SaNOtize and ECRAID-Prime have signed a collaboration agreement to begin the first study of SaNOtize’s antiviral nitric oxide nasal spray (NONS), using Europe’s adaptive platform trial in primary care. This phase IIb study is set to begin recruitment in Q3/4 2023 and aims to assess the efficacy of NONS versus intranasal saline in patients with COVID-19 and COVID-like illness. The study will be conducted in seven European countries: Belgium, France, Germany, Ireland, Poland, Spain, and the UK.
Participants in the recent study included 625 students at a university in Thailand that was undergoing quarantine for an Omicron outbreak. Those with confirmed exposure to COVID-19 were offered the option to take nitric oxide nasal spray (NONS™) as a possible preventive measure against infection. Those who chose to use NONS™ (203 participants) sprayed it intranasally at least four times daily (422 volunteers chose not to use NONS). The infection rate in participants who took NONS™ was 6.4% versus 25.6% in the control group (P<0.0001), representing a significant reduction in infection risk of 75%.
This study was a randomized, double-blind, placebo-controlled study that took place at 20 clinical sites across India and enrolled 306 patients who had contracted COVID-19. In the NONS™ treatment group, the SARS-CoV-2 viral load was reduced by more than 94% within 24 hours of treatment, and by more than 99% in 48 hours, compared to participants using a saline nasal spray (placebo). The median time to a negative PCR test in this group was four days in the treatment group compared with eight days in the control.
Data was published in THE LANCET Regional Health Southeast Asia:
This randomized, double-blind, placebo-controlled trial evaluated use of NONS in early treatment of 80 confirmed cases of COVID-19 in the UK. Use of NONS™ 5-6 times daily for nine days significantly reduced participants’ levels of SARS-CoV-2, the virus that causes COVID-19, including in participants with high viral loads. For participants using NONS™, the average viral load reduction in the first 24 hours was 95%, and with 72 hours, the viral load dropped by more than 99%. Resolution of symptoms was also faster on NONS treatment than on placebo.
Data was published at the Journal of Infection:
SaNOtize is planning a Phase II efficacy study to evaluate its nitric oxide releasing sinus irrigation (NOSi) as a treatment for recurrent acute rhinosinusitis. This double-blinded, placebo controlled clinical trial has been submitted to Health Canada.
SaNOtize has completed enrollment for a Phase I/II efficacy studies that evaluated its nitric oxide releasing sinus irrigation (NOSi) as a treatment for recalcitrant chronic sinusitis. It was found to be safe and tolerated in the initial dosing study. In the double-blinded, comparative active drug controlled clinical trial under the auspices of Health Canada, the results demonstrated NOSi safety and an improvement in clinical outcome measures as compared to the subject’s own baseline status but not a statistically significant difference as compared to a maximum daily dose of budesonide over the 6 week treatment regimen. During the 3 week follow up, subjects continued to improve to a statistically significant clinical difference on NOSi, whereas the budesonide cohort did not increase improvement. These results justify further exploration in SaNOtize’s drug development program.
SaNOtize has recently completed recruitment of patients for a Phase I/II efficacy study to evaluate its nitric oxide releasing footbath as a treatment for diabetic foot ulcer. This double-blinded, placebo controlled clinical trial is Health Canada-approved and funded by a grant from the U.S. Department of Defense. The treatments were well tolerated, and results are anticipated for the early fall of 2023.
Clinical trial registry: Nitric Oxide Footbath for Treatment of Diabetic Foot Ulcers
SaNOtize is planning a Phase IIa efficacy study to evaluate its nitric oxide releasing footbath as a treatment for plantar warts. This double-blinded, placebo controlled clinical trial is Health Canada-approved.