Glenmark and SaNOtize announce positive Results from Phase 3 Clinical Trial of NONS (FabiSpray®) in Non-Hospitalized Adult Indian Patients with COVID-19

• Phase 3 trial in India met the key endpoints and demonstrated reduction of viral load of 94% in 24 hours and 99% in 48 hours.
• NONS was safe and well tolerated in COVID-19 patients.
• Glenmark received manufacturing and marketing approval from India's drug regulator for Nitric Oxide Nasal Spray (NONS) as part of accelerated approval process.
• Glenmark to market NONS under the brand name FabiSpray® in India.
• Glenmark plans to launch NONS in other Asian markets in partnership with SaNOtize.

MUMBAI, India and VANCOUVER, BC, Feb. 9, 2022 /PRNewswire/ -- Glenmark Pharmaceuticals Limited (Glenmark) – a global, innovation-driven pharmaceutical company and Canadian pharmaceutical company SaNOtize Research & Development Corp. announced top-line results from a Phase 3 clinical trial in adult COVID-19 patients conducted across 20 clinical sites in India. The double-blind, parallel arm, multicenter study, conducted in 306 patients evaluated the efficacy and safety of Nitric Oxide Nasal Spray versus normal saline nasal spray in non-hospitalized adult patients. The trial also analyzed patients with risk of progression of disease - non-vaccinated patients, patients in the middle and older age group and patients with co-morbidities. All patients received standard supportive care in the study.

FabiSpray®

FabiSpray®, Nitric Oxide Nasal Spray, is designed to kill the COVID-19 virus in the upper airways. It has proven anti-microbial properties with a direct virucidal effect on SARS-CoV-2. NONS when sprayed over nasal mucosa acts as a physical and chemical barrier against the virus, preventing it from incubating and spreading to the lungs.

Indian Phase 3 Clinical Trial Outcomes

• The trial analyzed patients with risk of progression of disease - non-vaccinated patients, patients in the middle and older age group and patients with co-morbidities. Primary endpoint was met: Reduction in log viral load in the NONS group was statistically significant and superior to the control (placebo) group (p < 0.05).
• The median time to virological cure was 4 days in the NONS group and 8 days in the placebo group (p < 0.05).
• A significantly higher proportion of patients demonstrated a 2-point improvement on the WHO Progression Scale (validated clinical end-point) in the NONS group as compared to the placebo group (p < 0.05).
• NONS was safe and well tolerated by patients. No patients experienced moderate, severe, serious Adverse Events (AE) or death in the study.

Dr. Monika Tandon, Senior VP & Head - Clinical Development, Glenmark Pharmaceuticals Ltd., commented: "The results from this Phase 3, double blind, placebo controlled trial are encouraging. Demonstration of reduction in the viral load has significant positive impact from a patient and community perspective. In the current scenario, with new emerging variants exhibiting high transmissibility, NONS provides a useful option in India's fight against COVID-19."

"SaNOtize is pleased to announce these results - which further substantiate the efficacy of our product as demonstrated by Phase II trials in the UK - with our global partner, Glenmark," 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 faster cure, as compared to control. And with the proven strong safety profile of this treatment, we look forward to this becoming the first line of treatment, if not defense, for COVID infection worldwide."

In March 2021, clinical trials from SaNOtize showed NONS was a safe and effective antiviral treatment of SARS CoV-2. In the first 24 hours, NONS reduced the average viral load by around 95%, and then by more than 99% within 72 hours. (In the India Phase 3 trial, a reduction of viral load of 94% in 24 hours and 99% in 48 hours was similar to reduction seen in the UK NHS trial conducted by SaNOtize). NONS has been tested in healthy volunteers and patients as part of Canada and UK clinical trials. SaNOtize has an ongoing global Phase 3 prevention trial, which will further add to its efficacy. As per studies conducted in the Utah State University USA, NONS is proven to kill 99.9% of SARS-Cov-2 virus including Alpha, Beta, Gamma, Delta, and Epsilon variant within 2 minutes. The Phase 3 clinical trial for NONS is now completed by Glenmark, and is being followed by the commercial launch of this NONS under the brand name FabiSpray® in India. Following this, Glenmark plans to launch NONS in other Asian markets in partnership with SaNOtize. Glenmark also plans to submit the clinical trial data for publication in a peer-reviewed journal in order to share its findings.

Strategic Partnership with SaNOtize

In July 2021, Glenmark entered into an exclusive long term strategic partnership with Canadian biotech firm SaNOtize, to manufacture, market and distribute its breakthrough Nitric Oxide Nasal Spray for COVID-19 treatment in India and other Asian markets including Singapore, Malaysia, Hong Kong SAR, Taiwan Region, Nepal, Brunei, Cambodia, Laos, Myanmar, Sri Lanka, Timor-Leste and Vietnam. 

Global Approvals for NONS

NONS has already received a CE mark in Europe, which is an equivalent of marketing authorization in case of a Medical Device. By virtue of the CE mark, SaNOtize has permission to launch NONS in the EU. NONS is also approved and being sold in Israel, Singapore, Thailand, Indonesia and Bahrain, under the name enovid™ or VirX^™.  NONS is approved in many counties for protection against viruses including SARS COV-2.

About Glenmark Pharmaceuticals Ltd 

Glenmark Pharmaceuticals Ltd. (GPL) is a global innovation-driven pharmaceutical company with presence across Specialty, Generics and OTC businesses. 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.

About SaNOtize Research & Development Corp.

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 (NORSTM) to treat and prevent upper respiratory and topical infections.