Canadian Firm Explores Potential Of Nasal Spray In COVID-19 Prevention

SaNOtize and partner Glenmark’s Phase III trial of NONS in India met its key endpoints and demonstrated a sharp reduction in SARS-CoV-2 viral load in high-risk COVID-19 patients.

The primary outcome measure of nasal SARS-CoV-2 RNA accelerated clearance was used to assess the efficacy of NONS in high-risk patients after seven days of treatment. An exploratory evaluation of NONS in prevention of infection in immediate contacts of the COVID-19 patients was also done.

Trial participants in the randomized, double-blind, placebo-controlled study conducted by Glenmark were assigned to self-administer either two sprays of NONS per nostril six times a day over seven-days or saline spray (active placebo) in the same administration schedule. All participants had access to standard supportive care.

The study findings, published in The Lancet Regional Health Southeast Asia, indicated that in high-risk participants, NONS reduced the SARS-CoV-2 log viral load in COVID-19 patients by 93.7% within 24 hours of treatment and by 99% in 48 hours, compared to baseline. 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 median time to a negative PCR test in the treatment group was three days versus seven days after treatment initiation in the placebo group (P <>

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 partners indicated.

The data were submitted to the Indian regulator, which granted emergency use approval to NONS in February for treatment of adult patients with COVID-19 who have a risk of progression of the disease. (Also see "Watch This Space: Glenmark-SaNOtize’s COVID-19 Nasal Spray Debuts In India" - Scrip, 10 February, 2022.)(Also see "SaNOtize, Lupin In Legal Row Concerning COVID-19 Nasal Spray" - Scrip, 14 February, 2022.)

The study covered 306 participants with mild COVID-19 symptoms, confirmed with a PCR test for SARS-CoV-2, across 20 clinical sites in India. Participants were enrolled irrespective of their vaccination status (around 46% were vaccinated) and included a sub-group of 208 with a high risk of disease progression, including non-vaccinated participants or those at least 45 years of age and/or with co-morbidities.

Glenmark’s senior vice president and head, clinical development, Dr Monika Tandon said that the trial demonstrated “significant efficacy and remarkable safety” of NONS. The therapy, she declared, 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.

A prominent infectious disease specialist from India tracking the developments told Scrip that nasal nitric oxide is an “attractive option” and is now generating an evidence base both in treatment and prevention of COVID-19. “Early results in COVID-19 appear promising but better validation is needed," the specialist, however, added.

In addition to the India authorization, NONS is also approved and being sold in Singapore, Hong Kong, Israel, Thailand, Indonesia and Bahrain, under the Enovid or VirX brands. It has received a CE mark in Europe, which the partners explained is an equivalent of marketing authorization in the case of a medical device.

SaNOtize’s partner Cytori is also “doing its best” to try and move forward the registration for the product in Japan, CEO Regev told Scrip.