Glenmark and SaNOtize publishes their Phase 3 Clinical Trials result on novel nasal spray for COVID-19

14 Jul 2022 , 12:44 PM

Glenmark Pharmaceuticals Limited and SaNOtize Research and Development Corp 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.

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 was reduced by 93.7% within 24 hours and by 99% within 48 hours of treatment with NONS. 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. Key secondary endpoints including clinical improvement assessed by WHO Clinical Progression Scale Score and extent/rapidity of virologic recovery was demonstrated in patients using NONS. The median time to virological cure was three days in the NONS group and seven days in the placebo group after start of treatment (four days sooner).

The exploratory evaluation of the proportion of immediate contacts having a positive COVID-19 test or becoming symptomatic, remained nearly the same in the NONS group while it numerically increased in the placebo group over the treatment.

“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 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.”

At around 12:44 PM, Glenmark Pharmaceuticals was trading at Rs385.40 per share down by Rs0.4 or 0.1% from its previous closing of Rs385.80 per share on the BSE.