Newly Published Phase 3 Study in People with COVID-19 Shows SaNOtize Nitric Oxide Nasal Spray Reduced Viral Load by 99% within Two Days

• Phase 3 trial demonstrated a reduction in SARS-CoV-2 viral load in high-risk COVID-19 patients by 94% and 99% within 24 and 48 hours of treatment, respectively
• Median time to a negative PCR test was three days after beginning treatment in the nitric oxide group vs. seven days in the placebo group (P < 0.05)
• Participants recruited during delta and omicron surges, suggesting antiviral properties of nitric oxide effective against evolving variants of concern

VANCOUVER, British Columbia & MUMBAI, India--(BUSINESS WIRE)-- SaNOtize Research & Development Corp., (“SaNOtize”), a Canadian anti-infective-focused therapeutics company, and Glenmark Pharmaceuticals Limited ("Glenmark”), a global, innovation-driven pharmaceutical company, today published results of a Phase 3 clinical trial in The Lancet Regional Health Southeast Asia, illustrating the effectiveness of nitric oxide nasal spray (NONS™) for the treatment of adult patients with COVID-19. Nitric oxide is a naturally occurring molecule known to have antimicrobial properties, including a direct effect on SARS-CoV-2, the virus that causes COVID-19, and its variants. The study is titled, “SARS-CoV-2 accelerated clearance using a novel nitric oxide nasal spray (NONS) treatment: A randomised trial.”

When beginning NONS treatment within three days of a positive COVID-19 test, viral load was reduced by approximately 94% within 24 hours of treatment and by 99% within 48 hours in participants at higher risk of disease progression, including older and unvaccinated patients. The study was carried out during the delta and omicron surges, suggesting that the treatment may be effective against variants of concern.

"The Phase 3 study results strongly support the safety and efficacy of NONS in the treatment of COVID-19 and its known variants,” said Gilly Regev, PhD, SaNOtize Co-Founder and CEO. “Nitric oxide blocks entry into cells of the nasal passage, kills the virus, and stops its replication, which is why viral load is reduced so rapidly with NONS. Viral load has been linked to infectivity, poorer health outcomes, and complications from long COVID. The evidence is mounting that NONS represents an effective, well tolerated antiviral treatment that significantly shortens the course of COVID-19.”

Study details

A randomized, double-blind, placebo-controlled study at 20 clinical sites across India evaluated 306 participants who had mild COVID-19 symptoms, confirmed with PCR test for SARS-CoV-2. Participants were enrolled in the study regardless of vaccination status (approximately 46% of participants were vaccinated).

Participants were randomly assigned to self-administer either two sprays of NONS per nostril six times a day over a seven-day treatment period or saline spray (active placebo) in the same administration schedule. All participants had access to standard supportive care. A subgroup of particular interest was participants (n=218) with a high risk of disease progression, including non-vaccinated participants or those at least 45 years of age and/or with co-morbidities.

Importantly, 58% of participants were enrolled during the second COVID-19 wave in India, in which the delta variant was predominant, and 42% during the third wave, in which the omicron and delta variants were predominant.

In the high-risk participants, NONS reduced the SARS-CoV-2 log viral load in COVID-19 patients by 93.7% within 24 hours of treatment and by 99% in 48 hours, compared baseline. At 48 hours of treatment, the reduction in viral RNA load was more than seven times greater in the NONS group compared to active placebo (P < 0.05). The average change from baseline in log viral RNA load through the entire length of treatment was statistically superior with NONS compared to placebo. Similar results were observed in vaccinated and unvaccinated populations. The median time to a negative a PCR test in the treatment group was three days vs. seven days after treatment initiation in the placebo group (P < 0.05).

Clinically, more patients receiving NONS (94%) were asymptomatic with no detectable SARS-CoV-2 RNA, based on the investigators’ WHO Clinical Progression Scale score improvement (two or more point reduction to a zero scale score), approximately one week after treatment compared to active placebo (81%; Day 16 treatment difference 12·6%, P < 0.05).

NONS was well tolerated, with no reports of moderate, severe, or serious adverse events. The most common side effect was nasal discomfort (reported by five participants in the NONS group and two in the placebo group).

The findings strongly mirror the reduction of viral load in an earlier Phase 2 trial (95% in 24 hours and 99% in 72 hours), conducted in the UK in March 2021 and published in the Journal of Infection.

“As we grapple with waning vaccine efficacy, mixed results from antiviral drugs and evolving variants of concern, there is an increasing need for effective and safe COVID-19 therapies,” said study author and SaNOtize Chief Scientific Officer and Co-Founder, Chris Miller, PhD. “To our knowledge, no other outpatient antiviral therapy has led to negative PCR conversion as quickly as NONS. The study data demonstrate the use of NONS to treat people with COVID-19 who are at risk for disease progression. The fact that NONS was effective, well tolerated, and rapidly reduced viral load suggests it may be a powerful weapon in the armamentarium required to manage COVID-19 and prevent future outbreaks.”

These data were submitted to India’s Central Drugs Standard Control Organization (CDSCO), which granted emergency use approval to NONS on February 9, 2022, for treatment of adult patients with COVID-19 who have a risk of progression of the disease. NONS is not yet approved for sale in Canada or USA. It is approved as a medical device under the brand name VirX^TM in Thailand and as a medical device under the brand name of enovid™ in Indonesia, Israel, and Bahrain. In Singapore, Nepal, and Hong Kong, it is registered as a Class I medical device and under CE mark in the European Union.

About SaNOtize

SaNOtize Research & Development Corp. is a pharmaceutical company based in Vancouver, BC, commercializing the multi-faceted antimicrobial properties of a liquid producing nitric oxide. The company has developed and patented a Nitric Oxide Releasing Solution platform technology (NORS^™) to treat and prevent upper respiratory and topical infections. For more information, visit www.SaNOtize.com. Follow us on social: LinkedIn, Twitter.

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