Mallinckrodt and Novoteris announced that the Therapeutic Products Directorate of Health Canada has cleared the companies’ joint pilot clinical trial, entitled “Inhaled Gaseous Nitric Oxide (gNO) Antimicrobial Treatment of Difficult Bacterial and Viral Lung (COVID-19) Infections” application to investigate the use of Thiolanox, a high-dose inhaled nitric oxide therapy for the treatment of patients infected with novel coronavirus (SARS-CoV-2) at Vancouver Coastal Health Authority facilities. The investigative therapy employs Novoteris’ Inhaled Nitric Oxide Delivery Device (INODD) and Mallinckrodt’s high-concentration, 5000 PPM nitric oxide gas for inhalation canisters. The study will investigate the therapy’s safety and effectiveness in treating COVID-19 and its associated lung complications. The companies expect to begin recruiting patients in the coming days.
“Inhaled nitric oxide may have an antiviral effect, as well as improve oxygenation and pulmonary arterial pressure in patients suffering from COVID-19,” Steven Romano, MD, Executive Vice President and Chief Scientific Officer at Mallinckrodt, said in a company news release. “We’re proud to be partnering with Novoteris on this pilot trial and are committed to increasing understanding of this potentially important therapeutic option for healthcare providers on the front lines of this unprecedented health emergency.”
“This is an important day for patients and healthcare providers,” said Chris Miller, PhD, Assistant Professor, Faculty of Medicine at University of British Columbia and Founder and Scientific Advisor at Novoteris. Dr. Miller, team lead for the study at Vancouver Coastal Health Research Institute, and an expert in nitric oxide therapies with a research career spanning more than 25 years studying the antimicrobial effect of high-dose nitric oxide to treat lung infections, said, “I am very pleased to be working with Mallinckrodt and Novoteris on this study using high-dose inhaled nitric oxide for patients with COVID-19.”
Mallinckrodt is currently working with the FDA on the possibility of making the company’s INOmax (nitric oxide) gas, for inhalation product available to U.S. patients with pulmonary complications of COVID-19 as quickly as possible through the appropriate regulatory mechanism. INOmax has been on the market in the U.S. since 2000, and is indicated for the treatment of term and near-term neonates with hypoxic respiratory failure associated with pulmonary hypertension.