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SaNOtize moves to carve a new market demand: over-the-counter prevention

By Udi Damari on Sep 22, 2022 0 Comment

There are currently zero authorized or approved preventative COVID therapies in the U.S. but Canadian biotech SaNOtize wants to change that, charting plans to move a nasal spray into a phase 3 study as soon as October. 

It’s a deviation for the company that until now has been developing the nitric oxide nasal spray (NONS) as an early antiviral treatment, primarily assessing a reduction in viral load and testing time. But the takeaway from the company’s July 18 meeting with regulators was that those two markers wouldn’t be sufficient primary endpoints in a phase 3 treatment trial over a reduction in hospitalization or deaths. The problem—as has been exhibited by other potential COVID treatments—is that those latter data are difficult to accrue as much of the population has either vaccine-induced or natural immunity to the virus. 

As a result, the company is pivoting, exploring the use of the spray as a preventative treatment, which, if successful, would be pursued as a direct over-the-counter med. 

“There is no monograph right now for OTC antivirals—it doesn’t exist,” SaNOtize CEO Gilly Regev, Ph.D., said in an interview. “So it's a little bit of paving your own path, like we always need to do with nitric oxide. So it doesn't scare us.” 

Published by Max Bayer Jul 25, 2022 11:37am

https://www.fiercebiotech.com/biotech/sanotize-plans-phase-3-covid-prevention-trial-us-rather-treatment-regulators-ice-viral-load

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