Glenmark Pharmaceuticals Limited (Glenmark) and SaNOtize Research and Development Corp, on Wednesday announced that The Lancet Regional Health Southeast Asia (TLRHSEA) –peer reviewed, high impact journal published the successful phase 3 clinical trial results of SaNOtize’s Nitric Oxide Nasal Spray (NONS) study titled: “SARS-CoV-2 accelerated clearance using a novel nitric oxide nasal spray (NONS) treatment: A randomized trial.
“We are excited to publish the study of the novel Nitric Oxide Nasal Spray, which positively impacts the lives of people, in The Lancet group of journals. The robust double-blind trial demonstrated significant efficacy and remarkable safety of NONS. This therapy has the potential to make a crucial contribution to COVID-19 management, with its ease of use in the current highly transmissible phase of pandemic”, said Dr. Monika Tandon, Senior VP & Head – Clinical Development, Glenmark Pharmaceuticals Ltd in a statement.
The study demonstrated that patients who received NONS had significant reduction in viral load within 24 hours, which was sustained over seven days of treatment. Viral load wasreduced by 93.7% within 24 hours and by 99% within 48 hours of treatment with NONS, the company claimed. The average change from baseline in log viral RNA load through the entire treatment duration was statistically superior with NONS compared to placebo. Similar results were observed in vaccinated and unvaccinated populations. The study was conducted during the delta and omicron surges.
“The Phase 3 study results strongly support the safety and efficacy of NONS in the treatment of COVID-19 and its known variants. Nitric oxide blocks entry into 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 COVID19,” said Gilly Regev, PhD, SaNOtize Co-Founder and CEO.
The companies informed that the study was conducted by Glenmark in 306 vaccinated and non-vaccinated adults of symptomatic mild COVID-19 across 20 clinical sites in India. This randomised, double-blind phase 3 clinical trial evaluated a seven-day treatment of NONS plus standard of care versus placebo nasal spray plus standard care in patients with symptomatic COVID-19.
The study revealed that the NONS treatment was found to be well-tolerated, establishing an advantage of locally acting nasal therapy. None of the patients reported any moderate or severe adverse events, the company claimed.
In July last year, Glenmark entered into an exclusive long term strategic partnership with Canadian biotech firm SaNOtize, to manufacture, market and distribute its breakthrough Nitric Oxide Nasal Spray 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.
In February this year, Glenmark launched NONS under the brand name FabiSpray® after receiving manufacturing and marketing approval from the Drugs Controller General of India (DCGI) as part of the accelerated approval process.