Glenmark Pharmaceuticals Limited (Glenmark), an innovation-driven, global pharmaceutical company, and SaNOtize Research and Development Corp, today 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.
According to the study, patients who received NONS saw a substantial drop in viral load after 24 hours, which persisted over the course of seven days of therapy. After receiving NONS therapy, viral load decreased by 93.7% in 24 hours and by 99.7% in 48 hours.
The average change in log viral RNA load from baseline throughout the course of the entire therapy was significantly better with NONS than with placebo. Both populations with and without vaccinations had comparable outcomes.
The investigation was carried out during the omicron and delta surges. The extent/speed of virologic recovery, as measured by the WHO Clinical Progression Scale Score, and other important secondary objectives were shown in patients utilising NONS. After therapy began, the median time to virological cure was three days in the NONS group and seven days in the placebo group (four days sooner).
While it rose quantitatively in the placebo group during the course of treatment, the exploratory examination of the proportion of immediate contacts who had a positive COVID-19 test or developed symptoms stayed practically constant in the NONS group.
“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.”
Study by Glenmark
The investigation was carried out by Glenmark in 306 persons with moderate COVID-19 symptoms who were both vaccinated and unvaccinated across 20 clinical locations in India. In patients with symptomatic COVID-19, this randomised, double-blind phase 3 clinical study compared a seven-day therapy of NONS plus standard care to a placebo nasal spray with standard care.
The effectiveness of this transformative NONS in high-risk patients (unvaccinated, or 45 years of age, or had one or more comorbidities) was evaluated after seven days of therapy using the key outcome measure of nasal SARS-CoV-2 RNA rapid clearance. It was also investigated to see if NONS might be used experimentally to prevent infection in these COVID-19 patients’ close contacts.
The benefit of locally acting nasal therapy was shown by the finding that NONS treatment was well tolerated. None of the patients reported any adverse effects that were serious or severe. Methemoglobin levels did not alter clinically from baseline, indicating that the nasal spray’s nitric oxide was not available systemically. Additionally, neither therapy showed indicators of systemic vasodilation nor nasal vasodilation.
Strategic Partnership with SaNOtize
To manufacture, market, and distribute its ground-breaking 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, Glenmark and Canadian biotech company SaNOtize entered into an exclusive long-term strategic partnership in July 2021.
Global NONS Approvals
After getting manufacturing and marketing permission from the Drugs Controller General of India (DCGI) as part of the expedited approval procedure, Glenmark introduced NONS under the trade name FabiSpray® in February 2022. In Europe, NONS has already been granted a CE mark, which is the equivalent of a marketing authorisation for medical devices.
NONS is also approved and being sold in Singapore, Hong Kong, Israel, Thailand, Indonesia and Bahrain, under the name enovid™ or VirX™. Outside of India, NONS has also been approved globally for protection against viruses, including SARS COV-2.