- Phase 3 trial reached primary endpoint and demonstrated a reduction in SARS-CoV-2 log viral load in COVID-19 patients by more than 94% within 24 hours of treatment, and by more than 99% in 48 hours
- Treatment also demonstrated, in the high-risk group (n=218), a greater proportion of patients who achieved a combination of clinical and virological cure, based on the WHO Progression Scale
- Median time to virological cure was 4 days in the treatment group, 8 days in the placebo group (p < 0.05).
- Glenmark receives manufacturing and marketing approval for Nitric Oxide Nasal Spray (NONS) as part of accelerated approval process
VANCOUVER, British Columbia & MUMBAI, India--(BUSINESS WIRE)--Canadian pharmaceutical company SaNOtize Research & Development Corp., (SaNOtize), and Glenmark Pharmaceuticals Limited (Glenmark), a global, innovation-driven pharmaceutical company, today announced successful results of Phase 3 clinical trials and approval from India�s drug regulator for the treatment of adult patients with COVID-19 who have a risk of progression of the disease.
The study confirmed that SaNOtize�s Nitric Oxide Nasal Spray (NONS) represents a safe and effective antiviral treatment that shortens the course of COVID-19, and could prevent the transmission of COVID-19.
In a randomized, double-blind, placebo-controlled, parallel-arm study at 20 clinical sites across India that evaluated 306 patients, NONS reduced the SARS-CoV-2 log viral load in COVID-19 patients by more than 94% within 24 hours of treatment, and by more than 99% in 48 hours as compared to saline control. Treatment also demonstrated, in the high-risk group (n=218), a statistically significant greater proportion of patients who achieved a combination of clinical and virological cure, based on the World Health Organization (WHO) Progression Scale. Moreover, the median time to negative PCR, in this group, was 4 days in the treatment group compared with 8 days in the control. Test subjects included patients infected with different variants, likely including Delta and Omicron. There were no significant adverse health events recorded in the Phase 3 trial, or in over 500 subjects treated so far with NONS in clinical trials.
The reduction in log viral load corroborates the reduction of viral load in the UK Phase 2 trials (a reduction of 95% in 24 hours and 99% in 72 hours), conducted in March 2021 by Ashford and St Peter�s Hospitals NHS Foundation Trust, and Berkshire and Surrey Pathology Services, and published in the Journal of Infection in August 2021.
"These results definitively substantiate the safety and efficacy of NONS in the fight against COVID-19,� said Dr. Gilly Regev, SaNOtize Co-Founder and CEO. �We are thrilled to be able to provide COVID patients with an affordable product that has been shown to deliver a faster cure. And with the proven safety profile of NONS, we look forward to this becoming the first line of treatment and potentially defense for COVID infection worldwide."
The SaNOtize treatment 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 produced by the human body with proven anti-microbial properties shown to have a direct effect on SARS-CoV-2, the virus that causes COVID-19. The pharmacology, toxicity, and safety data for NO use in humans has been well-established for decades. The NO molecule released from NONS is identical to the one delivered in its gaseous form to treat persistent pulmonary hypertension, or Blue Baby Syndrome, in newborn babies.
With the receipt of manufacturing and marketing approval from India�s drug regulator, SaNOtize�s strategic partner, Glenmark, will launch NONS commercially in India under the brand name FabiSpray�. The approval is for the treatment of adult patients with COVID-19 who have a risk of progression of the disease, which includes either persons over the age of 45, non-vaccinated people and/or those with comorbidities. Glenmark entered into an exclusive long-term strategic partnership with SaNOtize in August 2021 to manufacture, market and distribute NONS for COVID-19 treatment in India and other Asian markets including Singapore, Malaysia, Hong Kong, Taiwan, Nepal, Brunei, Cambodia, Laos, Myanmar, Sri Lanka, Timor-Leste and Vietnam.
NONS has a marketing authorization as a Class I Medical Device in the EU. NONS is also approved and being sold in Israel, Thailand, Indonesia and Bahrain, under the name enovid� or VirX�.
�As viral load is an important determinant of disease severity and transmission of COVID-19 infection, demonstration of reduction in the viral load is expected to have significant clinical consequences from a patient and community perspective,� said Dr. Monika Tandon, Senior Vice President and Head - Clinical Development, Global Specialty/Branded Portfolio for Glenmark. �In the current scenario, with new emerging variants exhibiting high transmissibility, this novel product provides a useful option in the world�s fight against COVID-19.�
Glenmark will submit the clinical trial data for publication in a peer-reviewed journal in order to share its findings.
Randomized, Double-Blind, Placebo-Controlled Phase 3 Trials - Details
- Patients in the Glenmark Phase 3 clinical trial in India self-administered a dose of 2 sprays per nostril, six times a day for a seven-day treatment period, along with standard supportive care.
- The primary and secondary outcome measures demonstrated the efficacy and safety of the NONS treatment arm over the control arm, which was administered normal saline nasal spray as placebo in double-blind manner.
- The trial also included a sub group analysis for patients with a high risk of disease progression, including either non-vaccinated patients, patients in middle- and older-age groups, and/or patients with co-morbidities.
- Reduction in log viral load in the NONS group was statistically significant and superior to the control group in the full population and high-risk population (p < 0.05). Similar results were seen in the un-vaccinated group. The primary endpoint was achieved and confirmed in all analyses.
- Significantly higher proportion of patients became negative on the RT-PCR test in the NONS group as compared to the placebo group. The time to virological cure was four days in the NONS group and eight days in the placebo group (p < 0.05).
- A significantly higher proportion of patients demonstrated a 2-point clinical status improvement on the WHO Progression Scale, the most clinically validated point system used in clinical trials, in the NONS group as compared to the placebo group in the high-risk group (p < 0.05).
- Data suggests role of NONS in prevention of COVID-19, which is consistent with a faster viral reduction.
- NONS was safe and well tolerated by all patients who were part of the clinical trial. There were no reports of moderate or severe or serious adverse events or death in the study. An independent Data and Safety Monitoring Board (DSMB) concluded that NONS was safe in COVID-19 patients.
�NONS destroys the virus, blocks entry into the nasal cavity and halts replication of the virus, which rapidly reduces viral load. This is important because viral load has been linked to infectivity, poor health outcomes and complications from Long COVID,� said Dr. Chris Miller, Chief Science Officer and co-founder of SaNOtize. �Amid evidence of waning efficacy for some vaccines and higher breakthrough rates, there is currently a lack of an antiviral therapy that is effective against COVID-19 and its variants that can be made widely and affordably available to the public. This is what makes NONS a critical weapon in ending the pandemic and preventing future outbreaks.�
About SaNOtize
SaNOtize Research & Development Corp. is a pharmaceutical company based in Vancouver, BC, commercializing the multi-faceted antimicrobial properties of a liquid producing nitric oxide. The company has developed and patented a Nitric Oxide Releasing Solution platform technology (NORS�) to treat and prevent upper respiratory and topical infections. For more information, visit www.SaNOtize.com. Click here for the company�s photo gallery.
About Glenmark Pharmaceuticals Ltd
Glenmark Pharmaceuticals Ltd. (GPL) is a global innovation-driven pharmaceutical company with presence across Specialty, Generics and OTC business. Globally, Glenmark focuses on the following key therapy areas: respiratory, dermatology and oncology. The company has 10 world class manufacturing facilities spread across 4 continents and operations in over 80 countries. It was ranked among the world�s top 50 Generics and Biosimilars companies (Top 50 Company Rankings, 2020, from Informa�s Generics Bulletin). The company has been listed on the Dow Jones Sustainability Index (DJSI), under the category of emerging markets for the fourth consecutive year in a row, most recently in 2021. DJSI is one of the world�s most respected and widely accepted sustainability benchmarks globally with only the top ranked companies in terms of Corporate Sustainability within each industry are featured in the index. For more information, visit www.glenmarkpharma.com.
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