A nasal spray to target SARS-CoV-2 in the upper airways is likely to be available in India later this year, following a tie-up between Glenmark Pharmaceuticals and Canadian biotech firm SaNOtize Research & Development Corp.

The exclusive, long-term alliance allows Glenmark to manufacture, market and distribute SaNOtize’s Nitric Oxide Nasal Spray (NONS) for Covid-19 in India and other Asian markets, including Singapore, Malaysia, Hong Kong, Taiwan, Nepal, Brunei, Cambodia, Laos, Myanmar, Sri Lanka, Timor-Leste and Vietnam.

Glenmark will undertake advanced clinical trials in India, and expects to launch the novel product in the last three months of 2021.

Works against variants

Dr Monika Tandon, Glenmark’s Senior Vice-President (Clinical Development), told BusinessLine the trial will involve about 300 ëarly non-hospitalised patients”. The product has been categorised in different geographies as a preventive or for early treatment, she said. The product is known to work against the variants as well, she said, stressing on the importance of making it available even as a third wave was imminent.

The spray would be used about five times a day in treatment and twice a day as a preventive, she said, adding that it has a low concentration of nitric oxide.

In early July 2021, Glenmark presented a proposal to the Subject Expert Committee of CDSCO for emergency approval for import and marketing of the nasal spray. The committee recommended a Phase III clinical trial to be conducted in Indian patients in the weeks to follow.

In March 2021, SaNOtize’s clinical trials showed NONS was a safe and effective antiviral treatment to prevent the transmission of Covid-19, shorten its course, and reduce the severity of symptoms. In the first 24 hours, NONS reduced the average viral load by around 95 per cent, and then by more than 99 per cent within 72 hours, a note from Glenmark said.

It has been tested in healthy volunteers and patients as part of clinical trials in the UK and Canada. “Available in the form of a simple nasal spray, it is designed to kill the virus in the upper airways, preventing it from incubating and spreading to the lungs. It is based on nitric oxide (NO), a natural nanomolecule with proven anti-microbial properties, and which has a direct effect on SARS-CoV-2, the virus causing Covid-19,” Glenmark added.

NONS has already received a CE mark in Europe. It is approved and being sold in Israel and Bahrain. SaNOtize developed and patented a Nitric Oxide Releasing Solution platform technology (NORSTM) to treat and prevent microbial infections in 2017.

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