New Drug Submission Application Commenced Under Health Canada Interim Order
SaNOtize Research and Development Corporation announced that it has received approval from Health Canada to proceed with enrollment of volunteers in Phase III trials following earlier positive Phase II results for its Nitric Oxide Nasal Spray (NONS) for the prevention and early treatment of COVID-19 and its variants. The Health Canada approval also follows results of a successful Phase IIb clinical trial by SaNOtize, Ashford and St Peter’s Hospitals NHS Foundation Trust in Surrey, UK, and Berkshire and Surrey Pathology Services, UK in March. The results of the UK study were submitted to, and accepted by, the Journal of Infection.
The approval for Phase III trials was granted for both prevention and early treatment separately; SaNOtize will begin enrolment for the prevention trial first.
“We are grateful for Health Canada’s fast response and we are moving as quickly as possible to start the trial and enrol volunteers for Phase III trial here in Canada and elsewhere in the world,” said Dr. Chris Miller, SaNOtize Co-founder and Chief Science Officer.
Concurrently, SaNOtize submitted an application for a New Drug Submission under Health Canada’s Interim Order, which allows for the earlier filing of applications and rolling submission of data for drugs that show promise to treat or prevent COVID-19.
“NONS reduces viral load, which decreases a person’s transmission of the SARS-CoV-2 virus, regardless of variant,” said Dr. Gilly Regev, SaNOtize Co-founder and CEO. “Recent third-party lab studies demonstrated NONS’ effectiveness across variants, including the Alpha and Gamma variants.”
The SaNOtize treatment is based on nitric oxide (NO), a natural nanomolecule produced by the human body with proven anti-microbial properties shown to have a direct effect on SARS-CoV-2, the virus that causes COVID-19. The pharmacology, toxicity, and safety data for NO use in humans has been well-established for decades. The NO molecule released from NONS is identical to the one delivered in its gaseous form to treat persistent pulmonary hypertension, or Blue Baby Syndrome, in newborn babies.
About SaNOtize SaNOtize Research & Development Corp. is a biotech company based in Vancouver, BC working to commercialize the multi-faceted antimicrobial properties of a liquid producing nitric oxide. The company has developed and patented a Nitric Oxide Releasing Solution platform technology (NORSTM) to treat and prevent microbial infections.