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Mallinckrodt plc , a global biopharmaceutical company, and Novoteris, LLC, a clinical stage medical device and pharmaceutical developer focused on innovative nitric oxide gas applications, 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,” said Steven Romano, M.D., Executive Vice President and Chief Scientific Officer at Mallinckrodt. “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.”
COVID-19 is a contagious respiratory illness caused by a novel coronavirus. Patients with COVID-19 have mild to severe respiratory illness that can include symptoms such as cough, fever and shortness of breath.1 In severe cases, COVID-19 can cause acute respiratory distress syndrome (ARDS) – a disorder in which fluid leaks into the lungs, making breathing difficult or impossible – and can lead to multi-organ failure and sometimes death.1,2
“Our collaboration with Mallinckrodt to study high-dose inhaled nitric oxide to treat patients with COVID-19 and associated lung complications is an exciting step in both companies’ commitment to helping the world battle this global pandemic,” said Alex Stenzler, Founder and President at Novoteris.
Inhaled nitric oxide (iNO) has been evaluated in randomized controlled trials, both in pediatric and adult patients with ARDS,3,4,5,6,7 and demonstrated partially dose-dependent improvement in blood oxygenation and decreased pulmonary artery pressure3 and, in one trial, improvements in the composite measure of days alive or free of ventilator support at day 28 of the trial (the last day evaluated).8 There have been other trials evaluating iNO in the context of ARDS, which have demonstrated mixed results.6,7,9 In an in vitro study, inhaled nitric oxide has demonstrated an inhibitory effect on the replication cycle of severe acute respiratory syndrome-related coronavirus (SARS-CoV).10 Furthermore, a small clinical trial in SARS-CoV patients demonstrated improvements in blood oxygenation, a reduction in supplemental oxygen and a reduction in the amount of ventilator support.11
“This is an important day for patients and healthcare providers,” said Chris Miller, Ph.D., 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 U.S. Food and Drug Administration 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. Please see Important Safety Information below. The safety and efficacy of INOmax and iNO for pulmonary complications associated with COVID-19 have not been established.
ABOUT MALLINCKRODT
Mallinckrodt is a global business consisting of multiple wholly owned subsidiaries that develop, manufacture, market and distribute specialty pharmaceutical products and therapies. The company’s Specialty Brands reportable segment’s areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, nephrology, pulmonology and ophthalmology; immunotherapy and neonatal respiratory critical care therapies; analgesics and gastrointestinal products. Its Specialty Generics reportable segment includes specialty generic drugs and active pharmaceutical ingredients. To learn more about Mallinckrodt, visit www.mallinckrodt.com.
Mallinckrodt uses its website as a channel of distribution of important company information, such as press releases, investor presentations and other financial information. It also uses its website to expedite public access to time-critical information regarding the company in advance of or in lieu of distributing a press release or a filing with the U.S. Securities and Exchange Commission (SEC) disclosing the same information. Therefore, investors should look to the Investor Relations page of the website for important and time-critical information. Visitors to the website can also register to receive automatic e-mail and other notifications alerting them when new information is made available on the Investor Relations page of the website.
ABOUT NOVOTERIS, LLC
Novoteris, LLC is a privately held limited liability company managed by a group of international industry veterans and clinicians involved in developing and producing innovative, cutting-edge medical products. The company was formed in 2013 to consolidate the nitric oxide assets and other resources from 12th Man Technologies, Inc. (Garden Grove, CA) and Nitric Solutions, Inc. (Vancouver, Canada) for the completion of inhaled nitric oxide trials for the treatment of patients with cystic fibrosis. The company received Orphan Drug designations for the treatment of cystic fibrosis from both the FDA and EMA in 2013. Novoteris is headquartered in Garden Grove, California with an EU entity in Belgium (Novoteris GVC). For additional information, please visit www.novoteris.com.
