Mallinckrodt and Novoteris have secured approval from the Therapeutic Products Directorate of Health Canada to begin the pilot clinical trial of high-dose inhaled nitric oxide (iNO) therapy for COVID-19 infection and associated lung complications.

The joint pilot clinical trial, dubbed “Inhaled Gaseous Nitric Oxide (gNO) Antimicrobial Treatment of Difficult Bacterial and Viral Lung (COVID-19) Infections”, will evaluate the use of Thiolanox high-dose iNO therapy to treat patients infected with novel coronavirus at Vancouver Coastal Health Authority facilities.

The COVID-19 is a contagious respiratory illness resulted due to the novel coronavirus called SARS-CoV-2.

Novoteris founder and president Alex Stenzler said: “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.”

The companies will use Novoteris’ Inhaled Nitric Oxide Delivery Device (INODD) and Mallinckrodt’s high-concentration 5000 PPM nitric oxide gas for inhalation canisters to evaluate investigative therapy.

Mallinckrodt and Novoteris will soon begin the recruitment of patients in the trial

Mallinckrodt and Novoteris will commence the enrolment of patients in the study in the coming days.

The iNO was assessed in randomised controlled trials in both paediatric and adult patients with acute respiratory distress syndrome (ARDS).

According to Mallinckrodt, the therapy showed partially dose-dependent improvement in blood oxygenation and decreased pulmonary artery pressure, as well as improvements in the composite measure of days alive or free of ventilator support at day 28 of one trial.

At present, Mallinckrodt is coordinating with the US Food and Drug Administration to make its INOmax gas available to US patients with pulmonary complications of COVID-19.

Mallinckrodt executive vice president and chief scientific officer Dr Steven Romano said: “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.”

In 2017, IBA Molecular (IBAM) completed the acquisition of Mallinckrodt’s nuclear imaging business for about $690m.