Glenmark Pharmaceuticals and SaNOtize Announce Peer-Reviewed Publication of Its Phase 3 Clinical Trials of SaNOtize’s Novel Nitric Oxide Nasal Spray for COVID-19 in The Lancet Journal

Mumbai, India and VANCOUVER, BC, July 13, 2022 /PRNewswire/ — Glenmark Pharmaceuticals Limited (Glenmark), an innovation-driven global pharmaceutical company and SaNOtize Research and Development Corp, today announced that The Lancet Regional Health Southeast Asia (TLRHSEA) – A high-impact, peer-reviewed journal has published the successful Phase 3 clinical trial results of the SaNOtize Nitric Oxide Nasal Spray (NONS) study titled: “SARS-CoV Accelerated Reporting -2 using a new nitric oxide nasal spray (NONS) treatment: a randomized trial”.

https://www.thelancet.com/journals/lansea/article/PIIS2772-3682(22)00046-4/fulltext

“We are delighted to publish the study of the novel Nitric Oxide Nasal Spray, which has a positive impact on people’s lives, in The Lancet review group. The robust double-blind trial demonstrated significant efficacy and safety remarkable contribution from NONS. This therapy has the potential to make a critical contribution to the management of COVID-19, with its ease of use in the current highly transmissible phase of the pandemic,” said Dr. Monika TandonSenior Vice President and Head of Clinical Development, Glenmark Pharmaceuticals Ltd.

The study demonstrated that patients who received NONS had a significant reduction in viral load within 24 hours, which was maintained for seven days of treatment. Viral load was reduced by 93.7% within 24 hours and by 99% within 48 hours of treatment with NONS. The mean change from baseline in logarithm of viral RNA load over the entire course of treatment was statistically greater with NONS than with placebo. Similar results were observed in vaccinated and unvaccinated populations. The study was conducted during delta and omicron surges. Key secondary endpoints, including clinical improvement as assessed by WHO Clinical Progression Scale score and extent/speed of virologic recovery, were demonstrated in patients using NONS. The median time to virological cure was three days in the NONS group and seven days in the placebo group after the start of treatment (four days earlier). The exploratory assessment of the proportion of immediate contacts testing positive for COVID-19 or becoming symptomatic remained almost the same in the NONS group while it increased numerically in the placebo group during treatment.

“The Phase 3 study results strongly support the safety and efficacy of NONS in the treatment of COVID-19 and its known variants,” said Gilly Regev, PhD, SaNOtize Co-founder and CEO. “Nitric oxide blocks entry into the nasal passage, kills the virus and stops its replication, which is why viral load is reduced so quickly with NONS. Viral load has been linked to infectiousness, poorer health outcomes and complications from long COVID. Evidence is accumulating that NONS represents an effective and well-tolerated antiviral therapy that significantly shortens the course of COVID-19. »

study design

The study was conducted by Glenmark on 306 vaccinated and unvaccinated adults with mildly symptomatic COVID-19 at 20 clinical sites in India. This randomized, double-blind Phase 3 clinical trial evaluated a seven-day course of NONS plus standard therapy versus placebo nasal spray plus standard therapy in patients with symptomatic COVID-19. The primary endpoint of accelerated clearance of nasal SARS-CoV-2 RNA was used to assess the efficacy of this transformational NONS in high-risk patients (unvaccinated, or aged 45, or having one or more comorbidities) after seven days of treatment . The exploratory evaluation of NONS in preventing infection in immediate contacts of these COVID-19 patients was also assessed.

NONS treatment was well tolerated, establishing a benefit of locally acting nasal therapy. None of the patients reported moderate or severe side effects. There were no clinically significant changes from baseline observed in methemoglobin suggesting a lack of systemic availability of nitric oxide from the nasal spray. In addition, no symptoms of nasal vasodilation or signs of systemic vasodilation were observed in either treatment.

Strategic partnership with SaNOtize

In July 2021Glenmark has entered into an exclusive long-term strategic partnership with Canadian biotech company SaNOtize, to manufacture, market and distribute its breakthrough nitric oxide nasal spray for the treatment of COVID-19 in India and other Asian markets, including Singapore, Malaysia, hong kong, Taiwan, Nepal, Brunei, Cambodia, Laos, Burma, Sri LankaTimor-Leste and Vietnam.

Global approvals for NONS

Glenmark launched NONS under the FabiSpray® brand in February 2022after having received manufacturing and marketing approval from the Comptroller General of Medicines of India (DCGI) under the Accelerated Accreditation Process. NONS has already received the CE mark in Europe, which is equivalent to a marketing authorization in the case of a medical device. Under the CE mark, SaNOtize is authorized to launch NONS in the EU. NONS is also approved and sold in Singapore, hong kong, Israel, Thailand, Indonesia and Bahrain, under the name enovid™ or VirX™. Apart from IndiaNONS has also been approved globally for protection against viruses including SARS COV-2.

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SOURCEGlenmark Pharmaceuticals Ltd.