The Lancet Regional Health Southeast Asia publishes the successful phase 3 clinical trial results of nitric oxide nasal spray.

Phase 3 trial of nitric oxide nasal spray administered to adult COVID-19 patients in India met the key endpoints and demonstrated reductions of viral load of 94% in 24 hours and 99% in 48 hours. Nitric oxide nasal spray was safe and well tolerated in COVID-19 patients. Following positive results and regional approvals, Glenmark launched this nasal spray in India under the brand name FabiSpray and in Singapore and Hong Kong under the brand name VirX .

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, a 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 Nitric Oxide Nasal Spray (NONS) treatment: A randomised 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 a 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 the WHO Clinical Progression Scale Score and extent/rapidity of virologic recovery were 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 the 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 the viral load is reduced so rapidly with NONS.

The 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 design

The study was conducted by Glenmark on 306 vaccinated and non-vaccinated adults with 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 primary outcome measure of nasal SARS-CoV-2 RNA accelerated clearance was used to assess the efficacy of this transformational NONS in high-risk patients (unvaccinated, or 45 years of age, or had one or more comorbidities) after seven days of treatment. Exploratory evaluation of NONS in the prevention of infection in immediate contacts of these COVID-19 patients was also evaluated.

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. There were no clinically significant changes from baseline observed in methemoglobin suggesting a lack of systemic availability of nitric oxide from a nasal spray. Additionally, neither nasal vasodilation symptoms nor systemic vasodilation signs were observed in either treatment.

Strategic partnership with SaNOtize

In July 2021, 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.

Global approvals for NONS

Glenmark launched NONS under the brand name FabiSpray in February 2022, after receiving manufacturing and marketing approval from the Drugs Controller General of India (DCGI) as part of the accelerated approval process. NONS has already received a CE mark in Europe, which is the equivalent of marketing authorisation in the case of a Medical Device.

By virtue of the CE mark, SaNOtize has permission to launch NONS in the EU. NON 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.