VANCOUVER, British Columbia– SaNOtize Research & Development Corp., (“SaNOtize”), a Canadian anti-infective-focused therapeutics company, today announced an oversubscribed $24 million Series B funding to advance its nitric oxide-based therapeutics pipeline. The lead treatment in the pipeline is the company’s nitric oxide nasal spray (NONS™), shown in clinical studies to treat and prevent COVID-19 infection, including a recent Phase 3 study published in The Lancet Regional Health Southeast Asia. The new funding round was co-led by Horizons Ventures and OurCrowd, with participation from ABC International, and enables SaNOtize to expand its research program, including its ongoing global Phase 3 NONS prevention clinical study with plans to recruit up to 3,000 participants in Canada and Sri Lanka.
“We are thrilled to embark on these new partnerships, as they empower SaNOtize to accelerate its research program in various therapeutic fields and expand our Phase 3 NONS COVID-19 trial to additional countries,” said Gilly Regev, PhD, SaNOtize Co-Founder and CEO. “Our clinical and observational studies found NONS to be safe and effective at both treating and preventing COVID-19, even amid delta and omicron surges. We look forward to expanding our clinical research and working toward regulatory approval in the United States and Canada.”
In SaNOtize’s clinical studies, NONS has been shown to rapidly reduce viral load in those with COVID-19 and decrease the risk of infection after known exposure. In a recent Phase 3 study, NONS shortened the time to negative PCR and demonstrated a reduction in SARS-CoV-2 viral burden in high-risk COVID-19 patients by 94% and 99% within 24 and 48 hours of treatment, respectively. Similar results were found in an earlier Phase 2 trial (95% reduction of viral RNA in 24 hours and 99% in 72 hours). As a preventive measure, those using NONS after a high-risk close contact exposure to COVID-19 were 75% less likely to become infected when compared to a control group, shown in an observational study.
“We are excited about SaNOtize’s Nitric Oxide Releasing Solution platform technology (NORS™️), bringing about highly affordable and effective treatment and prevention to a range of bothersome upper respiratory and topical infections, bettering health and wellness with an impactful option,” said Frances Kang, Portfolio Curator, Horizons Ventures, who was recently appointed to the SaNOtize board of directors.
SaNOtize was founded in 2017 by Dr. Regev and Chief Scientific Officer and Co-Founder, Chris Miller, PhD to leverage the antimicrobial properties of nitric oxide (NO), a naturally occurring molecule known to have antibacterial, antifungal, and antiviral properties. The company developed proprietary technology, NORS, to deliver NO at an effective dose across multiple therapeutic applications, including sprays, baths, lavages, gels, and creams. As demonstrated by other pharmaceutical companies, the nitric oxide gas molecule when inhaled is effective across multiple applications, including in newborns with pulmonary hypertension (blue baby syndrome). Research over the years continues to demonstrate a strong safety profile.
“We are delighted to participate in this important funding round for SaNOtize, whose breakthrough antiviral nasal spray continues to gain traction globally as the clinical results mount and NONS gains regulatory approval in more countries, as it is here in Israel,” said OurCrowd CEO Jon Medved. “Almost every week a colleague or collaborator in the field brings up the significant global unmet need and we acknowledge together the potential NONS has in protecting communities across the world from COVID-19.”
NONS is currently sold as a medical device under the brand name VirXTM in Thailand, Hong Kong, and Singapore and as a medical device under the brand name of enovid™ in Indonesia, Israel, and Bahrain. In India, NONS received an emergency use approval by the Central Drugs Standard Control Organization (CDSCO) for treatment of adult patients with COVID-19 who have a risk of progression of the disease. It is registered as a Class I medical device and under CE mark in the European Union. While NONS is not yet approved for sale in Canada or USA, SaNOtize is in discussions with regulatory authorities in both countries.
