Canadian biotech firm SaNOtize Research & Development Corp. has entered into an exclusive long-term agreement with Glenmark Pharmaceuticals Ltd. for manufacturing, marketing and distribution of its nitric oxide nasal spray (NONS) used to treat COVID-19 in India.
Glenmark would also be handling other Asian markets, including Singapore, Malaysia, Hong Kong, Taiwan, Nepal, Brunei, Cambodia, Laos, Myanmar, Sri Lanka, Timor-Leste and Vietnam.
“In March, 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,” Glenmark said in a statement.
“In the first 24 hours, NONS reduced the average viral load by around 95%, and then, by more than 99% within 72 hours. It has been tested in healthy volunteers and patients as part of U.K. and Canada clinical trials,” it said.
Available in the form of a 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 nano- molecule with proven anti-microbial properties, and which has a direct effect on SARS-CoV-2, the virus causing COVID-19, the company said.
In early July 2021, Glenmark had presented a proposal to the Subject Expert Committee of CDSCO for emergency approval for 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,” Glenmark said.
The Phase III clinical trial for NONS is expected to be completed, followed by commercial introduction under the brand name FabiSpray in India, by fourth quarter of the calendar year 2021.
“Our efforts since the beginning of COVID-19 have been to provide patients with safe and effective treatment options to fight the disease,” said Glenn Saldanha, chairman and MD, Glenmark Pharmaceuticals Ltd.
“This partnership with SaNOtize closely aligns with our focused approach against COVID-19 and will help reduce the burden of the pandemic in the region,” he said.
“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,” he said.
“COVID-19 and its various variants are proving to be a challenge to contain despite the rapid and critical development of vaccines,” said Gilly Regev, CEO and co-founder, 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 defence against COVID-19 during the current pandemic and to help prevent future outbreaks,” she said.
NONS is one of the few novel therapeutic treatments, outside of expensive monoclonal antibodies, that is proven to reduce SARS-CoV-2 viral load in humans, Glenmark said.