Nitric Oxide Nasal Spray Prevents Spread of Coronavirus, Clinical Trials Show

Nitric oxide is antibacterial andhas a proven direct effect on the new coronavirus.

Glenmark Pharmaceuticals, aresearch-led global integrated pharmaceutical company, and SaNOtize Research& Development Corp., a Canadian biotechnology company, announced anexclusive long-term strategic partnership in India and Singapore, Malaysia,Hong Kong, Taiwan, Nepal, Brunei, Cambodia, Other Asian markets including Laos,Myanmar, Sri Lanka, Timor-Leste and Vietnam manufacture, market and distributeits ground-breaking nitric oxide nasal spray for Covid-19 treatment.

In March 2021, SaNOtize's clinicaltrial showed that nitric oxide nasal spray is a safe and effective antiviraltreatment to prevent the spread of the new coronavirus, shorten its course andreduce the severity of symptoms. The nitric oxide nasal spray reduced averageviral load by about 95% in the first 24 hours and by more than 99% within 72hours. It has been tested in healthy volunteers and patients as part ofclinical trials in the UK and Canada. "The spray we developed is not onlya deterrent to the virus that causes COVID-19, but a killer," said Dr.Geely Regev, CEO and founder of SaNOtize, which developed the spray. Since mostCOVID-19 infections are the nose, SaNOtize believes this is an effective way toreduce the spread and infection of COVID-19.

Available as a simple nasal spray,the drug is designed to kill the virus in the upper respiratory tract before itcan grow and spread to the lungs. It is a natural nanomolecule nitric oxide(NO) that has been shown to have antibacterial properties. The spray usesnitric oxide as a mechanical and chemical barrier against nasal viralinfections, in which respiratory diseases such as COVID-19 penetrate the body.The spray is also effective against other respiratory viruses, such as thosethat cause the flu.

In early July 2021, Glenmarksubmitted a proposal to India's Central Drug Standards Control Organization(CDSCO) subject matter expert committee for emergency approval for the importand sale of nitric oxide nasal spray. The committee recommended a phase IIIclinical trial in Indian patients. Phase 3 clinical trials of the nitric oxidenasal spray are expected to be completed in the fourth quarter of calendar year2021, followed by commercial availability in India under the FabiSpray brandname.

"Since the outbreak ofCOVID-19, we have worked hard to provide patients with safe and effectivetreatment options to combat this disease. The collaboration with SaNOtize fitsclosely with Glenmark's primary approach to COVID-19 and will help reduce theburden of the outbreak in the region. ," said Glenn Saldanha, chairman andmanaging director of Glenmark Pharmaceuticals Ltd. He further added: "Thisalso marks another valuable in-licensing opportunity for us in the keyrespiratory medicine therapeutic area, as well as the possibility of supplyingthis product to SaNOtize and its partners globally. Glenmark will ensure timelyand widespread availability. With access to this potent nasal spray, we hope itwill bring much-needed relief to patients in the region and around theworld." "Despite rapid and critical vaccine development, COVID-19 andits various variants have proven to be a major challenge to containment.” saidGilly Regev, CEO and co-founder of SaNOtize. "SaNOtize is excited topartner with Glenmark to make its therapeutics simpler, more accessible andaffordable to more people. In working hand-in-hand with Glenmark, SaNOtize canaccelerate efforts to make its antiviral nasal spray Administer self-medicationas a first line of defense against COVID-19 during the current pandemic andhelp prevent future outbreaks."

Nitric oxide nasal spray is one ofthe few new treatments other than expensive monoclonal antibodies that havebeen shown to reduce the coronavirus load in humans. Nitric oxide nasal sprayhas been CE marked in Europe, which is equivalent to marketing authorizationfor a medical device (the CE marking confirms that a medical device meetscertain "essential requirements" of the European General MedicalDevice Directive and is safe for its intended use). With the CE mark, SaNOtizeis licensed to distribute nitric oxide nasal spray in Europe. Nitric oxidenasal spray is also licensed for sale under the name enovid^TM inIsrael and Bahrain.

SaNOtize developed and patented theNitric Oxide Release Solution Platform Technology (NORS^TM) for thetreatment and prevention of microbial infections in 2017. Glenmark'scollaboration with SaNOtize will bring much-needed therapeutic relief topatients in India and Asia.