VANCOUVER, British Columbia & MUMBAI, India– Canadian pharmaceutical company SaNOtize Research & Development Corp., (SaNOtize), and Glenmark Pharmaceuticals Limited (Glenmark), a global, innovation-driven pharmaceutical company, today announced successful results of Phase 3 clinical trials and approval from India’s drug regulator for the treatment of adult patients with COVID-19 who have a risk of progression of the disease.
The study confirmed that SaNOtize’s Nitric Oxide Nasal Spray (NONS) represents a safe and effective antiviral treatment that shortens the course of COVID-19, and could prevent the transmission of COVID-19.
In a randomized, double-blind, placebo-controlled, parallel-arm study at 20 clinical sites across India that evaluated 306 patients, NONS reduced the SARS-CoV-2 log viral load in COVID-19 patients by more than 94% within 24 hours of treatment, and by more than 99% in 48 hours as compared to saline control. Treatment also demonstrated, in the high-risk group (n=218), a statistically significant greater proportion of patients who achieved a combination of clinical and virological cure, based on the World Health Organization (WHO) Progression Scale. Moreover, the median time to negative PCR, in this group, was 4 days in the treatment group compared with 8 days in the control. Test subjects included patients infected with different variants, likely including Delta and Omicron. There were no significant adverse health events recorded in the Phase 3 trial, or in over 500 subjects treated so far with NONS in clinical trials.
The reduction in log viral load corroborates the reduction of viral load in the UK Phase 2 trials (a reduction of 95% in 24 hours and 99% in 72 hours), conducted in March 2021 by Ashford and St Peter’s Hospitals NHS Foundation Trust, and Berkshire and Surrey Pathology Services, and published in the Journal of Infection in August 2021.
“These results definitively substantiate the safety and efficacy of NONS in the fight against COVID-19,” said Dr. Gilly Regev, SaNOtize Co-Founder and CEO. “We are thrilled to be able to provide COVID patients with an affordable product that has been shown to deliver a faster cure. And with the proven safety profile of NONS, we look forward to this becoming the first line of treatment and potentially defense for COVID infection worldwide.”
The SaNOtize treatment is designed to kill the virus in the upper airways, preventing it from incubating and spreading to the lungs. It 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.
With the receipt of manufacturing and marketing approval from India’s drug regulator, SaNOtize’s strategic partner, Glenmark, will launch NONS commercially in India under the brand name FabiSpray®. The approval is for the treatment of adult patients with COVID-19 who have a risk of progression of the disease, which includes either persons over the age of 45, non-vaccinated people and/or those with comorbidities. Glenmark entered into an exclusive long-term strategic partnership with SaNOtize in August 2021 to manufacture, market and distribute NONS for COVID-19 treatment in India and other Asian markets including Singapore, Malaysia, Hong Kong, Taiwan, Nepal, Brunei, Cambodia, Laos, Myanmar, Sri Lanka, Timor-Leste and Vietnam.
NONS has a marketing authorization as a Class I Medical Device in the EU. NONS is also approved and being sold in Israel, Thailand, Indonesia and Bahrain, under the name enovid™ or VirX™.
“As viral load is an important determinant of disease severity and transmission of COVID-19 infection, demonstration of reduction in the viral load is expected to have significant clinical consequences from a patient and community perspective,” said Dr. Monika Tandon, Senior Vice President and Head – Clinical Development, Global Specialty/Branded Portfolio for Glenmark. “In the current scenario, with new emerging variants exhibiting high transmissibility, this novel product provides a useful option in the world’s fight against COVID-19.”
Glenmark will submit the clinical trial data for publication in a peer-reviewed journal in order to share its findings.
