A treatment for COVID-19 that was developed in British Columbia has been approved for sale in India, where it could be shipped to pharmacies as early as Friday – though the product has so far received limited support in Canada.
SaNOtize Research and Development Corp., a Vancouver-based pharmaceutical company, announced on 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 at reducing viral load in people with mild cases of COVID-19 and can help to prevent the disease from progressing, according to Phase 3 clinical trial results.
“It’s very exciting,” said Gilly Regev, chief executive officer 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 which predates the pandemic.
While the ability of nitric oxide to inhibit respiratory viruses has been demonstrated in hospital settings, the crucial innovation behind the SaNOtize nasal spray lies in a formulation that makes the gas practical as a self-administered treatment. It is not the only company to attempt this, but it is the first in the world to win a regulator’s 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 has already been available in some countries, including Israel, where it is categorized as a medical device.
SaNOtize said it also aims to seek regulatory approval for its product in Canada.
A randomized double blind trial of the spray was conducted at several 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 in a median time 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 sufficient to demonstrate whether the spray prevents hospitalization. However, its effects were more apparent in participants who have a higher risk of developing a serious case of COVID-19, including the unvaccinated, participants with co-morbidities such as diabetes and cardiovascular disease, and those older than 45. Participants who received the SaNOtize spray were also found to be less likely to spread the disease to others. She said the results are being prepared for submission to a peer-reviewed journal.
The findings from India are consistent with a smaller study conducted in Britain last year and published in the Journal of Infection. A larger trial which aims to recruit thousands of subjects in Canada, Sri Lanka and other countries is now under way to test how well the SaNOtize spray works at preventing COVID-19 in those who have not been infected.
“Our goal is to go for prevention,” Dr. Regev said. “The idea is that eventually people will use it to protect themselves.”
If the larger trial shows the spray prevents COVID-19, it could be used as a pre-emptive measure for health workers, travellers and others who face a high risk of exposure to respiratory viruses in a close setting. The spray would not be a substitute for vaccines but an enhancement to protection – one that could be especially relevant whenever new variants of COVID-19 emerge or in situations where people are gathering but the virus remains endemic.
This week’s milestone is a bittersweet one for SaNOtize, which had hoped to win more support to test and manufacture its product in Canada. In 2020, it received a $400,000 grant from the National Research Council – a fraction of the cost required to advance a medical treatment. Since then, SaNOtize has made a series of applications to 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 she has repeatedly been told SaNOtize is under consideration but no support has materialized.
“We’ve tried, we’ve submitted our applications, we’ve followed that with all the documents that were requested, and we haven’t got funding – those are the facts,” Dr. Regev said.
When asked why SaNOtize has so far not been successful at gaining Ottawa’s support, Hans Parmar, a spokesperson for Innovation, Science and Economic Development Canada, which oversees the Strategic Innovation Fund said details relating to applicants “are subject to commercial confidentiality and cannot be disclosed.”
Jeremy Hirota, who holds a Canada Research Chair in respiratory mucosal immunology at McMaster University in Hamilton and who is 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 are a little out of the mainstream dogma it is challenging, because you need to convert people.”
Dr. Regev said she thinks one problem may be that the idea of a nasal spray that prevents or treats COVID-19 sounds too good to be true.
Eleanor Fish, an infectious disease researcher with the University Heath Network in Toronto said that one challenge for the product may be getting people to apply it when directed. For example, trial subjects in India were asked to use the spray six times a day. In comparison, Pfizer’s antiviral pill, Paxlovid, is taken twice daily, but it is more than 10 times costlier than the nasal spray.
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