Glenmark Pharmaceuticals and SaNOtize have announced the publication of results from a Phase 3 clinical trial of NONS nitric oxide nasal spray for the treatment of COVID-19 in The Lancet Regional Health Southeast Asia. SaNOtize announced initiation of the Phase 3 trial in June 2021, and Glenmark announced in August 2021 that it had acquired the rights to NONS in India and other Asian countries.
The study, which took place during surges of the delta and omicron variants in India, enrolled 306 patients aged 18 to 70 with mild COVID-19 symptoms who were randomized to get either NONS or placebo over 7 days. According to the companies, self-administered NONS 6 times per day significantly reduced viral load compared to placebo, with 7 times greater reduction at 48 hours compared to placebo. In patients considered at high risk, NONS reduced the viral load by ~94% within 24 hours, similar to results from a previous Phase 2 trial. In addition, median time to negative PCR test for patients using NONS was 3 days compared to 7 days for placebo.
SaNOtize CEO Gilly Regev commented, “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 cells of 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.”
SaNOtize Chief Scientific Officer Chris Miller added, “As we grapple with waning vaccine efficacy, mixed results from antiviral drugs and evolving variants of concern, there is an increasing need for effective and safe COVID-19 therapies. To our knowledge, no other outpatient antiviral therapy has led to negative PCR conversion as quickly as NONS. The study data demonstrate the use of NONS to treat people with COVID-19 who are at risk for disease progression. The fact that NONS was effective, well tolerated, and rapidly reduced viral load suggests it may be a powerful weapon in the armamentarium required to manage COVID-19 and prevent future outbreaks.”
Glenmark Senior VP and Head of Clinical Development Monika Tandon said, “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.”
According to SaNOtize, NONS is currently marketed as Enovid in Israel, Indonesia, and Bahrain and as VirX in Thailand. The nasal spray has received the CE mark in the EU and is registered as a Class I medical device in Hong Kong, Singapore and Nepal. India’s Central Drugs Standard Control Organization (CDSCO) granted emergency use approval for NONS in February 2022.
Read the Glenmark press release.
Read the SaNOtize press release.
