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 byother 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.”