SaNOtize, the company behind an antiviral nasal spray for use against COVID-19, announced this week it has signed an agreement with Indian firm Glenmark Pharmaceuticals, to make the company’s breakthrough Nitric Oxide Nasal Spray (NONS) available in India and other Asian markets including Singapore, Malaysia, Hong Kong, Taiwan, Nepal, Brunei, Cambodia, Laos, Myanmar, Sri Lanka, Timor-Leste, and Vietnam.
SaNOtize, co-founded by Israeli-Canadian scientist Dr. Gilly Regev and based in Vancouver, developed a patented platform technology that allows for the topical delivery of nitric oxide (a naturally occurring nanomolecule with the formula NO, hence the name) to treat a variety of bacterial, fungal, and viral diseases.
SaNOtize’s clinical trials in March 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 approximately 95 percent and then by more than 99 percent within 72 hours. It has been tested in healthy volunteers and patients as part of UK and Canada clinical trials.
Available as a simple nasal spray, it is designed to kill the virus in the upper airways, preventing it from incubating and spreading to the lungs.
Last month, Glenmark presented a proposal to the Subject Expert Committee of India’s Central Drugs Standard Control Organisation (CDSCO) for emergency approval for the import and marketing of the nasal spray. The committee has recommended a Phase III clinical trial to be conducted in Indian patients in the weeks to follow. The Phase III clinical trial for NONS is expected to be completed, followed by a commercial launch, by the fourth quarter of 2021.
“Our efforts since the beginning of COVID-19 have been to provide patients with safe and effective treatment options to fight the disease. This partnership with SaNOtize closely aligns with Glenmark’s focused approach against COVID-19 and will help reduce the burden of the pandemic in the region,” said Glenn Saldanha, chairman & MD, Glenmark Pharmaceuticals Ltd.
“COVID-19 and its various variants are proving to be a challenge to contain despite the rapid – and critical – development of vaccines,” said Dr. Regev, CEO and co-founder of SaNOtize. “In joining forces with Glenmark, SaNOtize can accelerate the efforts to have its antiviral nasal spray available as a self-administered, first line of defense against COVID-19 during the current pandemic and to help prevent future outbreaks.”
“It also marks another valuable in-licensing opportunity for us in our key therapy area of respiratory medicine, as well as the possibility to globally supply the product to SaNOtize and its partners outside of our territory. Glenmark will ensure timely and widespread access to this effective nasal spray, which we hope will bring much-needed relief to patients across the region and the wider world,” added Saldanha.
NONS has already received a CE mark in Europe, which is the equivalent of marketing authorization as a medical device. With the CE mark, SaNOtize has permission to launch NONS in the EU. NONS has also been approved and is being sold in Israel and Bahrain, under the name Enovid.
Earlier this year, Enovid was granted an emergency use authorization as a medical device by Israel’s Ministry of Health and began a local production line. It has been approved for people 12 years of age and older.