A nasal spray to target SARS-CoV-2 in the upper airways, that’s the novel product that drugmaker Glenmark Pharmaceuticals seeks to bring into India through its latest alliance with Canadian biotech firm SaNOtize Research & Development Corp.

The exclusive, long term alliance allows Glenmark to manufacture, market and distribute SaNOtize’s Nitric Oxide Nasal Spray (NONS) for Covid-19 in India and other Asian markets including Singapore, Malaysia, Hong Kong, Taiwan, Nepal, Brunei, Cambodia, Laos, Myanmar, Sri Lanka, Timor-Leste and Vietnam.

Glenmark has sought regulatory clearance on the product and will undertake advanced clinical trials in India. It expects to launch it in the last three months of 2021, adding to its existing basket of Covid-19 products including anti-viral favipiravir.

Also read: Glenmark Life Sciences IPO subscribed 44 times

In March 2021, 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. In the first 24 hours, NONS reduced the average viral load by around 95 percent, and then by more than 99 percent within 72 hours, a note from Glenmark said.

It has been tested in healthy volunteers and patients as part of clincial trials in the United Kingdom and Canada.

“Available in the form of a simple 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 nanomolecule with proven anti-microbial properties, and which has a direct effect on SARS-CoV-2, the virus causing Covid-19,” a note from the company said.

SaNOtize’s “revolutionary” Covid-19 nasal spray is bolstered by Phase II trial data, it added.

Local trials

In early July 2021, Glenmark 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.

The Phase III clinical trial for NONS is expected to be completed, followed by commercial launch under the brand name FabiSpray® in India, by fourth quarter of the calendar year 2021.

Glenn Saldanha, Glenmark Pharmaceuticals Chairman and Managing Director, said it marks another valuable in-licensing opportunity in the 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.

Also read: Glenmark Life Sciences to cater to the global need for affordable APIs

“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,” 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 Dr Gilly Regev, Chief Executive and Co-founder of SaNOtize. “SaNOtize is excited to collaborate with Glenmark in providing broader, easier and affordable access to its treatment. 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.”

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. NONS has already received a CE mark in Europe, which is an equivalent of marketing authorization.

NONS is also approved and being sold in Israel and Bahrain, under the name enovidTM. SaNOtize developed and patented a Nitric Oxide Releasing Solution platform technology (NORSTM) to treat and prevent microbial infections in 2017.

Related Topics
comment COMMENT NOW