployed with new viral strains and future pandemics. In addition to Covid, NONS can potentially prevent and treat other upper respiratory infectious diseases like influenza and the common cold. In countries which approved NONS as a medical device, the allowed claim is “to protect from viruses”.

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SARS-CoV-2,Prevention,Antiviral,Antimicrobial,COVID-19,Nitric oxide,Coronavirus,Treatment,Nasal, Covid Nasal Spray, Omicron, Delta, Variants