Canadian company SaNOtize’s COVID-19 treatment gains approval in India

A treatment for COVID-19 that was developed in British Columbia has been approved for sale in India, where it could ship to pharmacies as early as Friday – although the product has so far received limited support in Canada.

SaNOtize Research and Development Corp., a Vancouver-based pharmaceutical company, announced Wednesday that its nitric oxide nasal spray has received approval from India’s drug regulator. The product has been licensed for manufacture there by Glenmark Pharmaceuticals Ltd.

The spray is effective in reducing viral load in people with mild cases of COVID-19 and may help prevent disease progression, according to results from phase 3 clinical trials.

“It’s very exciting,” said Gilly Regev, CEO of SaNOtize, who co-founded the company with chief scientist Chris Miller. She said the approval was the result of years of work, much of it predating the pandemic.

Canadian company SaNOtize Research aims to limit the spread of COVID-19 with a nasal spray

While nitric oxide’s ability to inhibit respiratory viruses has been demonstrated in the hospital setting, the crucial innovation behind the SaNOtize nasal spray is a formulation that makes the gas convenient as a self-administered treatment. It’s not the only company to attempt this, but it’s the first in the world to win regulatory approval for a nitric oxide-based COVID-19 therapy.

Last August, Glenmark entered into an exclusive long-term partnership with SaNOtize to manufacture, market and distribute the spray as a COVID-19 treatment in India and several other Asian countries, including Singapore, Malaysia and Taiwan. The spray is already available in some countries, including Israel, where it is classified as a medical device.

SaNOtize said it is also aiming to gain regulatory approval for its product in Canada.

A randomized, double-blind trial of the spray was conducted at multiple clinical sites in India, involving a total of 306 participants. In the trial, those who received the SaNOtize spray were found to be virus-free within a median of four days. Those in the control group who received a placebo spray took about twice as long to clear the virus. There were no safety issues associated with the spray.

Dr Regev said the size of the study was not large enough to demonstrate whether the spray prevents hospitalization. However, its effects were more apparent in participants who have a higher risk of developing a severe case of COVID-19, including the unvaccinated, participants with comorbidities such as diabetes and cardiovascular disease, and those older. 45 years old. The SaNOtize spray was also found to be less likely to spread the disease to others. She said the results were being prepared for submission to a peer-reviewed journal.

India’s findings are consistent with a smaller study conducted in Britain last year and published in the Journal of Infection. A larger trial to enroll thousands of subjects in Canada, Sri Lanka and other countries is currently underway to test the effectiveness of SaNOtize spray in preventing COVID-19 in those who have not been infected.

“Our goal is to go for prevention,” Dr. Regev said. “The idea is that people will end up using it to protect themselves.”

If the larger trial shows the spray prevents COVID-19, it could be used as a preventative measure for health workers, travelers and others at high risk of exposure to respiratory viruses in a close setting. . The spray would not replace vaccines but an improvement in protection – an improvement that could be particularly relevant whenever new variants of COVID-19 emerge or in situations where people congregate but the virus remains endemic.

This week’s milestone is bittersweet for SaNOtize, which was hoping to get more support to test and manufacture its product in Canada. In 2020, he received a $400,000 grant from the National Research Council – a fraction of the cost required to advance medical treatment. Since then, SaNOtize has filed a series of applications with the Federal Strategic Innovation Fund.

In the 2020 federal budget, the fund was allocated $752 million to help Canadian companies working on medical countermeasures to COVID-19, including clinical trials and manufacturing capacity. Dr. Regev said he was repeatedly told that SaNOtize was being studied, but no support materialized.

“We tried, we submitted our applications, we followed that up with all the documents that were requested, and we don’t have funding – those are the facts,” Dr Regev said.

When asked why SaNOtize has so far failed to secure support from Ottawa, Hans Parmar, spokesperson for Innovation, Science and Economic Development Canada, which oversees the Strategic Innovation Fund , said nominee details “are subject to commercial confidentiality and may not be disclosed.”

Jeremy Hirota, Canada Research Chair in Respiratory Mucosal Immunology at McMaster University in Hamilton and not associated with SaNOtize, said the company’s situation is not unique.

“Funding agencies in Canada are quite conservative,” he said. “They pretty much want a guaranteed return on investment. If you’re a little outside the mainstream dogma, it’s a challenge, because you have to convert people.

Dr Regev said she thinks one problem might be that the idea of ​​a nasal spray that prevents or treats COVID-19 seems too good to be true.

Eleanor Fish, an infectious disease researcher at the University Heath Network in Toronto, said a challenge for the product could be getting people to apply it when directed. For example, test subjects in India were asked to use the spray six times a day. By comparison, Pfizer’s antiviral pill, Paxlovid, is taken twice a day, but is more than 10 times more expensive than the nasal spray.

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