A nitric oxide nasal spray (NONS) approved for the treatment of Covid-19 in India is being tested to be used for prevention in the future, says SaNOtize CEO and co-founder Gilly Regev, presenting a simple alternative to people wanting to protect themselves from the virus especially in a populous country where high cost treatments are a challenge.
Multiple variants and waves of Covid have shown vaccines alone won’t be enough to control the virus. Pharma companies are working on drugs and other effective treatment options to reign in the virus that has infected more than 400 million people around the world in over two years. In India, government data shows more than 42 million people have tested positive for Covid so far.
SaNOtize’s NONS FabiSpray, launched in India last week in partnership with Glenmark, was approved by the drug regulator, Drugs Controller General of India, for the treatment of adult Covid-19 patients with a risk of progression of the disease. In its phase III trials, the spray demonstrated it reduced Covid-19 viral load by 94% in 24 hours and by 99% in 48 hours. The trial confirmed NONS was an effective antiviral treatment that shortens the course of Covid-19 and could prevent its transmission, SaNOtize said in a statement.
Regev says the company is conducting a large prevention trial with a goal that everyone can use it in the future. “The difference with other treatments, like antiviral pills (is that) those are not meant to be taken daily. They cannot be used for prevention. This nasal spray has a strong safety profile and there is nothing to prevent you from using it daily or every time after you're outside to prevent getting the disease,” she told Fortune India.
Sanitiser for the nose
Regev says the spray was initially developed to treat influenza several years ago, but a lengthy drug trial process in various countries has led to a delay in bringing it to market for Covid-19. In the European Union, like in India, the spray has been approved as a medical device, which meant the approval process was faster, compared to drug trials. In some countries, regulation will require it to be approved as a drug as nitric oxide was previously approved to use for babies as a drug, says Regev.
“The way we deliver nitric oxide, it's a much lower dose, it's very safe. The drug approval is longer, you have to do a lot more trials, you have to spend a lot more money and unfortunately, it takes longer... This is a topical, non-systemic, low dose of nitric oxide, some countries are allowing it as a medical device, for which the bar is not as high to show clinical trials. And you can get it to the market earlier,” she says.
The spray releases a small amount of nitric oxide into the nose that acts as an anti-infective; it kills the virus in the upper airways, preventing it from incubating and spreading to the lungs.
“We call it the hand sanitiser for the nose. The idea was that people could carry it in their pockets and use it to prevent getting the disease. If you get infected and the virus sits in your nose and starts multiplying, the nasal spray will reduce the viral load to a point that it won't cause a disease,” Regev says over a Zoom call, adding that in some countries, it has already been allowed to be used as a preventative measure over the counter for people aged 12 and above.
Open to partnerships
SaNOtize has a licensing agreement with Glenmark for manufacturing and distribution in India and certain other Southeast Asian countries.
The spray was initially approved for usage in Israel, where the company has significantly amped up production. It is now working on partnerships in other parts of the world.. “We have contracted a strong manufacturer in the U.S. and we've been working together for the last six months to ramp up manufacturing there,” she says. The company is also in talks with Health Canada and Medicines and Healthcare products Regulatory Agency (MHRA-UK) for emergency approval.
In India, the company says it is in partnership talks on more products with Glenmark, but is open to deals with other companies for products like its acne cream and a nasal lavage for sinusitis.
“We are discussing potential future partnerships on other products that SaNOtize is developing... the partnership with Glenmark will give them the first priority but we are open to discussions (with other groups) and we are hoping that this is just the first product of many,” Regev adds.
